Provigil is a medication that promotes wakefulness. It is thought to work by altering the natural chemicals (neurotransmitters) in the brain.

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

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

You should not use Provigil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).

Provigil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have a skin rash or hives, blisters or peeling, mouth sores, trouble breathing or swallowing, fever, swelling in your legs, dark urine, yellowing of your skin or eyes, or swelling in your face.

Before using Provigil, 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.

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

Take Provigil 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.

Modafinil may be habit-forming. Never share Provigil with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Provigil 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.

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

You may take the tablet with or without food.

Provigil is usually given for 12 weeks or less.

If you are taking Provigil 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 a 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 Provigil may be necessary to best treat your condition.

Provigil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.

Call your doctor if you continue to have excessive sleepiness even while taking this medicine.

Taking Provigil does not take the place of getting enough sleep.

Store at room temperature away from moisture and heat.

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

Usual Adult Dose for Narcolepsy:

200 mg orally daily in the morning

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

200 mg orally daily in the morning

Usual Adult Dose for Shift Work Sleep Disorder:

200 mg orally daily one hour prior to the start of the work shift

Usual Pediatric Dose for Attention Deficit Disorder:

Not FDA approved.
Reports of serious dermatologic adverse effects and psychiatric events has resulted in the FDA's Pediatric Advisory Committee unanimously recommending that a specific warning against the use of modafinil in children be added to the manufacturer's labeling; use only if first- and second-line treatments have failed and the benefits outweigh the risks.
Children less than 30 kg: 200-340 mg once daily
Children more than 30 kg: 300-425 mg

Randomized, double-blind, placebo-controlled pediatric studies have utilized an 85 mg film-coated tablet (currently not commercially available) to provide these dosages. All studies utilized a titration method but varied the length of titration (3 weeks vs 7-9 days); clinical improvement was noted earlier in the shorter titration period.

You should not use Provigil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).

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

• angina (chest pain);

• cirrhosis or other liver problem;

• kidney disease;

• high blood pressure, heart disease, or history of heart attack;

• a history of mental illness or psychosis; or

• history of alcoholism or drug addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Provigil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Talk with your doctor about the best methods of birth control to use while taking Provigil.

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

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

Talk with your doctor about what to do if you miss a dose of Provigil. Avoid taking the medicine if you do not plan to be awake for several hours. Skip the missed dose if it is almost bedtime. 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.

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

Avoid other dangerous activities until you know how Provigil will affect your level of wakefulness.

Avoid drinking alcohol while taking modafinil.

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

Provigil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have:

• skin rash or hives, blisters or peeling;

• mouth sores, trouble swallowing;

• fever, shortness of breath;

• swelling in your legs;

• dark urine, jaundice (yellowing of the skin or eyes); or

• swelling in your face, eyes, lips, tongue, or throat.

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

• depression, anxiety, suicidal thoughts or actions;

• hallucinations, unusual thoughts or behavior, aggression, being more active or talkative than usual;

• chest pain, trouble breathing, uneven heart beats; or

• the first sign of any skin rash, no matter how minor you think it might be.

Common Provigil side effects may include:

• headache, dizziness;

• feeling nervous or anxious;

• back pain;

• nausea, diarrhea, upset stomach;

• sleep problems (insomnia); or

• stuffy nose.

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.

Other drugs may interact with modafinil, 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.