Buspirone is an anti-anxiety medicine that affects chemicals in the brain that may be unbalanced in people with anxiety.

Buspirone is used to treat symptoms of anxiety, such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms.

Buspirone is not an anti-psychotic medication and should not be used in place of medication prescribed by your doctor for psychotic disorders.

Warnings

Do not use buspirone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Before taking this medicine

You should not use buspirone if you are allergic to it.

Do not use buspirone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure this medicine is safe for you, tell your doctor if you have any of these conditions:

• kidney disease; or
• liver disease.

Buspirone is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether buspirone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Buspirone is not FDA-approved for use by anyone younger than 18 years old, but this medicine has been used in children and adolescents under close medical supervision and at the appropriate dosage.

How should I take buspirone?

Take buspirone exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take buspirone with or without food but take it the same way each time.

Some buspirone tablets are scored so you can break the tablet into 2 or 3 pieces in order to take a smaller amount of the medicine at each dose. Do not use a tablet if it has not been broken correctly and the piece is too big or too small. Follow your doctor’s instructions about how much of the tablet to take.

If you have switched to buspirone from another anxiety medication, you may need to slowly decrease your dose of the other medication rather than stopping suddenly. Some anxiety medications can cause withdrawal symptoms when you stop taking them suddenly after long-term use.

This medication can cause false positive results with certain medical tests. You may need to stop using the medicine for at least 48 hours before your test. Tell any doctor who treats you that you are using buspirone.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol may increase certain side effects of buspirone.

Grapefruit and grapefruit juice may interact with buspirone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Buspirone side effects

Get emergency medical help if you have any signs of an allergic reaction to buspirone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain;
• shortness of breath; or
• a light-headed feeling, like you might pass out.

Common buspirone side effects may include:

• headache;
• dizziness, drowsiness;
• sleep problems (insomnia);
• nausea, upset stomach; or
• feeling nervous or excited.

BuSpar is an anti-anxiety medicine that affects chemicals in the brain that may be unbalanced in people with anxiety.

BuSpar is used to treat anxiety disorders or the symptoms of anxiety, such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms.

BuSpar is not an anti-psychotic medication and should not be used in place of medication prescribed by your doctor for mental illness.

BuSpar may also be used for purposes not listed in this medication guide.

Warnings

Do not use BuSpar if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Before taking this medicine

You should not use BuSpar if you are allergic to buspirone.

Do not use BuSpar if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure BuSpar is safe for you, tell your doctor if you have any of these conditions:

• kidney disease; or
• liver disease.

BuSpar is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether buspirone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Buspirone is not FDA-approved for use by anyone younger than 18 years old, but has been used in children in adolescents under close medical supervision. Do not give buspirone to anyone younger than 18 years of age without consulting with a doctor.

How should I take BuSpar?

Take BuSpar exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take BuSpar with or without food but take it the same way each time.

Some BuSpar tablets are scored so you can break the tablet into 2 or 3 pieces in order to take a smaller amount of the medicine at each dose. Do not use a tablet if it has not been broken correctly and the piece is too big or too small. Follow your doctor’s instructions about how much of the tablet to take.

If you have switched to BuSpar from another anxiety medication, you may need to slowly decrease your dose of the other medication rather than stopping suddenly. Some anxiety medications can cause withdrawal symptoms when you stop taking them suddenly after long-term use.

Buspirone can cause false positive results with certain medical tests. You may need to stop using the medicine for at least 48 hours before your test. Tell any doctor who treats you that you are using BuSpar.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Although no deaths have been reported following BuSpar overdose, symptoms may include nausea, vomiting, dizziness, drowsiness or sleepiness, and stomach upset.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol may increase certain side effects of BuSpar.

Grapefruit and grapefruit juice may interact with buspirone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

BuSpar side effects

Get emergency medical help if you have any signs of an allergic reaction to BuSpar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain;
• shortness of breath; or
• a light-headed feeling, like you might pass out.

Common BuSpar side effects may include:

• headache;
• dizziness, drowsiness;
• sleep problems (insomnia);
• nausea, upset stomach; or
• feeling nervous or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect BuSpar?

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. The following medications can interact with BuSpar;

• MAO Inihibitors (including isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine as well as methylene blue injection);
• Amitriptyline;
• Diazepam;
• Haloperidol;
• Nefazodone;
• Trazodone;
• Triazolam or flurazepam;
• Diltiazem or verapamil;
• Antibiotics, including erythromycin and rifampin;
• Antifungals, including itraconazole; or
• Cimetidine.

Benadryl is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Benadryl is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Benadryl is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson’s disease.

Warnings

You should not use Benadryl to make a child sleepy.

When taking Benadryl, use caution driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Benadryl.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Before taking this medicine

You should not use Benadryl if you are allergic to diphenhydramine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• blockage in your digestive tract (stomach or intestines);
• bladder obstruction or other urination problems;
• a colostomy or ileostomy;
• liver or kidney disease;
• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• heart disease, low blood pressure;
• glaucoma;
• a thyroid disorder; or
• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether Benadryl will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

Diphenhydramine can pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Ask a doctor before using this medicine if you are breast-feeding.

Older adults may be more likely to have side effects from this medicine.

How should I take Benadryl?

Use Benadryl exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use Benadryl to make a child sleepy.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

For motion sickness, take Benadryl 30 minutes before you will be in a situation that causes you motion sickness (such as a long car ride, airplane or boat travel, amusement park rides, etc). Continue taking Benadryl with meals and at bedtime for the rest of the time you will be in a motion-sickness situation.

As a sleep aid, take Benadryl within 30 minutes before bedtime.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can affect the results of allergy skin tests. Tell any doctor who treats you that you are using Benadryl.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Benadryl is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Benadryl may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of diphenhydramine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of this type of medicine. Check the label to see if a medicine contains an antihistamine.

Benadryl side effects

Get emergency medical help if you have signs of an allergic reaction to Benadryl: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Benadryl and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;
• painful or difficult urination;
• little or no urinating;
• confusion, feeling like you might pass out; or
• tightness in your neck or jaw, uncontrollable movements of your tongue.

Common Benadryl side effects may include:

• dizziness, drowsiness, loss of coordination;
• dry mouth, nose, or throat;
• constipation, upset stomach;
• dry eyes, blurred vision; or
• day-time drowsiness or “hangover” feeling after night-time use.

