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Is Treatment for Obstructive Sleep Apnea (OSA) Still Leaving You Sleepy?

18 Million Americans Suffer from Obstructive Sleep Apnea (OSA)1

The two most common symptoms of OSA are excessive sleepiness (ES) in the daytime and loud snoring. Continuous positive airway pressure (CPAP) is the most common treatment for OSA. CPAP allows for unobstructed breathing to take place, making it easier for a person to breathe during sleep.2 However, many patients using CPAP for OSA therapy still suffer from ES.3

Learn if you could be suffering from ES despite treatment for OSA.
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While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with ES despite treatment for OSA, they are not used to treat OSA itself or any other conditions that are associated with OSA.

Next: What Is Obstructive Sleep Apnea (OSA)?

What Is Obstructive Sleep Apnea (OSA)?

OSA is caused when your airway becomes blocked during sleep. This disruption in breathing can take place up to hundreds of times over the course of a night.4,5 You may not be aware this is happening, but it can have serious consequences, increasing your risk for a number of serious health conditions.6-9

Find Out if You’re Suffering from OSA
Continue

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with excessive sleepiness (ES) despite treatment for OSA, they are not used to treat OSA itself or any other conditions that are associated with OSA.

Next: Do You Have Obstructive Sleep Apnea (OSA)?

Do You Have Obstructive Sleep Apnea (OSA)?

Despite being so common, many people may not know they have OSA. People with certain conditions are at a higher risk for the condition:11

  • Obesity (body mass index [BMI] >35)
  • Heart disease
  • High blood pressure
  • Abnormal heart rhythm, including at night or while sleeping
  • Stroke
  • Type 2 diabetes
  • Preoperative for any condition requiring surgery12

If you have any of these conditions, you should ask your doctor about OSA.

Learn More about the Symptoms of OSA
Continue

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with excessive sleepiness (ES) despite treatment for OSA, they are not used to treat OSA itself or any other conditions that are associated with OSA.

Next: What Are the Symptoms of Obstructive Sleep Apnea (OSA)

What Are the Symptoms of Obstructive Sleep Apnea (OSA)?

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

  • Loud snoring4,11
  • Feeling tired, fatigued, or sleepy during the day (also known as excessive sleepiness or ES)11
  • Frequent sleep disruptions caused by pauses in breathing4
  • Frequent trips to the bathroom at night11
  • Trouble concentrating11
  • Mood/behavior change6,11
  • Gasping or choking at night11
  • Sleeping more than normal or difficulty staying asleep11
  • Morning headaches11
  • Lowered sex drive11
  • Memory loss11
Understand Why It’s Important to Talk to Your Doctor about OSA
Continue

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with excessive sleepiness (ES) despite treatment for OSA, they are not used to treat OSA itself or any other conditions that are associated with OSA.

Next: Why Is It Important to See a Doctor about OSA?

Why Is It Important to See a Doctor about OSA?

People with obstructive sleep apnea (OSA) are at increased risk for a number of serious health conditions, including high blood pressure, heart disease, stroke, diabetes, depression, and death.6-9, 13

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

Do You Still Feel Tired Despite OSA Treatment?
Continue

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with excessive sleepiness (ES) despite treatment for OSA, they are not used to treat OSA itself or any other conditions that are associated with OSA.

Next: Do You Still Feel Tired Even with OSA Treatment?

Do You Still Feel Tired Even with OSA Treatment?

Continuous Positive Airway Pressure (CPAP)2

CPAP is the most common treatment for obstructive sleep apnea (OSA). CPAP is delivered through a machine that provides a stream of compressed air through a hose to a nasal pillow, nose mask, or full-face mask. This delivery allows for unobstructed breathing to take place, making it easier for a person to breathe during sleep.

While CPAP is an effective way to treat OSA, it may not resolve your excessive sleepiness (ES).

You Should Talk to Your Doctor if You Are…

  • Still sleepy, tired, or fatigued despite using your CPAP14
  • Always struggling to stay awake during the day15, 16
Learn How NUVIGIL® (armodafinil) Tablets [C-IV] Can Help Improve Your Wakefulness17
Continue

While NUVIGIL is used to improve wakefulness in patients with ES despite treatment for OSA, it is not used to treat OSA itself or any other conditions that are associated with OSA.

Next: NUVIGIL Improves Wakefulness in Patients with Excessive Sleepiness despite treatment for OSA17

NUVIGIL Improves Wakefulness in Patients with Excessive Sleepiness Despite Treatment for OSA17

NUVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) despite treatment for OSA obstructive sleep apnea (OSA).

  • NUVIGIL was studied in two 12-week clinical trials that included 658 patients with treated OSA
  • Patients who took NUVIGIL experienced significant improvement in wakefulness throughout the day17
More than 800,000 prescriptions for NUVIGIL® have been written since 200917
  • In clinical studies, most reported side effects were mild to moderate17
  • Common side effects of NUVIGIL were headache, nausea, dizziness, and trouble sleeping17
  • 7% of patients taking NUVIGIL stopped treatment due to side effects, compared with 4% of patients taking a sugar pill (placebo)17

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.

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.

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Find Out How NUVIGIL Can Improve Wakefulness in Patients Treated for OSA17
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Using CPAP Therapy but Still Sleepy?
NUVIGIL May Help.17

For patients who are being treated for obstructive sleep apnea (OSA), including those who are using continuous positive airway pressure (CPAP) therapy, but are still sleepy, NUVIGIL improves wakefulness throughout the day.17

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 your condition, but it may not stop all of your sleepiness and does not take the place of sleep. Only you and your doctor can decide if NUVIGIL is right for you, so make an appointment to see your doctor today.

Try NUVIGIL FREE, Then Continue with Savings
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Download Your FREE Voucher and Savings Card Now

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 Medication Guide in the full prescribing information for NUVIGIL.

References

  1. 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.
  2. Institute for Clinical Systems Improvement. Health Care Guideline: Diagnosis and Treatment of Obstructive Sleep Apnea. 6th ed. Bloomington, MN: Institute for Clinical Systems Improvement; 2008.
  3. 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.
  4. 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.
  5. Carney PR, Berry RB, Geyer JD. Clinical Sleep Disorders. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:255.
  6. Aldrich MS. Sleep Medicine. New York, NY: Oxford University Press, Inc.; 1999.
  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. Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004;291(16):2013-2016.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. Chung F, Yegneswaran B, Liao P, et al. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008;108(5):812-821.
  15. Reishtein JL, Pack AI, Maislin G, et al. Sleepiness and relationships in obstructive sleep apnea. Issues Ment Health Nurs. 2006;27(3):319-330.
  16. Mulgrew AT, Ryan CF, Fleetham JA, et al. The impact of obstructive sleep apnea and daytime sleepiness on work limitation. Sleep Med. 2007;9(1):42-53.
  17. NUVIGIL [prescribing information]. Frazer, PA: Cephalon, Inc; 2010.
  18. IMS HEALTH National Prescription Audit Plus ™ (June 2009-September 2010).

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