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Narcolepsy is a chronic neurologic disorder

All patients with narcolepsy suffer from excessive sleepiness (ES).1,2

Narcolepsy is characterized by ES, a profoundly disabling symptom and usually the first to present. Patients with narcolepsy experience repeated episodes of unintended naps or short lapses into sleep during the daytime. ES frequently recurs within a few hours after waking, and the episodes are repeated throughout the day.1

Narcolepsy with cataplexy is rare and is estimated to affect approximately 0.02% to 0.18% of Americans and Western Europeans.2 More than 80% of cases of narcolepsy with cataplexy are fully developed by the time patients reach 40 years of age.3

Sleepiness in narcolepsy is believed to result from disrupted neural circuitry.4

Narcolepsy stems from an instability between sleeping and waking states. Most cases of narcolepsy are caused by the brain’s autoimmune destruction of orexin-producing neurons, which are believed to stabilize sharp transitions between sleeping and waking states.4,5

Narcolepsy takes different forms, but each is characterized by ES.1,2,6

Diagnostic criteria distinguish 3 categories of narcolepsy: narcolepsy with cataplexy, narcolepsy without cataplexy, and narcolepsy due to another underlying medical condition.2,6 ES is a common symptom of narcolepsy and present in each subtype of the disorder, whereas cataplexy is an uncommon symptom.1,6 A diagnosis of narcolepsy with cataplexy requires that the patient has a documented history of cataplexy.1,2,6

Narcolepsy without cataplexy is defined by the absence of cataplexy and the presence of sleep paralysis and hypnagogic hallucinations. In addition, it requires a positive/abnormal Multiple Sleep Latency Test (mean sleep latency <8 minutes) and ≥2 sleep-onset rapid eye movement (REM) periods.5,6

There are diagnostic criteria for narcolepsy.


ICSD-II Diagnostic Criteria for Narcolepsy

Narcolepsy With Cataplexy

  1. The patient has a complaint of excessive daytime sleepiness occurring almost daily for at least three months.

  2. A definite history of cataplexy, defined as sudden and transient episodes of loss of muscle tone triggered by emotions, is present.

  3. The diagnosis of narcolepsy with cataplexy should, whenever possible, be confirmed by nocturnal polysomnography followed by an MSLT; the mean sleep latency on MSLT is less than or equal to eight minutes and two or more SOREMPs are observed following sufficient nocturnal sleep (minimum six hours) during the night prior to the test. Alternatively, hypocretin-1 levels in the CSF are less than or equal to 110 pg/mL or one third of mean normal control values.

  4. The hypersomnia is not better explained by another sleep disorder, medical or neurological disorder, mental disorder, medication use, or substance use disorder.

Narcolepsy Without Cataplexy

  1. The patient has a complaint of excessive daytime sleepiness occurring almost daily for at least three months.

  2. Typical cataplexy is not present, although doubtful or atypical cataplexy-like episodes may be reported.

  3. The diagnosis of narcolepsy without cataplexy must be confirmed by nocturnal polysomnography followed by an MSLT. In narcolepsy without cataplexy, the mean sleep latency on MSLT is less than or equal to eight minutes and two or more SOREMPs are observed following sufficient nocturnal sleep (minimum six hours) during the night prior to the test.

  4. The hypersomnia is not better explained by another sleep disorder, medical or neurological disorder, mental disorder, medication use, or substance use disorder.

ES is a prominent symptom of narcolepsy, and it can be treated.1,2,7

There is no cure for narcolepsy, but making lifestyle or behavioral changes can help manage symptoms of the disorder. For example, patients may take scheduled naps during the day to prevent falling asleep unexpectedly. Medications are also available to treat ES associated with narcolepsy.7,8

NUVIGIL® (armodafinil) Tablets [C-IV] has been shown to improve wakefulness throughout the day for people suffering from ES associated with narcolepsy.8

Click here to learn more about Significant Improvements in Patients With Narcolepsy.

While NUVIGIL is indicated to treat ES associated with narcolepsy, it is not indicated to treat narcolepsy itself or its other associated symptoms and sequelae.

Also of interest:

For patient assessment, download the Epworth Sleepiness Scale.

Could snoring be something more serious? Download the STOP Screener, the OSA patient screener.


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. American Academy of Sleep Medicine. The International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005. 2. Longstreth WT Jr, Koepsell TD, Ton TG, Hendrickson AF, van Belle G. The epidemiology of narcolepsy. Sleep. 2007;30(1):13-26. 3. Mignot E, Lin L, Finn L, et al. Correlates of sleep-onset REM periods during the Multiple Sleep Latency Test in community adults. Brain. 2006;129 (Pt 6):1609-1623. 4. Saper CB, Scammell TE, Lu J. Hypothalamic regulation of sleep and circadian rhythms. Nature. 2005;437(7063):1257-1263. 5. Mignot E. Narcolepsy: pharmacology, pathophysiology, and genetics. In: Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. 4th ed. Philadelphia, PA: Elsevier Saunders; 2005:761-779. 6. Thorpy MJ. Classification of sleep disorders. In: Kryger MH, Roth T, Demont WC, eds. Principles and Practice of Sleep Medicine. 4th ed. Philadelphia, PA: Elsevier Saunders; 2005:615-625. 7. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed, text revision. Washington, DC: American Psychiatric Association; 2000. 8. NUVIGIL [package insert]. Frazer, PA: Cephalon, Inc; 2010.

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