Belsomra (suvorexant) is used to treat insomnia, to help if you fall asleep faster and stay asleep longer, so you have have a better nights sleep. Belsomra works on orexin receptors which plays a role in wakefulness, and helps regulate your sleep and wake cycle. Belsomra is a dual orexin receptor antagonists (DORAs).

Belsomra is a controlled substance, Schedule IV. Schedule IV controlled substances have a low potential for drug abuse and low risk of dependence. But some patients with a history of abuse or addiction may still be at an increased risk of abuse.

Belsomra is a tablet that you take half an hour before you go to bed.

Belsomra side effects

Common Belsomra side effects include strange dreams or drowsiness during the day after taking this medicine.

Serious Belsomra side effects

Get emergency medical help if you have signs of an allergic reaction to Belsomra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Call your doctor at once if you have:

• trouble moving or talking when you first wake up;
• a weak feeling in your legs;
• unusual thoughts or behavior;
• anxiety, agitation, depression;
• memory problems;
• confusion, hallucinations; or
• thoughts about hurting yourself.

You may be more likely to have side effects if you are overweight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not take more Belsomra than your doctor has prescribed.

You should not use Belsomra if you have narcolepsy.

Take Belsomra 30 minutes before bedtime. Never take this medicine if you do not have 7 hours to sleep before being active again.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.

Before taking this medicine

You should not use Belsomra if you are allergic to suvorexant, or if you have narcolepsy.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or thoughts about suicide;
• drug or alcohol abuse or addiction;
• breathing problems, sleep apnea (breathing stops during sleep);
• liver disease;
• sudden muscle weakness;
• excessive sleepiness during normal waking hours; or
• if you have ever fallen asleep at unexpected times.

Tell your doctor if you are pregnant or breastfeeding.

Belsomra is not approved for use by anyone younger than 18 years old.

How should I take Belsomra?

Take Belsomra exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Belsomra may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take Belsomra only once per night, 30 minutes before bedtime.

You may take Belsomra with or without food. Avoid taking the medicine shortly after eating a meal, or the medicine may take longer to work.

Belsomra will make you fall asleep. Never take this medicine if you do not have 7 hours to sleep before being active again.

You may have trouble speaking or moving while you are falling asleep. It may take longer for you to wake up, speak, or move around when you wake up. You may feel like you are still dreaming for several minutes after waking.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using Belsomra for 7 to 10 nights in a row.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Dosing information

Usual Adult Dose for Insomnia:

10 mg orally once a day at bedtime
Maximum dose: 20 mg once a day

Comments:
-Take within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening.
-If 10 mg is well-tolerated but not effective, the dose can be increased.
-Time to effect may be delayed if taken with or soon after a meal.

Use: Insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

What happens if I miss a dose?

Since Belsomra is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medicine if you do not have 7 hours to sleep before being active again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

For at least 8 hours after taking Belsomra, do not drive or do anything that requires you to be alert. Your reactions may be impaired.

Avoid drinking alcohol. Do not take Belsomra if you have consumed alcohol within a few hours before getting ready for sleep.

What other drugs will affect Belsomra?

Using Belsomra with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

What is hydroxyzine?

Hydroxyzine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of itching, or hives on the skin. Hydroxyzine may be used to treat allergic skin reactions such as hives or contact dermatitis.

Since hydroxyzine also reduces activity in the central nervous system, it can be used as a sedative to treat anxiety and tension. It is also used together with other medications given during and after general anesthesia.

Hydroxyzine is also used to treat allergic skin reactions such as hives or contact dermatitis.

Warnings

Hydroxyzine may cause birth defects. Talk to you doctor before using hydroxyzine if pregnant or breastfeeding.

Hydroxyzine can cause a serious heart problem, especially if you use certain medicines at the same time. Tell your doctor about all your current medicines and any you start or stop using.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Stop using this medicine and call your doctor at once if you have a serious side effect such as tremors, confusion, seizures, or restless muscle movements in your eyes, tongue, jaw, or neck.

Drinking alcohol can increase certain side effects of hydroxyzine.

Before taking this medicine

You should not use hydroxyzine if you are allergic to it, or if:

• you have long QT syndrome;
• you are allergic to cetirizine (Zyrtec) or levocetirizine (Xyzal); or

Hydroxyzine could harm the unborn baby or cause birth defects. Talk to you doctor before using hydroxyzine if pregnant.

To make sure this medicine is safe for you, tell your doctor if you have:

• blockage in your digestive tract (stomach or intestines);
• bladder obstruction or other urination problems;
• glaucoma;
• heart disease, slow heartbeats;
• personal or family history of long QT syndrome;
• an electrolyte imbalance (such as high or low levels of potassium in your blood);
• if you have recently had a heart attack.

It is not known whether hydroxyzine passes into breast milk or if it could harm a nursing baby. Talk to your doctor before breastfeeding while using this medicine.

Do not give this medicine to a child without medical advice.

How should I take hydroxyzine?

Take hydroxyzine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Hydroxyzine is for short-term use only.

You should not take this medicine for longer than 4 months. Call your doctor if your anxiety symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, nausea, vomiting, uncontrolled muscle movements, or seizure (convulsions).

What to avoid

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

Hydroxyzine side effects

Get emergency medical help if you have signs of an allergic reaction to hydroxyzine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydroxyzine may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have sudden skin redness or a rash that spreads and causes white or yellow pustules, blistering, or peeling.

Stop using hydroxyzine and call your doctor at once if you have:

• fast or pounding heartbeats;
• headache with chest pain;
• severe dizziness, fainting; or
• a seizure (convulsions).

Side effects such as drowsiness and confusion may be more likely in older adults.

Common hydroxyzine side effects may include:

• drowsiness;
• headache;
• dry mouth; or
• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect hydroxyzine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking hydroxyzine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Hydroxyzine can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine.

Other drugs may interact with hydroxyzine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Hydroxyzine Pamoate Description

Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4- [2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy- 3-naphthalene carboxylic acid).

Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Yellow 10, Green 3, Yellow 6, Red 33, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.

Hydroxyzine Pamoate – Clinical Pharmacology

Hydroxyzine pamoate is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines.

Hydroxyzine pamoate is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and Hydroxyzine pamoate’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

Indications and Usage for Hydroxyzine Pamoate

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Contraindications

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Hydroxyzine is contraindicated in patients with a prolonged QT interval.

Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

Warnings

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Precautions

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Hydroxyzine pamoate. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

QT Prolongation/Torsade de Pointes (TdP)

Cases of QT prolongation and Torsade de Pointes have been reported during postmarketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.

Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).

Acute Generalized Exanthematous Pustulosis (AGEP)

Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema. Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity.

Geriatric Use

A determination has not been made whether controlled clinical studies of Hydroxyzine pamoate included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

The extent of renal excretion of Hydroxyzine pamoate has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of Hydroxyzine pamoate and observed closely.

Adverse Reactions/Side Effects

Side effects reported with the administration of Hydroxyzine pamoate are usually mild and transitory in nature.

Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

Cardiac System: QT prolongation, Torsade de Pointes.

In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: allergic reaction, Nervous System: headache, Psychiatric: hallucination, Skin and Appendages: pruritus, rash, urticaria.

Overdosage

The most common manifestation of overdosage of Hydroxyzine pamoate is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action.) Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects.

Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

Hydroxyzine Pamoate Dosage and Administration

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg 4 times daily; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.

For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg 3 times daily or 4 times daily; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

How is Hydroxyzine Pamoate supplied

Hydroxyzine pamoate capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride)

Store below 30°C (86°F). Dispense in tight, light-resistant containers (USP).

This product’s label may have been updated. For full prescribing information, please visit www.greenstonellc.com.

LAB-1402-1.0
Revised: February 2020

PRINCIPAL DISPLAY PANEL – 100 Capsule Bottle Label (50mg)

NDC 59762-5420-1
100 Capsules

GREENSTONE® BRAND

hydroxyzine
pamoate
Capsules

50 mg*

Rx only

PRINCIPAL DISPLAY PANEL – 100 Capsule Bottle Label (25mg)

NDC 59762-5410-1
100 Capsules

GREENSTONE® BRAND

hydroxyzine
pamoate
Capsules

25 mg*

Rx only

What is Lunesta?

Lunesta is a sedative, also called a hypnotic. It affects chemicals in your brain that may be unbalanced in people with sleep problems (insomnia).

Lunesta (eszopiclone) is used to treat insomnia. Symptoms include trouble falling asleep or waking up often during the night. Lunesta’s effects typically begin within 30 minutes and it helps reduce the time it takes to fall asleep and increases the total time spent sleeping. 

Lunesta’s mechanism of action is thought to involve enhancing the effects of GABA, the main inhibitory neurotransmitter in the brain. This slows down brain activity and promotes sleep. Lunesta is not a benzodiazepine but it has benzodiazepine-like effects; notably a more selective binding profile that targets specific GABA receptors involved in sleep. Lunesta belongs to the drug class called non-benzodiazepine sedative-hypnotics.

Lunesta gained FDA approval on December 15, 2004. Lunesta is a Schedule IV controlled substance which means there are limits on how much can be dispensed because of its potential for abuse and dependence.

• Keep Lunesta in a safe place to prevent misuse and abuse.
• Selling or giving away Lunesta may harm others, and is against the law. 

Lunesta side effects

The most common side effects of Lunesta are:

• an unpleasant taste in the mouth or a dry mouth
• day-time drowsiness or a “hangover” feeling. You may still feel drowsy the next day after taking Lunesta. Do not drive or do other dangerous activities after taking Lunesta until you feel fully awake
• dizziness
• headache
• symptoms of the common cold.

Serious side effects and warnings

Lunesta carries a Boxed Warning for Complex Sleep Behaviors.

Complex Sleep Behaviors have caused serious injury and death. After taking Lunesta, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with Lunesta whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities and behaviors include doing activities when you are asleep like:

• making and eating food
• talking on the phone
• having sex
• driving a car (“sleep-driving”)
• sleepwalking.

Stop taking Lunesta and call your healthcare provider right away if you find out that you have done any of the above activities after taking Lunesta.

The morning after you take Lunesta your ability to drive safely and think clearly may be decreased. You also may experience sleepiness during the day. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Worsening depression, including suicidal thoughts and actions, has been reported in patients with pre-existing depression in association with the use of sedatives such as Lunesta. Tell your healthcare provider if your mood worsens or you have thoughts of harming yourself.

Lunesta will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 8 hours to dedicate to sleeping.

Do not drink alcohol while you are taking Lunesta. It can increase some of the side effects, including drowsiness.

Lunesta may be habit-forming and should be used only by the person it was prescribed for. Lunesta should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms if you stop taking Lunesta after taking it over several days in a row. Do not stop taking this medicine suddenly without first talking to your doctor. You may need to taper off the dosage (use less and less) before you stop the medication completely.

Lunesta may cause a severe allergic reaction. Stop taking Lunesta and get emergency medical help if you have signs of an allergic reaction to Lunesta such as hives; nausea, vomiting; difficulty breathing; or swelling of your face, lips, tongue, or throat. 

Call your doctor at once if you have:

• anxiety, depression, aggression, agitation;
• memory problems, unusual thoughts or behavior;
• thoughts of hurting yourself; or
• confusion, hallucinations (hearing or seeing things).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking

Do not take Lunesta if you:

• are allergic to Lunesta, eszopiclone, or any of the inactive ingredients in the tablets
• have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone, or having sex while not fully awake) after taking Lunesta or any other sleep medicine
• drank alcohol that evening or before bed
• take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Lunesta with your other medicines.
• cannot get a full night’s sleep
• are younger than 18 years old.

Lunesta is not approved for use by anyone younger than 18 years old.

Before starting Lunesta, tell your doctor about all of your health conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug, substance, or alcohol abuse or addiction
• have ever abused or been dependent on prescription medicines
• have liver disease
• have a breathing disorder
• have depression, a mental illness, or suicidal thoughts
• are pregnant or planning to become pregnant
• are breastfeeding or plan to breastfeed.

The sedative effects of Lunesta may be stronger in older adults and accidental falls and injuries are more common in elderly patients who take sedatives. 

Pregnancy

It is not known if Lunesta will harm an unborn baby. Talk to your healthcare provider about the risks associated with Lunesta use during pregnancy.

Breastfeeding

It is not known if Lunesta passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby if you are taking Lunesta.

How should I take Lunesta?

Take Lunesta exactly as it was prescribed for you. Do not take more Lunesta than is prescribed for you.

• Take Lunesta right before you get into bed.
• Do not take Lunesta with or right after a meal.
• Do not take Lunesta unless you are able to get a full night’s sleep, and there are at least 7 to 8 hours before you must be active again.

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.

Lunesta may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Do not stop using Lunesta suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Insomnia symptoms may also return after you stop taking Lunesta and may be even worse than before. Tell your doctor if your insomnia worsens after stopping Lunesta.

