What is obstructive sleep apnea (OSA)?

Obstructive sleep apnea is a medical condition that needs diagnosis and treatment by a doctor.

OSA is caused by a blockage in your airway that can disrupt your breathing while you sleep. This disruption in breathing can cause you to wake up repeatedly throughout the night.1-3 You may not be aware that this is happening, but it can prevent you from a good night's sleep.

The anatomy of a blocked airway

The anatomy of a blocked airway.

An estimated 18 million Americans suffer from obstructive sleep apnea.4

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, don't get treated.5

People with certain conditions are at a higher risk for OSA. You should talk to your doctor about OSA if you have6:

  • Type 2 diabetes
  • Obesity
  • Stroke
  • Congestive heart failure
  • High blood pressure that continues even with treatment
  • Other heart problems

You should also talk to your doctor about OSA if you are preparing for bariatric surgery.

Why is it important to see a doctor about OSA?

People with OSA are at increased risk for:

  • High blood pressure7
  • Heart disease7
  • Stroke8
  • Diabetes9
  • Depression10
  • Death11

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 snoring1,6
  • Feeling tired, fatigued, or sleepy during the day (also known as excessive sleepiness or ES)6
  • Frequent sleep disruptions caused by pauses in breathing or trips to the bathroom1,6
  • Trouble concentrating6
  • Mood/behavior change6,8
  • Gasping or choking at night6
  • Sleeping more than normal or difficulty staying asleep6
  • Morning headaches6
  • Lowered sex drive6
  • Memory loss6

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with treated OSA, they are not used to treat OSA itself or its other symptoms or consequences.

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. Carney PR, Berry RB, Geyer JD. Clinical Sleep Disorders. Philadelphia, PA: Lippincott Williams & Wilkens; 2005:255. 3. Attarian HP, Sabri AN. When to suspect obstructive sleep apnea syndrome. Symptoms may be subtle, but treatment is straightforward. Postgrad Med. 2002;111(3):70-76; quiz 14. 4. National Institute of Neurological Disorders and Stroke. Brain Basics: Understanding Sleep. National Institute of Neurological Disorders and Stroke, National Institutes of Health Web site. http://www.ninds.nih.gov/disorders/brain_basics/understanding_sleep.htm. Accessed May 11, 2009. 5. 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;20:705-706. 6. Epstein LJ, Kristo D, Strollo PJ, 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. 7. Naughton MT. The link between obstructive sleep apnea and heart failure: underappreciated opportunity for treatment. Curr Heart Fail Rep. 2006;3(4):183-188. 8. Aldrich MS. Sleep Medicine. New York, NY: Oxford University Press, Inc.; 1999. 9. Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004;291(16):2013-2016. 10. 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. 11. 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.

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.