Obstructive sleep apnea (OSA) is a serious sleep disorder that can lead to death if not treated

Obstructive sleep apnea (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 2 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
  • Preoperative for bariatric surgery

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

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

IMPORTANT SAFETY INFORMATION FOR NUVIGIL

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:
    • A serious rash or serious allergic reaction (see above)
    • 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.

There is a registry for women who become pregnant during treatment with NUVIGIL. The purpose of this registry is to collect information about the safety of NUVIGIL during pregnancy. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106 or by visiting www.NUVIGILpregnancyregistry.com.

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. Available at http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm. Accessed January 13, 2012.
  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; 2013.