Nuvigil

Pronunciation: nu-vij-el
Generic name: armodafinil
Dosage form: oral tablets
Drug class: CNS stimulants 

What is Nuvigil?

Nuvigil (armodafinil) is an oral prescription medicine that may be used to improve wakefulness in adults who are very sleepy due to narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

• Nuvigil is taken in combination with other treatments for sleep disorders.
• Use of Nuvigil does not replace using your CPAP machine or other treatments that your doctor has prescribed for OSA. Continue to use these treatments.
• Nuvigil is not a cure. It may help the sleepiness caused by these conditions, but it may not stop all your sleepiness and does not take the place of getting enough sleep. Follow your doctor’s advice about good sleep habits and using other treatments.

Nuvigil’s mechanism of action is thought to involve dopamine transporter (DAT) inhibition, although the exact way it works for sleep disorders is not known. While similar to stimulants like amphetamine and methylphenidate, Nuvigil has a different chemical structure. Nuvigil belongs to the drug class called CNS stimulants. 

Nuvigil is classified as a Schedule IV (4) controlled substance due to its potential for misuse and dependence. Misuse is illegal and harmful and you should always keep it in a safe place and never share it with others. Tell your doctor if you have a history of substance abuse.

Nuvigil gained FDA approval on June 15, 2007. A Nuvigil generic is available under the name armodafinil.

Nuvigil side effects

The most common side effects of Nuvigil are:

• headache
• dizziness
• nausea
• sleep problems (insomnia).

Serious side effects and warnings

Nuvigil may cause serious side effects including a serious rash or serious allergic reactions including anaphylaxis, angioedema, and multiorgan hypersensitivity. These may need to be treated in a hospital and may be life-threatening. Stop taking Nuvigil and call your doctor right away or get emergency help if you have any of these symptoms:

• a severe skin reaction that spreads and causes blistering and peeling
• a skin rash, hives, or sores in your mouth
• fever, sore throat, or burning in your eyes
• swelling of your face, eyes, lips, tongue, throat, or lymph nodes
• trouble swallowing, breathing, or hoarseness
• shortness of breath, flu-like symptoms, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine.

Stop taking Nuvigil and seek urgent medical attention at the first sign of rash, no matter how minor it is, unless the rash is not drug-related. These rashes usually occur within 1 to 5 weeks after the first dose. 

Nuvigil may cause the following other serious side effects. 

Mental (psychiatric) symptoms. Symptoms such as depression, anxiety, agitation, nervousness, and irritability, some of which resulted in people stopping Nuvigil, have been reported. May not be suitable for people with a history of psychosis, depression, or mania. Tell your healthcare provider immediately if you develop symptoms such as:

• depression or thoughts of suicide
• hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• feeling anxious
• an extreme increase in activity and talking (mania)
• aggressive behavior.

Persistent sleepiness. Nuvigil may not return a person’s levels of wakefulness to normal and persistent sleepiness may continue despite taking Nuvigil. Tell your healthcare provider if you continue to be sleepy during the day and avoid driving or any other potentially dangerous activity. 

Cardiovascular events have been reported with Nuvigil including chest pain, high blood pressure, palpitations or abnormal heartbeats, shortness of breath, and ECG changes. Some of these patients had preexisting heart disease.  Seek urgent medical attention if you develop symptoms of a heart problem, including chest pain, abnormal heartbeats, or trouble breathing.

It is not known if Nuvigil is safe and effective in children under the age of 18 and it is not approved for use in children.

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

Before taking this medicine

You should not use Nuvigil if you have ever had a rash or allergic reaction caused by armodafinil, Nuvigil, modafinil (Provigil), or any of the inactive ingredients in Nuvigil tablets.

To make sure Nuvigil is safe for you, tell your doctor about all your medical conditions, including if you have ever had:

• liver or kidney disease
• heart disease or a heart muscle or valve disorder such as mitral valve prolapse
• high blood pressure, heart disease, or prior heart attack
• mental illness or psychosis
• drug or alcohol addiction.

