Nuvigil Patient Information

Brand Name: Nuvigil, Provigil
Generic Name: armodafinil

Nuvigil, full prescribing information

What is Nuvigil?

Nuvigil is a medication that promotes wakefulness.

Nuvigil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Nuvigil may also be used for purposes other than those listed in this medication guide.

Important information about Nuvigil

You should not use this medication if you are allergic to armodafanil or modafanil (Provigil).

Before using Nuvigil, tell your doctor if you have angina (chest pain), liver or kidney disease, a heart problem, a history of drug addiction, if you take blood pressure medication, or if you have recently had a heart attack.

Nuvigil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Stop taking Nuvigil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to Nuvigil has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash.

There may be other drugs that can interact with Nuvigil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Before taking Nuvigil

You should not use this medication if you are allergic to armodafanil or modafanil (Provigil).

Before using Nuvigil, tell your doctor if you are allergic to any drugs, or if you have:

• angina (chest pain);
• cirrhosis or other liver problem;
• kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• a history of drug addiction;
• if you take blood pressure medications; or
• if you have recently had a heart attack.

If you have any of these conditions, you may not be able to use Nuvigil, or you may need dosage adjustments or special tests during treatment.

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to Nuvigil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking Nuvigil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Nuvigil can make certain types of birth control pills less effective, which could result in an unplanned pregnancy. Talk with your doctor about the best methods of birth control to use while taking Nuvigil. It is not known whether Nuvigil 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. Do not give Nuvigil to anyone younger than 17 years old.

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How should I take Nuvigil?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Nuvigil is usually given for 12 weeks or less. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

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.

If you are taking Nuvigil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to 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.

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.

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.

Talk with your doctor if you continue to have excessive sleepiness even while taking Nuvigil.

Taking this medication does not take the place of getting enough sleep.

Store Nuvigil at room temperature away from moisture and heat.

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 if you think you have used too much of this medicine.

Overdose symptoms may include feeling excited or agitated, confusion, trouble sleeping, nausea, or diarrhea.

What should I avoid while taking Nuvigil?

Nuvigil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking Nuvigil.

Nuvigil side effects

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. Stop using Nuvigil and call your doctor at once if you have any of these serious side effects:

• fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
• bruising, severe tingling, numbness, pain, muscle weakness;
• easy bruising or bleeding;
• white patches or sores inside your mouth or on your lips;
• hallucinations, unusual thoughts or behavior;
• depression, anxiety; or
• chest pain, uneven heart beats.

Less serious Nuvigil side effects may include:

• headache, dizziness;
• feeling nervous or agitated;
• nausea, diarrhea;
• trouble sleeping (insomnia); or
• dry mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Nuvigil?

Before using Nuvigil, tell your doctor if you are using any of the following drugs:

• cyclosporine (Neoral, Sandimmune, Gengraf);
• propranolol (Inderal);
• omeprazole (Prilosec);
• rifampin (Rifadin, Rimactane, Rifater);
• a sedative such as diazepam (Valium), midazolam (Versed), or triazolam (Halcion);
• seizure medication such as carbamazepine (Carbatrol, Tegretol) or phenobarbital (Luminal, Solfoton);
• an antidepressant such as clomipramine (Anafranil), isocarboxazid (Marplan), or phenelzine (Nardil); or
• an antibiotics such as erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin) or ketoconazole (Nizoral).

This list is not complete and there may be other drugs that can interact with Nuvigil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Nuvigil.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

last updated 02/2010

Nuvigil, full prescribing information

Detailed Info on Signs, Symptoms, Causes, Treatments of Sleep Disorders

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