Lunesta dosing

Use the lowest effective Lunesta dose.

Usual Adult Lunesta Dose for Insomnia:

Initial dose: Lunesta 1 mg orally, once a day immediately before bedtime.

• The dosage of Lunesta may be increased to 2 mg or 3 mg if insomnia persists after 7 to 10 days of treatment, but doing this may increase the risk of sleepiness the next day.
• The maximum dose of Lunesta is 3 mg/day.

Usual Geriatric Lunesta Dose for Insomnia:

Initial dose: Lunesta 1 mg orally, once a day immediately before bedtime.

• The dosage of Lunesta may be increased to 2 mg if insomnia persists after 7 to 10 days of treatment, but doing this may increase the risk of sleepiness the next day.
• The maximum dose of Lunesta is 2 mg/day.

What happens if I miss a dose?

Since Lunesta is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medicine if you do not have at least 7 to 8 hours to sleep before being active again.

Do not take two doses at one time.

What happens if I overdose?

If you take too much Lunesta or overdose, seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of eszopiclone can be fatal, especially when it is taken together with other medications that can cause drowsiness.

What to avoid

Avoid taking Lunesta during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get at least 8 hours of sleep after taking Lunesta.

Avoid drinking alcohol with Lunesta. Dangerous side effects or death could occur.

Avoid taking Lunesta within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.

Lunesta can cause side effects that may impair your thinking or reactions. You may still feel sleepy the next day after taking this medicine. Until you know how this medicine will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

What is melatonin?

Melatonin is an oral, over-the-counter (OTC) dietary supplement available without a prescription in the U.S. It is often used to help with jet lag or trouble sleeping and comes as tablets, capsules, an oral liquid and chewable gummies.

Melatonin is also a natural hormone your body secretes in response to darkness to help maintain your wake-sleep cycle (also called “biological clock”). The wake-sleep cycle is the process of sleep and wakefulness; in humans this averages 8 hours of nighttime sleep and 16 hours of daytime activity.

Natural melatonin levels usually peak between 11PM and 3AM. Nighttime levels are roughly 10 times higher than in the daytime. Levels fall sharply before daylight, and are barely detectable in the daylight hours. The rise and fall in natural levels signal wake and sleep times, known as our circadian rhythm.

Shorter periods of natural melatonin production occur in the summer with longer days, and longer periods of production occur in the winter. Light at night (such as from smartphones or the TV) blocks production and can lead to sleep disturbances. Age also lowers nighttime melatonin release, which may contribute to the problem of insomnia and early awakening often seen in older adults.

What is melatonin used for?

Melatonin is most commonly used to treat:

• insomnia (trouble sleeping)
• jet lag due to travel
• sleep cycles in the blind (non 24-Hour Sleep Wake Disorder)
• shift-work sleep disorders in people with alternating work schedules

Melatonin dietary supplements may be promoted for many other uses, from eczema, to bowel disorders to cancer treatment, but adequate studies are lacking. It has been widely studied for treatment of jet lag and other sleep disorders.

How does melatonin work?

Natural melatonin is a hormone produced in the pineal gland in the brain. It is made from the amino acid tryptophan and then released into the blood and cerebrospinal fluid, crossing into the brain. It sends messages to areas in the brain and body to help control the sleep and wake cycles.

When taken as a dietary supplement, its function is to act like the natural sleep hormone. Drowsiness generally occurs within 30 minutes after taking a dose.

Taking supplemental melatonin for sleep before bedtime may not be the best strategy for all sleep disorders and may not work for everyone. Trouble with sleep may be a symptom of other medical disorders, like depression, anxiety or sleep apnea, so check with your doctor if your insomnia persists. Also check with a child’s doctor before use.

Is melatonin a hormone or a vitamin?

Melatonin is a natural hormone when produced in the body and is not a vitamin. Melatonin supplements you take by mouth – like pills, liquids or chewable gummies – are man-made products available without a prescription at the pharmacy, nutrition stores, and other retail shops.

Before taking this medicine

Do not use melatonin if you are allergic to it.

Before using this medication or giving it to your child, talk to your healthcare provider. This medication may not be recommended if you have certain medical conditions, such as:

• diabetes
• depression
• a bleeding or blood clotting disorder such as hemophilia
• taking a blood thinner like warfarin
• high or low blood pressure
• epilepsy or other seizure disorder
• if you are using any medicine to prevent organ transplant rejection
• an autoimmune condition
• using other sedatives or tranquilizers

It is not known whether this medication will harm an unborn baby. Do not use this product without medical advice if you are pregnant.

High doses of this medicine may affect ovulation, making it difficult for you to get pregnant.

It is not known whether melatonin passes into breast milk or if it could harm a nursing baby. Do not use this product without medical advice if you are breast-feeding a baby.

Do not give any herbal or dietary supplement to a child without medical advice from a qualified healthcare provider.

Melatonin dosage

Melatonin is considered an effective short-term treatment for jet lag and may aid with sleep during times when you would not normally be awake.

Effective starting doses of melatonin for jet lag range from 0.3 to 0.5 mg. One milligram tablets can be cut in half to achieve a 0.5 mg dose of melatonin if smaller doses are not available for purchase. Higher doses are commonly marketed in the U.S. (up to 10 mg), but higher doses may be associated with more side effects such as headache, next day drowsiness, or vivid dreams. Side effects of melatonin may occur more frequently or worsen in older adults.

Always start with the lowest dose. According to a Cochrane review, doses over 5 mg appear to be no more effective than lower doses. Higher doses may result in excessively high levels of physiologic melatonin.

Melatonin for jet lag

Jet lag is an air travel problem that causes trouble with falling and staying asleep, fatigue, trouble concentrating, constipation, and other symptoms. Jet lag is much more likely if you cross over several time zones, and can worsen the more time zones you cross.

Effective starting doses for jet lag range from 0.3 to 0.5 mg. Smaller doses may work for some while others may need a higher dose. It may be more difficult to fly east, when time is lost, rather than to fly west, when you gain it back. High doses, such as 20 mg pills are available for purchase on the Internet, but such high doses are not normally recommended or needed, and may greatly increase side effects.