Tell your healthcare provider if you are pregnant, intending to become pregnant, or breastfeeding.

Pregnancy

It is not known whether Nuvigil will harm an unborn baby. Nuvigil has been reported to be associated with growth restriction (small fetus) and miscarriage. Tell your doctor if you are pregnant or plan to become pregnant. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not work while you take Nuvigil. Women who use one of these methods of birth control may have a higher chance of getting pregnant while taking Nuvigil and for 1 month after stopping. Use effective birth control while taking Nuvigil and for 1 month after your final dose. Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

There is a registry for women who become pregnant during treatment with Nuvigil. The purpose of this registry is to collect information about the safety of Nuvigil during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106.

Breastfeeding

It is not known whether Nuvigil passes into breast milk or if it could affect the nursing baby. Talk to
your doctor about the best way to feed your baby if you take Nuvigil.

How should I take Nuvigil?

Take Nuvigil exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Ask your doctor or pharmacist if you have any questions.

Nuvigil is usually taken 1 time a day.

• Nuvigil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.
• You may take this medicine with or without food.
• Do not change the time of day you take Nuvigil unless you have talked to your doctor. If you take Nuvigil too close to your bedtime, you may find it harder to go to sleep.
• Nuvigil is usually given for up to 12 weeks. Follow your doctor’s instructions.

Nuvigil may be habit-forming. Never share Nuvigil with another person, especially someone with a history of drug abuse or addiction. Selling or giving away this medicine is against the law because Nuvigil is a federally controlled substance.

• Keep track of the amount of medicine used from each new bottle. Nuvigil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Nuvigil for OSA

When Nuvigil is used for people with OSA it is usually prescribed with other medications and a CPAP machine.

• A CPAP (continuous positive airway pressure) machine is an air pump connected to the mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
• When you start Nuvigil, do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and Nuvigil may be necessary to best treat your condition.
• Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking this medicine.
• Nuvigil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Nuvigil dosage

Adult Dosage for OSA or Narcolepsy: Nuvigil 150 mg to 250 mg once a day in the morning

Adult Dosage for Shift Work Disorder (SWD): Nuvigil 150 mg once a day, taken approximately one hour before starting your work shift. 

• Liver disease: Reduce the dose of Nuvigil in patients with severe liver disease.
• Geriatric patients: consider a lower dose of Nuvigil.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours.

• If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of Nuvigil. 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 .

Symptoms of an overdose of Nuvigil may include:

• Trouble sleeping
• Confusion
• Feeling excited
• Nausea and diarrhea
• Chest pain
• Anxiety
• Restlessness
• Feeling disoriented
• Hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• A fast or slow heartbeat
• Shortness of breath.

What to avoid

Do not drive a car or do other dangerous activities until you know how Nuvigil affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.

Avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking Nuvigil.

What other drugs will affect Nuvigil?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Nuvigil and many other medicines can interact with each other, sometimes causing side effects. Nuvigil may affect the way other medicines work, and other medicines may affect how it works. Your dose of Nuvigil or certain other medicines may need to be changed.

Especially, tell your doctor if you use or take hormonal birth control, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs).

• Hormonal birth control methods may not work while you take Nuvigil.
• Women who use one of these methods of birth control may have a higher chance of getting pregnant while taking Nuvigil and for 1 month after stopping.
• Use effective birth control while taking Nuvigil and for 1 month after your final dose.
• Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

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

Tell your doctor about all your current medicines and any you start or stop using, especially:

• birth control pills, rings, patches, or other types of hormones
• cyclosporine
• heartburn or antacid medications, such as omeprazole
• seizure medications including phenytoin, diazepam, and others
• antidepressant medications
• blood thinners, such as warfarin (Coumadin, Jantoven)
• beta-blockers, including propranolol, and others.