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Important Safety Information for PROVIGIL

PROVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder (SWSD), or narcolepsy.

In patients with OSA, PROVIGIL is used along with other medical treatments for this sleep disorder. PROVIGIL is not a replacement for your current treatment. Consult your doctor about the importance of continuing your current OSA treatment while taking PROVIGIL.

PROVIGIL may cause you to have a serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening. If you develop a rash, hives, sores, swelling, or trouble swallowing or breathing, stop taking PROVIGIL and call your doctor right away or get emergency treatment.

PROVIGIL is not approved for use in children.

If you experience chest pain, depression, anxiety, hallucinations, psychosis, mania, thoughts of suicide, aggression, or other mental problems, stop taking PROVIGIL and call your doctor right away or get emergency treatment.

PROVIGIL does not replace sleep and may not stop your ES completely. Do not drive or do other dangerous activities until you know how PROVIGIL affects you. Avoid drinking alcohol while taking PROVIGIL.

PROVIGIL has the potential to be abused or lead to dependence. Please use only as directed.

Tell your doctor if you have: history of mental health problems (including psychosis), heart problems or had a heart attack, high blood pressure, liver or kidney problems, a history of drug or alcohol abuse or addiction, or are pregnant, planning to become pregnant, or breastfeeding.

Women who use hormonal birth control may have a higher chance of getting pregnant, while taking PROVIGIL, and for one month after stopping. Talk to your doctor about other birth control methods while taking PROVIGIL.

Common side effects of PROVIGIL are headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness, and upset stomach.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information, ask your doctor, or call 1-800-896-5855.

This information does not take the place of talking with your doctor about your condition or treatment.

Please see the Patient Information in the Full Prescribing Information for PROVIGIL.