Provigil

Provigil is a prescription medicine used to treat adults with certain sleep disorders including narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Provigil is in a class of drugs known as central nervous system (CNS) stimulants, which alter brain activity to promote wakefulness.

Provigil is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

• narcolepsy
• obstructive sleep apnea (OSA). Provigil is used with other medical treatments for this sleep disorder.
• shift work disorder (SWD)


This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cephalon, Inc.

Provigil may cause serious side effects. Stop taking Provigil and call your doctor right away or get emergency help if you get any of the following:

• a serious rash or serious allergic reaction
• psychiatric (mental) symptoms, including:
  • depression
  • feeling anxious
  • hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
  • an extreme increase in activity and talking (mania)
  • thoughts of suicide aggressive behavior
  • other mental problems
• symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing

Common side effects include:

• back pain
• headache
• nausea
• feeling nervous
• stuffy nose
• diarrhea
• feeling anxious
• dizziness
• upset stomach
• trouble sleeping


Tell your doctor if you get any side effect that bothers you or that does not go away while taking. Some effects of Provigil on the brain are the same as other medicines called “stimulants”. These effects may lead to abuse or dependence on Provigil.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Provigil and many other medicines can interact with each other, sometimes causing side effects. Provigil may affect the way other medicines work, and other medicines may affect how Provigil works. Your dose of Provigil or certain other medicines may need to be changed. Especially, tell your doctor if you use or take a hormonal birth control method such as:

• birth control pills
• shots
• implant
• patches
• vaginal rings
• intrauterine devices (IUDs)

Hormonal birth control methods may not work while you take Provigil. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking Provigil. This risk lasts for one month after stopping Provigil. Talk to your doctor about birth control choices that are right for you while taking Provigil.

Do not drive a car or do other dangerous activities until you know how Provigil 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.

You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking Provigil.

Do not take Provigil if you:

• are allergic to any of its ingredients.
• have had a rash or allergic reaction to either modafinil (Provigil) or armodafinil (Nuvigil). These medicines are very similar.

Grapefruit and grapefruit juice may interact with Provigil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor about all of your medical conditions including, if you:

• have a history of mental health problems, including psychosis
• have heart problems or had a heart attack
• have high blood pressure. Your blood pressure may need to be checked more often while taking Provigil.
• have liver or kidney problems
• have a history of drug or alcohol abuse or addiction
• are pregnant or planning to become pregnant. It is not known if Provigil will harm your unborn baby.
• are breastfeeding. It is not known if Provigil passes into your milk. Talk to your doctor about the best way to feed your baby if you take Provigil.


Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Provigil will harm your unborn baby. Provigil has not been studied in pregnant women. Provigil should be used during pregnancy only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Provigil is excreted in human breast milk or if it will harm your nursing baby.

• Take Provigil exactly as prescribed by your doctor. Your doctor will prescribe the dose of Provigil that is right for you. Do not change your dose of Provigil without talking to your doctor.
• Your doctor will tell you the right time of day to take Provigil.
• People with narcolepsy or obstructive sleep apnea (OSA) usually take Provigil one time each day in the morning.
• People with shift work disorder (SWD) usually take Provigil about 1 hour before their work shift.
• Do not change the time of day you take Provigil unless you have talked to your doctor. If you take Provigil too close to your bedtime, you may find it harder to go to sleep.
• You can take Provigil with or without food.

Take Provigil exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Provigil must be individualized.

The recommended dose of Provigil is 200 mg given once a day.

For patients with narcolepsy and obstructive sleep apnea (OSA), Provigil should be taken as a single dose in the morning.

For patients with shift work disorder (SWD), Provigil should be taken approximately 1 hour prior to the start of their work shift.

If you take more than your prescribed dose or if you take an overdose of Provigil, call your doctor or poison control center right away.
 Symptoms of an overdose of Provigil may include:

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

• Store Provigil at room temperature between 68° and 77° F (20° and 25° C).
• Keep Provigil and all medicines out of the reach of children.