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

NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

  • narcolepsy
  • obstructive sleep apnea (OSA). NUVIGIL is used with other medical treatments for this disorder. NUVIGIL does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition. It is important that you continue to use these treatments as prescribed by your doctor.
  • shift work disorder (SWD)

NUVIGIL will not cure these sleep disorders. NUVIGIL may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. NUVIGIL does not take the place of getting enough sleep.

NUVIGIL is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep NUVIGIL in a safe place to prevent misuse and abuse. Selling or giving away NUVIGIL may harm others, and is against the law.

IMPORTANT SAFETY INFORMATION FOR NUVIGIL

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. Any of these may need to be treated in a hospital and may be life-threatening.

Stop taking NUVIGIL and call your doctor right away or get emergency help if you have any of these symptoms: skin rash, hives, sores in your mouth, or your skin blisters and peels; swelling of your face, eyes, lips, tongue, or throat; trouble swallowing or breathing; or fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine.

If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.

NUVIGIL is not approved for use in children for any medical condition. It is not known if NUVIGIL is safe or if it works in children under the age of 17 years.

Who should not take NUVIGIL?

Do not take NUVIGIL if you are allergic to any of its ingredients or have had a rash or allergic reaction to either armodafinil (NUVIGIL) or modafinil (PROVIGIL®). These medicines are very similar.

What should I tell my doctor before taking NUVIGIL?

Tell your doctor about all of your medical conditions including, if you have a history of mental health problems, including psychosis; have heart problems or had a heart attack; have high blood pressure; have liver or kidney problems; have a history of drug or alcohol abuse or addiction; are pregnant or planning to become pregnant; or are breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Hormonal birth control methods may not work while you take NUVIGIL. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking NUVIGIL, and for one month after stopping NUVIGIL.

What should I avoid while taking NUVIGIL?

  • Do not drive a car or do other dangerous activities until you know how NUVIGIL affects you.
  • You should avoid drinking alcohol.

What are possible side effects of NUVIGIL?

NUVIGIL may cause serious side effects. Stop taking NUVIGIL and call your doctor right away or get emergency help if you get any of the following:

  • a serious rash or serious allergic reaction (see above)
  • mental (psychiatric) symptoms, including: depression; feeling anxious; hearing, seeing, feeling, or sensing things that are not really there (hallucinations); an extreme increase in activity and talking (mania); thoughts of suicide; aggressive behavior, and other mental problems
  • symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing.

Common side effects of NUVIGIL include headache, nausea, dizziness, and trouble sleeping.

Tell your doctor if you get any side effect that bothers you or that does not go away while taking NUVIGIL.

These are not all the side effects of NUVIGIL. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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]. North Wales, PA: Teva Pharmaceuticals USA, Inc; 2015.