REDISCOVER WAKEFULNESS
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NUVIGIL improves wakefulness throughout the day or shift in patients with excessive sleepiness associated with treated OSA, SWD, and narcolepsy1

NUVIGIL has been studied in 4 pivotal trials.1

Studied in 1108 patients1

  • In four 12-week, double-blind, randomized, placebo-controlled trials
  • In patients with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy

Primary efficacy measures

The primary efficacy measures in the pivotal trials for NUVIGIL were the Maintenance of Wakefulness Test (MWT) or Multiple Sleep Latency Test (MSLT), and the Clinical Global Impression of Change (CGI-C).2,3

MWT4,5

An objective physiologic assessment of sleepiness that measures a subject's ability to sustain wakefulness.

  • In the OSA and narcolepsy studies, a coprimary endpoint was the average of 4 MWT sessions from 9 am to 3 pm
  • In the clinical studies of NUVIGIL, patients were instructed to try to remain awake in a darkened room while in a semireclined position during a series of 30-minute (for the OSA studies) or 20-minute (for the narcolepsy study) periods at scheduled times
  • Sleep latency was defined as:
    • 3 consecutive 30-second epochs of stage 1 sleep were reached, or
    • Any single 30-second epoch of stage 2, 3, 4, or REM sleep was reached
  • Epochs were individually scored using the 50% (or 16-second) rule
    • If patients fell asleep, they were awakened immediately but were required to stay in bed, and they were prevented from falling asleep again for the remainder of the test session

MSLT4-7

An objective assessment of sleepiness that measures the likelihood of falling asleep.

  • In the SWD study, a coprimary endpoint was the average of 4 MSLT sessions from 2 am to 8 am
  • In the clinical study for NUVIGIL conducted in patients with SWD, five 20-minute (maximum) MSLT naps were performed at scheduled 2-hour intervals
  • The patient was instructed to lie quietly and attempt to sleep. Each MSLT nap continued until:
    • 3 consecutive 30-second epochs of stage 1 sleep were reached, or
    • Any single 30-second epoch of stage 2, 3, 4, or REM sleep was reached
  • Sleep latency was defined as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch. Each nap was terminated after 20 minutes if no sleep occurred. If patients fell asleep, they were awakened and kept awake while remaining in bed

CGI-C

A standard assessment tool used to measure the impact of symptoms or disease on a patient's overall clinical condition, as well as changes in response to treatment. Change in overall condition is assessed using the CGI-C, a 7-point scale that ranges from Very Much Improved to Very Much Worse.

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.

 

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References: 1. NUVIGIL [package insert]. Frazer, PA: Cephalon, Inc; 2010. 2. Roth T, White D, Schmidt-Nowara W, et al. Effects of armodafinil in the treatment of residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome: a 12-week, multicenter, double-blind, randomized, placebo-controlled study in nCPAP-adherent adults. Clin Ther. 2006;28(5):689-706. 3. Harsh JR, Hayduk R, Rosenberg R, et al. The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy. Curr Med Res Opin. 2006;22(4):761-774. 4. Data on file. Cephalon, Inc. 5. Littner MR, Kushida C, Wise M, et al. Practice parameters for clinical use of the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test. Sleep. 2005;28(1):113-121. 6. Hirshkowitz M, Black JE, Wesnes K, Niebler G, Arora S, Roth T. Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome. Respir Med. 2007;101(3):616-627. 7. Czeisler CA, Walsh JK, Wesnes KA, Arora S, Roth T. Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study. Mayo Clin Proc. 2009;84(11):958-972.

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