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About obstructive sleep apnea (OSA)

OSA is a serious sleep disorder that can lead to death if not treated

OSA is caused by a blockage in your airway that can disrupt your breathing while you sleep. This disruption in breathing can take place up to hundreds of times over the course of a night. You may not be aware this is happening, but it can have serious consequences.1,2

18 million Americans suffer from OSA2,3

The two most common symptoms of OSA are excessive sleepiness (ES) during the day and loud snoring at night. 

Do you have OSA?

Despite being so common, many people may not know they have OSA. Up to 82% of men and 93% of women with moderate to severe OSA have not been diagnosed and, therefore, are not receiving treatment.4

People with certain conditions are at higher risk for OSA. Talk to your doctor about OSA if you have5

  • Obesity (BMI >35)
  • Heart disease
  • High blood pressure
  • Abnormal heart rhythm (including at night or while sleeping)
  • Stroke
  • Type 2 diabetes
  • High-risk driving populations
  • Preoperative for bariatric surgery

You should talk to your doctor about OSA if you are preparing for surgery. American Society of Anesthesiologists guidelines recommend preoperative screening for OSA in all patients preparing for surgery involving anesthesia.6

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

While NUVIGIL® (armodafinil) Tablets (C-IV) is used to improve wakefulness in patients with ES due to treated OSA, it is not used to treat OSA itself or its other symptoms or consequences.7

Why is it important to see a doctor about OSA?

People with OSA are at increased risk for8-12

  • High blood pressure
  • Heart disease
  • Stroke
  • Diabetes
  • Depression
  • Death 

For these reasons, it is important to talk to your doctor about treatment for your blocked airway.

Do you know the symptoms of OSA?

If you experience any of the following symptoms, you should talk to your doctor because you may be suffering from OSA:

  • Loud snoring2,5
  • Feeling tired, fatigued, or sleepy during the day (also known as excessive sleepiness or ES)5
  • Frequent sleep disruptions caused by pauses in breathing or trips to the bathroom 2,5
  • Trouble concentrating5
  • Mood/behavior change5,9
  • Gasping or choking at night5
  • Sleeping more than normal or difficulty staying asleep5
  • Morning headaches5
  • Lowered sex drive5
  • Memory loss5

While NUVIGIL is used to improve wakefulness in patients with ES due to treated OSA, it is not used to treat OSA itself or its other symptoms or consequences.7

There are several ways your doctor may treat the blockage that disrupts your breathing when you sleep.

Continuous positive airway pressure (CPAP)

CPAP is the most common treatment for OSA. It uses air pressure to help keep your airway open, so you can breathe better while you sleep.13,14

Dental devices

Your doctor or dentist may provide you with a device to hold your jaw in a forward position while you sleep. This sometimes helps you keep your airway open.13,14

Surgery

In some cases, surgery may be recommended to correct the blockage.14

Additional recommendations 

Your doctor may also suggest behavior modifications 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.15

Are you still feeling sleepy, even with treatment for OSA?

Even with treatment for OSA, many patients can still experience ES. In one clinical study, up to half of patients who used continuous positive airway pressure (CPAP) still experienced ES.16

Researchers used an objective measure of a patient’s degree of excessive sleepiness, the Multiple Sleep Latency Test (MSLT), to study people who used CPAP for at least 6 hours per night.16

Don’t make the mistake of thinking it’s normal to live this way. If you experience excessive sleepiness despite treatment for OSA, tell your doctor how hard it is for you to stay awake and discuss how to improve your wakefulness.16

* Limitations apply.

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Important Safety Information

What is NUVIGIL?

NUVIGIL® (armodafinil) Tablets [C-IV] is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work disorder (SWD), 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 OSA treatment, and it is important that you continue to use this treatment as prescribed by your doctor.

NUVIGIL may help the sleepiness caused by these conditions, but it may not stop all of your sleepiness and does not take the place of sleep.

NUVIGIL is a federally controlled substance (C-IV), so use NUVIGIL only as directed and keep in a safe place to prevent misuse and abuse. It is against the law to sell or give NUVIGIL to another person.

What important information should I know about NUVIGIL?

  • NUVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells, and may result in hospitalization and be life-threatening. If you develop a skin rash, hives, sores in your mouth, blisters, swelling, peeling, or yellowing of the skin or eyes, trouble swallowing or breathing, dark urine, or fever, stop taking NUVIGIL and call your doctor right away or get emergency help.
  • NUVIGIL is not approved for children for any condition. It is not known if NUVIGIL is safe or if it works in children under the age of 17.
  • You should not take NUVIGIL if you have had a rash or allergic reaction to NUVIGIL or PROVIGIL® (modafinil) Tablets [C-IV], or are allergic to any of the following ingredients: modafinil, armodafinil, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, or pregelatinized starch.

What are possible side effects of NUVIGIL?

  • Stop taking NUVIGIL and call your doctor or get emergency help if you get any of the following serious side effects:
    • Mental (psychiatric) symptoms, including: depression, feeling anxious, sensing things that are not really there, extreme increase in activity (mania), thoughts of suicide, aggression, or other mental problems
    • Symptoms of a heart problem, including: chest pain, abnormal heart beat, and trouble breathing
  • Common side effects of NUVIGIL are headache, nausea, dizziness, and trouble sleeping. These are not all the side effects of NUVIGIL.
  • Tell your doctor if you get any side effect that bothers you or that does not go away. Talk to your doctor for medical advice about side effects.

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.
  • Tell your doctor about all of the medicines you take. Women who use hormonal birth control may have a higher chance of getting pregnant while taking and for one month after stopping NUVIGIL. Talk to your doctor about other birth control methods while taking NUVIGIL.

You are encouraged to report 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 for medical advice about your condition or treatment.

Please read the Medication Guide for Patients in the Full Prescribing Information for NUVIGIL.

References:

  1. Carney PR, Berry RB, Geyer JD. Clinical Sleep Disorders. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:255.

  2. 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.

  3. National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health website. http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm. Accessed April 26, 2010.

  4. Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997;20(9):705-706.

  5. Epstein LJ, Kristo D, Strollo PJ Jr., et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;5(3):263-276.

  6. Gross JB, Bachenberg KL, Benumof JL, et al. Practice Guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006;104(5):1081-1093.

  7. NUVIGIL [prescribing information]. Frazer, PA: Cephalon, Inc; 2010.

  8. Naughton MT. The link between obstructive sleep apnea and heart failure: underappreciated opportunity for treatment. Curr Heart Fail Rep. 2006;3(4):183-188.

  9. Aldrich MS. Sleep Medicine. New York, NY: Oxford University Press, Inc.;1999.

  10. Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004;291(16):2013-2016.

  11. Peppard PE, Szklo-Coxe M, Hla KM, Young T. Longitudinal association of sleep-related breathing disorder and depression. Arch Intern Med. 2006;166(16):1709-1715.

  12. Marshall NS, Wong KKH, Liu PY, Cullen SRJ, Knuiman MW, Grunstein RR. Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study. Sleep. 2008;31(8):1079-1085.

  13. Kushida CA, Littner MR, Hirshkowitz M, et al. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep. 2006;29(3):375-380.

  14. Veasey SC, Guilleminault C, Strohl KP, Sanders MH, Ballard RD, Magalang UJ. Medical therapy for obstructive sleep apnea: a review by the Medical Therapy for Obstructive Sleep Apnea Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep. 2006;29(8):1036-1044.

  15. 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.

  16. 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.