INDICATIONS

PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.

In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice, the encouragement of and periodic assessment of CPAP compliance is necessary and a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. Careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is important. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

IMPORTANT INFORMATION FOR PHYSICIANS

Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with use of modafinil. In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients; these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities. No serious skin rashes have been reported in adult clinical trials of modafinil. Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported, postmarketing, in adults and children taking modafinil. PROVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

Modafinil is not approved for use in pediatric patients for any indication.

One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm) were observed among patients treated with armodafinil, the R-enantiomer of modafinil. Angioedema has been reported in postmarketing experience with modafinil. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis.

Multi-organ hypersensitivity reactions, including at least 1 fatality postmarketing, have occurred in close temporal association to the initiation of modafinil. If a multi-organ hypersensitivity reaction is suspected, PROVIGIL should be discontinued.

Patients should be advised that their level of wakefulness may not return to normal. Patients should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events have included mania, delusions, hallucinations, and suicidal ideation, some resulting in hospitalization. In controlled trials in adults, psychiatric symptoms resulting in treatment discontinuation were anxiety, nervousness, insomnia, confusion, agitation, and depression. Caution should be exercised when PROVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing PROVIGIL if psychiatric symptoms develop.

Patients with a recent history of myocardial infarction or unstable angina should be treated with caution. PROVIGIL tablets should not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. There were also a greater proportion of patients on PROVIGIL requiring new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of blood pressure may be appropriate in patients on PROVIGIL.

PROVIGIL may interact with drugs that inhibit, induce, or are metabolized by cytochrome P450 isoenzymes.

The effectiveness of steroidal contraceptives may be reduced when used with PROVIGIL tablets and for one month after discontinuation of therapy.

The concomitant use of PROVIGIL and alcohol has not been studied and should be avoided.

In clinical trials, most adverse experiences were mild to moderate. The most frequently reported adverse events (≥5%) were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.

PROVIGIL is a Schedule IV drug. PROVIGIL produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Please see Full Prescribing Information for PROVIGIL.