Did you know that PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness (ES) associated with obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder, and narcolepsy?

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. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

*Limitations apply.

NUVIGIL INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

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

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 NUVIGIL for excessive sleepiness. If NUVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. Careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance.

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 ordinarily 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 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 multi-organ hypersensitivity, angioedema or anaphylaxis.

Psychiatric symptoms: Psychiatric adverse experiences have been reported in patients treated with NUVIGIL and modafinil. In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, irritability, and depression. Cases of suicidal ideation, mania, delusions, hallucinations, and aggression, some resulting in hospitalization, have been reported in patients treated with NUVIGIL or modafinil. 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 effects: 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. Small average increases in blood pressure and heart rate were observed in clinical trials. 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 events (≥5%) associated with the use of NUVIGIL were headache, nausea, dizziness, and insomnia.

Drug abuse and dependence: 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 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.