REDISCOVER WAKEFULNESS

Wakefulness and treated obstructive sleep apnea

Can obstructive sleep apnea (OSA) be treated?

Yes, there are a number of ways to treat the blockage in your airway that disrupts your breathing while you sleep and causes OSA.

  • Continuous positive airway pressure (CPAP)—the most common treatment for OSA, uses air pressure to help keep your airway open, so you can breathe better while you sleep
  • Dental devices—can help keep your airway open while you sleep by holding your jaw in a forward position
  • Surgery—may help to correct the blockage

Your doctor may also suggest changing behaviors such as losing weight, avoiding alcohol or certain medicines, or changing your sleeping position. If you haven't already done so, ask your doctor which treatment options may be right for you.1

Are you still sleepy, even with treatment for OSA?

Many people using CPAP for OSA therapy still suffer from excessive sleepiness (ES).2 Are you one of them? It's important to know that even with CPAP, it's still possible for your wakefulness to be impaired.

  • In a clinical study, as many as half of all patients with OSA using CPAP still experienced excessive sleepiness2
    • Researchers used an objective measure of a patient's degree of ES, the Multiple Sleep Latency Test (MSLT), to study people who used their CPAP for at least 6 hours per night

Don't make the mistake of thinking it's normal to live this way. If you experience excessive sleepiness while being treated for OSA, you should tell your doctor how hard it is for you to stay awake and discuss how to improve your wakefulness.

NUVIGIL could improve your wakefulness throughout the day if you are being treated for OSA but are still experiencing excessive sleepiness.

In people 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.



References: 1. Sanders MH, Givelber RJ. Overview of obstructive sleep apnea in adults. In: Lee-Chiong T, ed. Sleep: A Comprehensive Handbook. Hoboken, NJ: John Wiley & Sons, Inc.; 2006:231-240. 2. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30(6):711-719.

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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.