• Eastbound: If you are traveling east, say from the US to Europe, take supplemental melatonin for sleep after dark, 30 minutes before bedtime in the new time zone or if you are on the plane. Then take it for the next 4 nights in the new time zone, after dark, 30 minutes before bedtime. If you are still feeling drowsy the day after using this medication, try a lower dose.
• Westbound: If you are heading west, for example, from the US to Australia, a dose is not needed for your first travel night, but you then may take it for the next 4 nights in the new time zone, after dark, 30 minutes before bedtime. Melatonin may not always be needed for westbound travel.

Given enough time (usually 3 to 5 days), jet lag will usually resolve on its own, but this is not always optimal when traveling.

Melatonin for sleep disorders

Primary Sleep Disorders (Insomnia):

• Dosage: Take 0.1 mg to 0.5 mg thirty minutes before bedtime. Studies suggest supplemental melatonin for primary sleep disorders may be effective in promoting but not maintaining sleep (early morning awakening). It is not usually recommended for long-term use. If insomnia continues, seek the advice of a healthcare provider.

Shift-Work Sleep Disorders

• Dosage: Take 1 to 3 mg thirty minutes prior to the desired onset of daytime sleep; melatonin may NOT lead to improved alertness during the nighttime work shift.

Delayed Sleep-Wake Phase Disorder

Delayed sleep-wake phase disorder (DSWPD) most often occurs in adolescents, possibly due to reduced production and melatonin deficiency at this age. Sleep onset is delayed by 3 to 6 hours compared with conventional bedtimes (10 to 11 pm). DSWPD can negatively affect school performance, daily activities, and lead to morning drowsiness which can be dangerous for teen drivers. Any sleep disorder in an adolescent should be evaluated by a physician.

• Dosage: No consensus is available for dosing in DSWPS. Some clinicians recommend 3 to 5 mg taken in the early evening, at least 1.5 hours before the desired bedtime. Bright light therapy and behavioral management may enhance results. Be aware drowsiness may occur after the melatonin dose, so avoid hazardous activities such as driving.

Non-24-Hour Sleep Wake Disorder (Non-24)

More than 70% of people who are totally blind have Non-24, a circadian rhythm disorder. For people who are totally blind, there are no light cues to help reset the biological clock. The sleep time and wake up time of people who have Non-24-Hour Sleep Wake Disorder shifts a little later every day. Sleep times go in and out of alignment compared to a normal sleep-wake phase. Extra minutes add up each day by day and disrupt the normal wake-sleep pattern.

Use of melatonin in Non-24 is to aid in stimulation to reset the biological clock with one long sleep time at night and one long awake time during the day.

• Dosage: Studies on people who are the blind suggest 0.5 mg/day, taken either at a fixed time before bed or one hour before bedtime.

Hetlioz, a prescription-only melatonin agonist is approved for use in Non-24-Hour Sleep Wake Disorder in adults and for the treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) in patients 3 years of age and older.

• Hetlioz (tasimelteon)

Rozerem (ramelteon), also a melatonin agonist, has been approved to treat insomnia characterized by difficulty with sleep onset in adults.

• Hetlioz (tasimelteon)Rozerem (ramelteon)

Fast-dissolving Tablets

Some melatonin tablets are available in fast-dissolving formulations in the U.S. To take the orally disintegrating tablet:

• Use dry hands to remove the tablet and place it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Call your doctor if the condition you are treating with this medication does not improve, or if it gets worse while using this product.

Store at room temperature away from moisture and heat.

Melatonin for Children

Parents may consider using melatonin to help their child who has a trouble falling asleep. Only use this medication for your child under the care of a pediatrician or other medical sleep specialist. Insomnia or other sleeping disorders in children should always be evaluated by a medical professional.

Melatonin should not be used as a substitute for good sleep hygiene and consistent bedtime routines in children. According to Yale sleep specialist Dr. Craig Canapari, use of this medication results in less difficulty with falling asleep, earlier time of sleep onset, and more sleep at night.

Products containing lower-dose melatonin for kids do exist on the U.S. market. Long-term use of this medication has not been studied in clinical trials for children and possible side effects with prolonged use are not known. The use of melatonin in children with autism spectrum disorder or attention-deficit hyperactivity disorder should involve behavioral interventions and should be directed by a physician.

Delayed sleep phase disorder often occurs in teenagers and young adults, possibly due to alterations in endogenous production. Sleep onset is delayed by 3 to 6 hours compared with normal bedtime hours of 10 to 11 PM. Maintaining a consistent bedtime free of electronics for at least one hour prior to bedtime is especially important for insomnia in children and adolescents.

Melatonin Side Effects in Children

The most common melatonin side effect in children is morning drowsiness. Other common side effects in children include:

• Bedwetting
• Headache
• Dizziness
• Nausea
• Diarrhea
• Possible increased risk for seizures in children with severe neurological disorders.

Dietary melatonin supplements can still have drug interactions or health risks if you have certain medical conditions, upcoming surgery, or other health concerns.

What to avoid

• Avoid driving or operating machinery for at least 4 hours after taking melatonin, or until the drowsy effects are no longer present.
• Avoid using this medication with other prescription medications, over-the-counter drugs, or dietary supplements without asking your doctor, pharmacist or other healthcare provider.
• Avoid alcohol while taking this medication.
• Avoid coffee, tea, cola, energy drinks, or other products that contain caffeine, as it may counteract the effects of the melatonin.

What Happens if I Miss a Dose?

If you miss taking a dose there is no cause for concern, but melatonin may impair your thinking and reaction time. If you will be driving or doing any hazardous activity, skip your dose as melatonin can cause drowsiness.

Otherwise, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine or double your dose to make up the missed medication.

Can You Overdose?

Melatonin is thought to be very safe in the short-term with a low risk for overdose. If you suspect an overdose or serious adverse effects or allergic reactions, seek emergency medical attention from your health care provider or call the Poison Help Line .

Is Melatonin Safe?

Melatonin is a relatively safe supplement when used in the short-term, and melatonin side effects are uncommon. Its safety in the long-term has not been determined in randomized, controlled studies. In general this medication appears to be relatively nontoxic, even at higher doses such as 3 to 5 mg once a day.

Some people can have side effects from melatonin that may include:

• daytime drowsiness, dizziness, weakness, or confusion
• vivid dreams, nightmares
• feeling depressed, anxious, irritable
• headache
• loss of appetite, diarrhea, nausea, stomach pain
• blood pressure changes
• joint or back pain
• elevated risk for seizures

Higher external doses(>1 mg to 10 mg) can worsen side effects like daytime drowsiness, impaired physical or mental ability, low body temperature, and elevated prolactin levels.

