What is narcolepsy?1

Narcolepsy is a sleep disorder involving the brain. Narcolepsy occurs when the brain cannot normally regulate cycles of sleep and waking. This can cause daytime excessive sleepiness (ES) that results in episodes of falling asleep suddenly.2

  • It is estimated that narcolepsy affects 1 in every 2000 Americans2

What causes narcolepsy?

The cause of narcolepsy is not known. Sometimes the body's immune system mistakenly attacks the brain cells involved in regulating the sleep-wake cycle. It is believed that narcolepsy is the result of these cells being damaged or destroyed.

Why is narcolepsy a problem?

Because the daytime sleep episodes associated with narcolepsy can occur at any time during the day, narcolepsy is very disabling and has a profound effect on the social and work lives of people with the disorder.1

  • Narcolepsy can threaten safety, as patients may fall asleep while performing various activities1
  • People with narcolepsy often fall asleep several times a day, while at work or school, or even during a conversation or meal1,2

Talk to your doctor about whether you should avoid driving or using heavy machinery while taking NUVIGIL® (armodafinil) Tablets [C-IV].

While NUVIGIL is used to improve wakefulness in patients with with narcolepsy, it is not used to treat narcolepsy itself or its other symptoms or consequences.

References: 1. National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health Web site. http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm. Accessed May 11, 2009. 2. American Academy of Sleep Medicine. International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005.

Important Safety Information

What is NUVIGIL?

NUVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder, or narcolepsy.

In patients with OSA, NUVIGIL is used along with other medical treatments for this sleep disorder. NUVIGIL is not a replacement for your current treatment. Consult your doctor about the importance of continuing your current OSA treatment while taking NUVIGIL.

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.

What important information should I know about NUVIGIL?

  • NUVIGIL may cause you to have a serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening.
  • If you develop a rash, hives, sores, swelling, or trouble swallowing or breathing, stop taking NUVIGIL and call your doctor right away or get emergency treatment.

Who should not take NUVIGIL?

  • NUVIGIL has not been studied in children under the age of 17. NUVIGIL is not approved for children for any condition.
  • Anyone who has had a rash or allergic reaction to NUVIGIL or PROVIGIL® (modafinil) Tablets [C-IV], or is allergic to any of the following ingredients: modafinil, armodafinil, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, or pregelatinized starch.
  • Anyone with mitral valve prolapse who has experienced mitral valve prolapse syndrome.

What are possible side effects of NUVIGIL?

  • Common side effects of NUVIGIL are headache, nausea, dizziness, and trouble sleeping.
  • If you experience chest pain, depression, anxiety, hallucinations, psychosis, mania, thoughts of suicide, aggression, or other mental problems, stop taking NUVIGIL and call your doctor right away or get emergency treatment.
  • For more information about other side effects, ask your doctor or pharmacist.

What should I avoid while taking NUVIGIL?

  • Do not drive a car or do other dangerous activities until you and your doctor know how NUVIGIL affects you.
  • Avoid drinking alcohol.

What should I tell my doctor before starting NUVIGIL?

  • Tell your doctor about all of your health conditions including if you have: history of mental health problems (including psychosis), heart problems or had a heart attack, high blood pressure, liver or kidney problems, a history of drug or alcohol abuse or addiction, or are pregnant, planning to become pregnant, or breastfeeding.
  • 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 doctor about other birth control methods while taking NUVIGIL.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or by fax at 1-800-FDA-0178.

For more information, ask your doctor or call 1-800-896-5855.

This information does not take the place of talking with your doctor about your condition or treatment.

Please see the Patient Information in the full prescribing information for NUVIGIL.