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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.