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• Important Safety Information

IMPORTANT INFORMATION FOR PHYSICIANS

INDICATIONS
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD).

In OSA, 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.

IMPORTANT SAFETY INFORMATION

PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil, armodafinil or its inactive ingredients.

Serious rash, including Stevens Johnson Syndrome (SJS), requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with use of modafinil.

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

In pediatric clinical trials of modafinil, cases of possible SJS and apparent multi-organ hypersensitivity reaction have been reported. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). 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 in adults and children in postmarketing experience with modafinil.

There are no factors, including duration of therapy, that are known to predict the risk of occurrence or the severity of rash. Although benign rashes occur with PROVIGIL, it is not possible to reliably predict which rashes will prove to be serious. PROVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

Cases of angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) were observed among patients treated 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 one 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. Although PROVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. 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, suicidal ideation and aggression, 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, the most commonly reported adverse events ((≥5%) were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. Most adverse experiences were rated as mild to moderate.

PROVIGIL is a Schedule IV controlled substance because it has the potential to be abused or lead to dependence. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Physicians should be aware and inform their patients of the availability of a Medication Guide for PROVIGIL.

Please see Full Prescribing Information for PROVIGIL.

A pregnancy registry has been established to collect information on the pregnancy outcomes of women exposed to PROVIGIL. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-866-404-4106.
For more information about the PROVIGIL pregnancy registry, please visit www.PROVIGILpregnancyregistry.com.

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