Melatonin and Pregnancy

Most dietary supplements like melatonin have not been studied in pregnant women, during breastfeeding, or in children. Seek advice from your healthcare provider before using any dietary supplement if you are pregnant, nursing, or considering the use of this product in a child under 18 years of age.

Melatonin Drug Interactions

Some important drug interactions can occur with melatonin even though it is a dietary supplement. Always review for drug, food and disease interactions with your healthcare provider anytime you start, or even stop, a medication.

Always tell your doctor and pharmacist about all of the medications you take, including prescription drugs, over-the-counter medicines, vitamins and herbal supplements. Do not stop using any medications without first talking to your doctor.

Talk to your doctor before using melatonin if you take the blood thinner warfarin. Melatonin has been reported to increase the effects of warfarin in some patients. This is not a complete list of drug interactions that may occur with melatonin.

Is Melatonin Approved by the FDA?

Melatonin is not approved by the FDA for any use. It falls under the FDA’s Dietary Health and Education Act as a dietary supplement. Dietary supplements may include vitamins, minerals, amino acids, and herbs or botanicals, plus other substances used to supplement the diet. As with other dietary supplements, melatonin isn’t approved by the Food and Drug Administration (FDA) for safety or effectiveness.

Manufacturers must notify FDA about new ingredients prior to marketing. After the supplement is on the market, the FDA will monitor adverse event/s that are reported to them by the manufacturer, consumers or health care professionals. If a manufacturer makes an unproven health claim or if the supplement is found to be unsafe the FDA can remove the OTC from the market.

Avoid buying dietary supplements from the Internet and from online pharmacies whose authenticity you cannot verify. It is important to remember that an OTC label that says “natural” supplement does not always mean it’s “safe” for consumption. Formulations that are United States Pharmacopeial (USP) Convention Verified can be considered most reliable in this regard; the label “USP” is found on the outside of the bottle. For example, all Nature Made products are verified by the USP. The safest way to purchase drugs online is through pharmacies accredited by the Verification of Internet Pharmacy Practice Sites (VIPPS) programs.

Do Electronic Devices Alter Melatonin Levels?

Light at night blocks the production of melatonin, and this has been shown to cause sleep disturbances in people who use electronics that emit light at night. Researchers have found that light from electronic devices can block the release of natural hormone melatonin at night. The effect was most significant for younger children, with nighttime levels reduced by up to 37 percent in certain cases. This can also be problematic for children between ages 9 and 16.

Studies show that light after dark lowers melatonin levels which may lead to difficulty in initiating sleep. Electronic light-emitting devices such as the television, laptops, smartphones and tablets often find their way into the bedroom at night, or are used after dark. Children should not have electronics, including TVs, in their bedroom at bedtime and everyone should avoid use of light-emitting devices and screen time at least one hour before bedtime.

Melatonin Reviews and Studies

For Primary Sleep Disorders

Researchers have conducted many studies on melatonin supplements for various health conditions. Most studies have been conducted in sleep disorders, such as jet lag, shift work sleep disorders, delayed sleep phase disorder, and insomnia. Studies are often not consistent in their results and questions still remain about its usefulness, dosage, length of treatment and long-term safety for some sleep conditions.

Melatonin can be effective for jet lag for many people when dosed at the appropriate time. Studes measuring the effectiveness of melatonin for the treatment of insomnia show a slight reduction in the amount of time needed to fall asleep, but melatonin may not increase the overall quality of sleep. This medication does appear to be safe for short-term use for primary insomnia (less than three months).

For Other Conditions

Multiple areas for melatonin use have been investigated, but not all uses may be accepted or have adequate research to determine appropriate clinical use. These include:

• Cancer
• Boost the immune system
• Sunburn
• Irritable Bowel Syndrome (IBS)
• Fibromyalgia
• Systemic sclerosis
• Antioxidant and free radical scavenger
• Alzheimer’s disease
• Ocular diseases
• Sleep aid for children with autism spectrum disorder or attention deficit hyperactivity disorder (ADHD)
• Amyotrophic lateral sclerosis (ALS)
• Nighttime blood pressure control
• Seasonal affective disorder (SAD)

How Does Melatonin Come at the Store?

In the U.S., melatonin pills can be purchased without a prescription in the pharmacy, grocery, or health food store. Pill strengths range from 1 milligram (mg) to 10 mg, but you should always start with the lowest dose to judge its effects. Some experts suggest to start with 0.3 to 0.5 mg thirty minutes before bedtime, instead of the higher doses. Cut a 1-mg immediate release tablet in half to get a 0.5 mg dose if lower doses are not available; don’t do this with time release products. Also, don’t drink alcohol with the time-release preparation, as it can disrupt the time-release mechanism.

Does Food Contain Melatonin?

A study published in Food and Nutrition Research notes that certain food products do contain various amounts of melatonin as measured by immunological and chromatographic laboratory techniques. How consumption of these various foods might affect endogenous production sleep or was not evaluated:

• Tomatoes
• Walnuts
• Rice/barley cereal
• Strawberries, tart cherries
• Olive oil
• Wine, beer
• Cow’s milk

Research finds that melatonin synthesis depends upon availability of the essential amino acid tryptophan, a needed component of the diet. If intake of tryptophan is severely restricted, synthesis of melatonin is significantly reduced in humans.

In the Nurses’ Health Study, no link was found between the consumption of various nutrients, such as folate, vitamin B6 and zinc and increased urinary excretion.

Diets rich in vegetables, fruits and grain products will contain considerable levels of dietary melatonin. The overall effect of dietary consumption on nighttime levels of melatonin is very limited. Melatonin production is primarily driven by the effects of light and darkness and by age, declining as we get older.

How Much Does Melatonin Cost?

On average a 120-count bottle costs about $10.00, but prices can vary, depending upon the manufacturer and strengths purchased. Insurance usually will not pay for over-the-counter (OTC) products, although some plans may allow use of health savings account funds.

Bottom Line: Pros and Cons

Benefits:

• Widely available in the U.S. over-the-counter (OTC) without a prescription
• Short-term use (less than 3 months) is relatively safe with little evidence of toxicity
• Inexpensive product with generics or store brands available
• Lower dose and orally-dissolvable products for children are available
• Comes in a variety of dosage forms and doses

Downsides:

• Not approved for any uses by the FDA (over-the-counter dietary supplement)
• Quality of some products cannot always be assured
• Studies for less common uses are not consistent
• Doses tend to vary between patients; always ask a medical professional or your health care provider for dosing advice in children
• Effective lower doses (0.1 to 1 mg) are not always commercially available
• Higher doses (2 to 10 mg) used over a prolonged period may lead to rebound insomnia and are not well studied.

