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 not listed in this medication guide.

You should not use Nuvigil if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking Nuvigil and call your doctor if you have a skin rash, no matter how mild. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

Before using Nuvigil, tell your doctor if you have liver or kidney disease, heart disease or high blood pressure, a heart valve disorder, a history of mental illness, a history of drug or alcohol addiction, or if you have recently had a heart attack.

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.

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.

Read all patient information, medication guides, and instruction sheets provided to you. 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.

You may take this medicine with or without food.

Nuvigil is usually given for up to 12 weeks. Follow your doctor's instructions.

If you are taking this medicine 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.

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.

Store at room temperature away from moisture and heat.

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.

You should not use Nuvigil if you are allergic to armodafinil or modafinil (Provigil).

To make sure Nuvigil is safe for you, tell your doctor 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; or

• drug or alcohol addiction.

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) will not effectively prevent pregnancy while you are taking Nuvigil.

It is not known whether Nuvigil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Nuvigil is not approved for use by anyone younger than 17 years old.

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.

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

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

Nuvigil 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.

Get emergency medical help if you have signs of an allergic reaction to Nuvigil: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

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

• skin rash;

• fever, swollen glands, flu-like symptoms;

• unusual bruising or jaundice (yellowing of your skin or eyes);

• severe tingling, numbness, pain, muscle weakness;

• unusual bleeding (nosebleeds, bleeding gums);

• skin sores or blistering;

• mouth sores, trouble swallowing;

• chest pain, uneven heart beats; or

• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts; or

• excessive sleepiness

Common Nuvigil side effects may include:

• headache, dizziness;

• nausea; or

• sleep problems (insomnia).

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.

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:

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

• 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); or

• beta-blockers, including propranolol, others.

This list is not all inclusive.

Other drugs may interact with Nuvigil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.