INDICATIONS AND USAGE

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

Limitations of Use
In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness.

*Limitations apply.

NUVIGIL INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

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

Limitations of Use
In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with NUVIGIL for excessive sleepiness.

IMPORTANT SAFETY INFORMATION


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

Serious rash: Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in association with the use of NUVIGIL or 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 also occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related.

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

Angioedema and hypersensitivity reactions: Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) were observed in patients with NUVIGIL. Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, 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 angioedema or anaphylaxis, or multi-organ hypersensitivity.

Psychiatric symptoms: Psychiatric adverse experiences have been reported in patients treated with NUVIGIL and modafinil. In controlled trials in adults treated with NUVIGIL, psychiatric symptoms resulting in treatment discontinuation included anxiety, agitation, nervousness, irritability, and depression. Postmarketing adverse reactions associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation, and aggression, some resulting in hospitalization. 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.

Persistent sleepiness and CNS effects: 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.

Cardiovascular events: Cardiovascular adverse reactions have been reported in patients treated with modafinil in association with mitral valve prolapse or left ventricular hypertrophy. NUVIGIL is not recommended 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. If findings of mitral valve prolapse syndrome occur, consider cardiac evaluation. In clinical studies, a greater proportion of patients on NUVIGIL required new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of heart rate and blood pressure may be appropriate in patients on NUVIGIL. Caution should be exercised when prescribing NUVIGIL to patients with known cardiovascular disease.

Drug interactions: NUVIGIL may interact with drugs that are substrates for CYP3A4/5 or CYP2C19. Dose adjustment of these drugs may be required. The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy.

Common adverse reactions: In clinical trials, the most commonly reported adverse reactions (≥5%) associated with the use of NUVIGIL were headache, nausea, dizziness, and insomnia

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 the Medication Guide for NUVIGIL.

Please see Full Prescribing Information for NUVIGIL.

IMPORTANT SAFETY INFORMATION

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

Serious rash: Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in association with the use of 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 also 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.

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

Angioedema and hypersensitivity reactions: Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) were observed in patients treated with armodafinil. Angioedema has been reported in postmarketing experience with modafinil. Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil. Patients should be advised to discontinue PROVIGIL and immediately report to their physician any signs or symptoms suggesting multi-organ hypersensitivity, angioedema or anaphylaxis.

Psychiatric symptoms: Psychiatric adverse experiences have been reported in patients treated with modafinil. In controlled trials in adults treated with PROVIGIL, psychiatric symptoms resulting in treatment discontinuation included anxiety, nervousness, insomnia, confusion, agitation, and depression. Postmarketing adverse reactions associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation, and aggression, some resulting in hospitalization. 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.

Persistent sleepiness and CNS effects: 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 functional impairment and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Cardiovascular effects: Cardiovascular adverse reactions have been reported in patients treated with modafinil in association with mitral valve prolapse or left ventricular hypertrophy. PROVIGIL is not recommended 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. If findings of mitral valve prolapse syndrome occur, consider cardiac evaluation. Consider increased monitoring in patients with a recent history of myocardial infarction or unstable angina. In clinical studies, a greater proportion of patients on PROVIGIL required new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of heart rate and blood pressure may be appropriate in patients on PROVIGIL. Caution should be exercised when prescribing PROVIGIL to patients with known cardiovascular disease.

Drug interactions: PROVIGIL may interact with drugs that are substrates for CYP3A4/5 or CYP2C19. Dose adjustment of these drugs may be required. The effectiveness of steroidal contraceptives may be reduced when used with PROVIGIL and for one month after discontinuation of therapy.

Common adverse reactions: In clinical trials, the most commonly reported adverse reactions (≥5%) associated with the use of PROVIGIL were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.

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 the Medication Guide for PROVIGIL.

Please see Full Prescribing Information for PROVIGIL.