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

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

NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

In pediatric clinical trials of modafinil, a racemic mixture of S- and R-modafinil (the latter is armodafinil), cases of serious rash including 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.

No serious skin rashes were reported in adult clinical trials of armodafinil. However, cases of serious rash similar to those observed with modafinil including skin and mouth blistering have been reported in adults in postmarketing experience.

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 NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL 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 NUVIGIL. Multi-organ hypersensitivity reactions, including at least one fatality postmarketing, have occurred in close temporal association to the initiation of modafinil. Patients should be advised to discontinue NUVIGIL and immediately report to their physician any signs or symptoms suggesting multi-organ hypersensitivity, angioedema or anaphylaxis.

Patients should be advised that their level of wakefulness may not return to normal. Although NUVIGIL 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 functional impairment 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 associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.

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

NUVIGIL 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 NUVIGIL and for one month after discontinuation of therapy. The concomitant use of NUVIGIL and alcohol has not been studied and should be avoided.

In clinical trials, the most commonly reported adverse events (≥5%) were headache, nausea, dizziness, and insomnia. Most adverse experiences were rated as mild to moderate.

NUVIGIL 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 NUVIGIL.

Please see Full Prescribing Information for NUVIGIL.

There is a registry for women who become pregnant during treatment with NUVIGIL. The purpose of this registry is to collect information about the safety of NUVIGIL during pregnancy. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106 or by visiting www.NUVIGILpregnancyregistry.com.