What is Quviviq?

Quviviq (daridorexant) is a prescription medicine that may be used to encourage sleep in adults who have trouble falling asleep or staying asleep (insomnia).

Quviviq’s mechanism of action involves blocking a chemical in the brain called orexin, that keeps the brain alert. Quviviq stops orexin from binding to its receptors, which helps the brain to calm down and prepare for sleep. Quviviq is designed to help adults fall asleep more easily and sleep through the night. Quviviq is not a benzodiazepine and belongs to the drug class called orexin antagonists .

Quviviq gained FDA approval on January 7, 2022. There is no Quviviq generic available.

Is Quviviq a controlled substance?

Quviviq is a federally controlled substance (schedule IV) because it can be abused or lead to dependence.

Keep Quviviq in a safe place to prevent misuse and abuse. Selling or giving away Quviviq may harm others and is against the law.

What does Quviviq cost?

Quviviq costs just over $500 for a supply of 30 tablets. Some people may be eligible for a Quviviq coupon or Quviviq copay card.

Quviviq side effects

The most common side effects of Quviviq are headache and sleepiness.

Quviviq has not been associated with weight gain.

Serious side effects and warnings

Quviviq may cause the following serious side effects.

Decreased awareness and alertness. The morning after you take Quviviq, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.

• Do not take more Quviviq than prescribed.
• Do not take Quviviq unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again.
• Take Quviviq in the evening within 30 minutes before going to bed.

Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying while taking Quviviq.

Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up. Quviviq may cause sleep paralysis or hallucinations. Talk to your healthcare provider immediately if you experience these.

Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex, or doing other activities while not fully awake that you may not remember the next morning, have been reported by people taking Quviviq. Stop taking Quviviq and call your healthcare provider right away if you experience any of these behaviors.

It is not known if Quviviq is safe and effective for use in children.

These are not all of the possible side effects. Call your doctor for medical advice about side effects.

Before taking

Do not take Quviviq if you have narcolepsy (a condition where you fall asleep suddenly, often at unexpected or inappropriate times.

Before taking Quviviq, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts or actions
• have a history of drug or alcohol abuse or addiction
• have a history of a sudden onset of muscle weakness (cataplexy)
• have a history of daytime sleepiness
• have lung or breathing problems, including sleep apnea
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Quviviq can harm your unborn baby. There is a pregnancy registry for women who are exposed to Quviviq during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. For more information or to participate in the registry, call 1-833-400-9611. Talk with your healthcare provider about the risk to your unborn baby if you take Quviviq during pregnancy.

Breastfeeding

It is not known if Quviviq passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

How should I take Quviviq?

Take Quviviq exactly as your healthcare provider tells you to take it. Do not change your dose without first talking to your healthcare provider.

• Take Quviviq 1 time each night, within 30 minutes before going to bed. 
• Only take Quviviq when you can stay in bed for a full night (at least 7 hours). There should be at least 7 hours remaining before you plan to wake up
• It may take Quviviq longer to start working if you take it with or soon after food.

Call your healthcare provider if you still can’t sleep properly and you have been taking Quviviq for 7 to 10 days. This may mean that another condition is causing your sleep problem.

Quviviq dosage

The usual adult dose of Quviviq is 25 mg to 50 mg once per night.

What happens if I take too much Quviviq?

If you take too much Quviviq or overdose, call your healthcare provider immediately or go to the nearest hospital emergency room right away.

What should I avoid while taking Quviviq?

Do not drink alcohol while taking Quviviq because it may increase the effects of alcohol or Quviviq, which may be dangerous.

You may still feel drowsy the next day after taking Quviviq.

• Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you have taken Quviviq as prescribed but do not feel fully awake, you have taken Quviviq and have less than a full night of sleep (at least 7 hours), or if you have taken more Quviviq than prescribed by your healthcare provider.

What other drugs will affect Quviviq?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Quviviq with certain medicines can cause serious side effects. Quviviq may affect the way other medicines work and other medicines may affect the way Quviviq works.

Taking Quviviq with medicines that have drowsiness as a side effect (such as sedating antihistamines, benzodiazepines, or muscle relaxants).

Do not take Quviviq with other medicines that are used to promote sleep, such as Ambien (see Quviviq vs Ambien).

Other drugs may affect Quviviq, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Quviviq storage

Store Quviviq at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children and pets.

Quviviq ingredients

Quviviq active ingredient: daridorexant hydrochloride
Quviviq inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, and silicon dioxide.

The tablet film coating contains: glycerin, hypromellose, iron oxide black, iron oxide red, microcrystalline cellulose, talc, titanium dioxide, and, in the 50 mg tablet only, iron oxide yellow.

What is ramelteon?

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your “sleep-wake cycle.”

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Ramelteon may also be used for purposes not listed in this medication guide.

Ramelteon side effects

Ramelteon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using ramelteon have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Ramelteon may cause serious side effects. Call your doctor at once if you have:

• unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;
• a missed menstrual period;
• nipple discharge; or
• loss of interest in sex.

Common side effects of ramelteon may include:

• drowsiness, tired feeling;
• dizziness;
• nausea; or
• worsening sleep problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use ramelteon if you are also taking fluvoxamine, or if you have ever had a severe allergic reaction to ramelteon.

Ramelteon may cause a severe allergic reaction. Get emergency medical help if you have hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.

Before taking this medicine

Ramelteon will make you fall asleep. Never take ramelteon during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

You should not use ramelteon if you are allergic to it, or if:

• you have severe liver disease; or
• you also take fluvoxamine.

Tell your doctor if you have ever had:

• liver disease;
• breathing problems;
• sleep apnea (breathing stops while you are asleep); or
• depression, mental illness, or suicidal thoughts.

Tell your doctor if you are pregnant or breastfeeding.

You should not breastfeed within 25 hours after using ramelteon. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

Ramelteon is not approved for use by anyone younger than 18 years old.

How should I take ramelteon?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take ramelteon 30 minutes before your normal bedtime.

Swallow the tablet whole and do not crush, chew, or break it.

Ramelteon should not be taken with or after a high-fat meal. This will make it harder for your body to absorb the medication.

Call your doctor if your symptoms do not improve after 7 to 10 days of using ramelteon.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Ramelteon dosing information

Usual Adult Dose for Insomnia:

8 mg orally within 30 minutes of going to bed

Maximum Dose: 8 mg per day

Comments: This drug should not be taken with or immediately after a high-fat meal.

