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Provigil®

Brand Name: Provigil®
Active Ingredient:   modafinil
Strength(s): 100mg and 200mg
Dosage Form(s):   Tablets
Company Name:    Cephalon, Inc.
Availability:         Prescription only, Schedule IV Controlled Substance
*Date Approved by the FDA:   December 24, 1998
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Provigil used for?

Provigil is used to improve wakefulness in people with excessive daytime sleepiness associated with narcolepsy.

General Precautions with Provigil:

  • Provigil can decrease the effectiveness of certain contraceptives including birth control pills, and implantable contraceptives. If you are using this type of contraceptive while taking Provigil and for 1 month after you stop treatment with Provigil you should either:
    • use an alternate birth control method, or
    • use another effective birth control method together with your current contraceptive.
  • Doses of your other medications may need to be adjusted or you may have to be monitored more closely.
  • Do not drive or operate other complex machinery until you know how Provigil affects your ability to function.
  • Avoid alcohol.
  • Call your health care provider if you develop a skin rash, hives, or allergic reactions.

What should I tell my doctor or health care provider?

Tell your doctor or health care provider if you:

  • have any heart conditions, (including valve problems, irregular heart beat, recent heart attack, or unstable chest pain)
  • have a history of mental illness
  • have liver problems
  • you are trying to become pregnant, are already pregnant, or are breast-feeding.
  • Review all medications that you are taking with your health care provider, including those that you take without a prescription, because certain other medications can interact with Provigil.

What are some possible side effects of Provigil? (This is NOT a complete list of side effects reported with Provigil. Your health care provider can discuss with you a more complete list of side effects.)  

  • Headache
  • Infection
  • Nausea
  • Nervousness
  • Feeling anxious
  • Trouble sleeping

For more detailed information about Provigil, ask your health care provider.

http://www.fda.gov/cder/foi/label/1998/20717lbl.pdf    Link to Provigil's Labeling

Date Posted: 2/23/99
Revised: 11/16/00

Back to Drug Side Effects


source: FDA


last update: December 2004





This information is not intended to be a substitute for professional medical advice. You should not use this material to diagnose or treat a health condition or disease without consulting with your healthcare provider.
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