FAQs

What is NUVIGIL indicated to treat?

NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction.¹

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How has the effectiveness of NUVIGIL been shown?

NUVIGIL has been studied in 4 pivotal trials.¹
Click here for more information

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What important information should I know before prescribing NUVIGIL?

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 in adults 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.

Who should not take NUVIGIL?

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

Patients who have had a rash or allergic reaction to NUVIGIL or modafinil, or are allergic to any of the following ingredients: modafinil, armodafinil, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, or pregelatinized starch.

Patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome.

Pregnancy/Birth control:

NUVIGIL is Pregnancy Category C.

Make sure to ask female patients if they use a hormonal birth control method. NUVIGIL can affect hormonal birth control methods, including pills, shots, implants, patches, vaginal rings, and hormone-releasing intrauterine devices.

Women who use hormonal birth control may have a higher chance of getting pregnant while taking NUVIGIL, and for one month after stopping. Talk to your patients about other birth control methods while taking NUVIGIL.

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How is NUVIGIL different than modafinil?

NUVIGIL (R-modafinil) is the longer-lasting isomer of modafinil. Modafinil is 50% R-modafinil and 50% the shorter-lasting isomer S-modafinil.²

NUVIGIL stays in the blood longer than modafinil because it contains mostly R-modafinil.³ However, the amount of medicine in the blood does not necessarily reflect how well the medicine works.

There are no clinical studies comparing the efficacy of NUVIGIL and modafinil.

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Is NUVIGIL a stimulant?

The chemical structure of NUVIGIL is different from classical stimulants like amphetamines and methylphenidate. While the exact mechanism of action is unknown, NUVIGIL is believed to work in the central nervous system in a similar way.¹

As with classical stimulants, some effects of NUVIGIL on the brain may lead to abuse of or dependence on NUVIGIL. Before prescribing NUVIGIL, ask your patient if he or she has ever abused drugs, including stimulant medicines.¹

NUVIGIL is a federally controlled substance (C-IV) because it has the potential to be abused or lead to dependence. Please use NUVIGIL only as directed and keep in a safe place to prevent misuse and abuse.¹

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What are common adverse reactions to NUVIGIL?

In clinical trials, the most frequently reported adverse events (≥5%) were headache, nausea, dizziness, and insomnia.¹

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Can I request more information and/or a visit from a NUVIGIL sales representative?

Cephalon is pleased to offer a variety of materials to help you and your patients.

Click here to visit the NUVIGIL Resource Center to request additional materials about NUVIGIL and OSA, SWD, and narcolepsy. You can also request a visit from a sales representative.

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Are there free samples, copay cards, or other money-saving offers available for my patients?

Cephalon is pleased to offer a variety of materials to help you and your patients.

Click here to visit the NUVIGIL Resource Center for a FREE Starter Voucher and information on the NUVIGIL Prescription Savings Program.

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IMPORTANT INFORMATION FOR PHYSICIANS

INDICATIONS

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

In OSA, NUVIGIL 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 NUVIGIL. Careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is important.

IMPORTANT SAFETY INFORMATION

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.