Use: Treatment of insomnia characterized by difficulty with sleep onset

What happens if I miss a dose?

Since ramelteon is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medication if you do not have 7 to 8 hours to sleep before being active again.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ramelteon?

Do not drink alcohol with ramelteon.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

What is Atarax?

Atarax reduces activity in the central nervous system. It also acts as an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing and runny nose, or hives on the skin.

Atarax is used as a sedative to treat anxiety and tension. It is also used together with other medications given for anesthesia.

Atarax is also used to treat allergic skin reactions such as hives or contact dermatitis.

Atarax may also be used for purposes not listed in this medication guide.

Warnings

You should not use Atarax if you are allergic to hydroxyzine, or if you are pregnant.

Before you take Atarax, tell your doctor if you have a seizure disorder, liver disease, or kidney disease.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Stop using Atarax and call your doctor at once if you have a serious side effect such as tremors, confusion, seizures, or restless muscle movements in your eyes, tongue, jaw, or neck.

Drinking alcohol can increase certain side effects of hydroxyzine.

Before taking this medicine

You should not use Atarax if you are allergic to hydroxyzine, or if you are pregnant.

To make sure you can safely take Atarax, tell your doctor if you have any of these other conditions:

• epilepsy or other seizure disorder;
• asthma, emphysema, or other breathing problem;
• glaucoma;
• heart disease or high blood pressure;
• stomach ulcer, blockage in your stomach or intestines;
• thyroid disorder;
• enlarged prostate or problems with urination;
• liver disease; or
• kidney disease.

Do not use Atarax without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether hydroxyzine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medication.

How should I take Atarax?

Take Atarax exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Measure Atarax syrup with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include extreme drowsiness, nausea, vomiting, feeling like you might pass out.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Atarax.

Atarax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Atarax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Atarax and call your doctor at once if you have a serious side effect such as:

• restless muscle movements in your eyes, tongue, jaw, or neck;
• tremor (uncontrolled shaking);
• confusion; or
• seizure (convulsions).

Less serious Atarax side effects may include:

• dizziness, drowsiness;
• blurred vision, dry mouth; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Atarax?

Before using Atarax, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Atarax.

This list is not complete and other drugs may interact with hydroxyzine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What is Ambien?

Ambien is a sedative, also called a hypnotic. Ambien (zolpidem) affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Ambien is used to treat insomnia. The immediate-release tablet is used to help you fall asleep when you first go to bed. The extended-release form, Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Your doctor will determine which form of Ambien is best for you.

Warnings

Ambien may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not share Ambien with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Never take Ambien in larger amounts or for longer than prescribed.

Do not take zolpidem if you have consumed alcohol during the day or just before bed.

Before taking this medicine

Some people using Ambien have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking this medicine and talk with your doctor about another treatment for your sleep disorder.

You should not use Ambien if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.

Ambien is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or suicidal thoughts;
• drug or alcohol addiction;
• lung disease or breathing problems;
• sleep apnea (breathing stops during sleep); or
• liver or kidney disease.

Taking Ambien in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take Ambien?

Take Ambien exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed.

The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of Ambien are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Never take this medicine if you do not have a full 7 to 8 hours to sleep before being active again.

Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take this medicine for longer than 4 or 5 weeks without your doctor’s advice.

Do not stop using Ambien suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking Ambien, and may be even worse than before. Call your doctor if you still have worsened insomnia for the first few nights after you stop taking this medicine.

Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since Ambien is taken only at bedtime if needed, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What to avoid

Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy the morning after taking Ambien, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Ambien side effects

Zolpidem may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using this medicine and call your doctor at once if you have:

• chest pain, fast or irregular heartbeat, feeling short of breath;
• trouble breathing or swallowing; or
• feeling like you might pass out.

The sedative effect of Ambien may be stronger in older adults.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Common Ambien side effects may include:

• daytime drowsiness, dizziness, weakness, feeling “drugged” or light-headed;
• tired feeling, loss of coordination;
• stuffy nose, dry mouth, nose or throat irritation;
• nausea, constipation, diarrhea, upset stomach; or
• headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ambien?

Using Ambien with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is zaleplon?

Zaleplon is a sedative that is used to treat insomnia. zaleplon causes relaxation to help you fall asleep and stay asleep.

Zaleplon may also be used for purposes not listed in this medication guide.

Zaleplon side effects

Zaleplon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Zaleplon may cause serious side effects. Call your doctor at once if you have:

• anxiety, depression, aggression, agitation;
• memory problems, unusual thoughts or behavior;
• thoughts of hurting yourself; or
• confusion, hallucinations (hearing or seeing things).

Common side effects of zaleplon may include:

• day-time drowsiness, dizziness, “hangover” feeling;
• feeling light-headed;
• problems with coordination; or
• numbness, tingling, or prickly feeling on your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Warnings

Some people using zaleplon have engaged in activity while not fully awake and later had no memory of it. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Before taking this medicine

You should not use zaleplon if you are allergic to it, or if you have ever taken sleep medicine and engaged in activity you later don’t remember.

Zaleplon is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a breathing disorder;
• depression, mental illness, or suicidal thoughts; or
• drug or alcohol addiction.

You should not take zaleplon if you are pregnant.

You should not breastfeed while using zaleplon.

The sedative effects of zaleplon may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking zaleplon.

How should I take zaleplon?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Zaleplon may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away zaleplon is against the law.

Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have several hours to dedicate to sleeping.

Zaleplon is for short-term use only. Do not take zaleplon for longer than 5 weeks without your doctor’s advice.

Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.

Do not stop using zaleplon suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Insomnia symptoms may also return after you stop taking zaleplon, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking zaleplon.

Zaleplon dosing information

Usual Adult Dose for Insomnia:

10 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 20 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Usual Geriatric Dose for Insomnia:

5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 10 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

What happens if I miss a dose?

Since zaleplon is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medication if you do not have several hours to sleep before being active again.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zaleplon can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include severe drowsiness, confusion, loss of coordination, severe muscle weakness, weak or shallow breathing, fainting.

What should I avoid while taking zaleplon?

Avoid taking zaleplon during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get the equivalent of a full night’s sleep after taking zaleplon.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid taking zaleplon with food or right after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medicine.

Zaleplon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how zaleplon will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

What other drugs will affect zaleplon?

Using zaleplon with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, other sleep medicine, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect zaleplon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.