IMPORTANT SAFETY INFORMATION
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IMPORTANT SAFETY INFORMATION
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. Read more Important Safety Information

What is ES?

Excessive sleepiness (ES) is defined as having trouble staying awake enough to do the things you usually do. ES is a symptom of shift work disorder (SWD), obstructive sleep apnea (OSA), and narcolepsy.

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What is SWD?

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What is SWD?

SWD is a medical condition that can occur if you work nights, early mornings, or rotating shifts that require you to be awake during the night and asleep during the day.

SWD is a medical condition that can be diagnosed and treated by a doctor. It can occur if you work nights, early mornings, or rotating shifts that require you to be awake during the night and asleep during the day.

SWD occurs when your work schedule is out of sync with your body's internal sleep-wake clock—your body is telling you to go to sleep when your work schedule needs you to stay awake, and you can feel very sleepy during your shift.


Are you working shifts?

If you work night, early morning, or rotating shifts, your work schedule may be out of sync with your circadian rhythm.

MODEL OF SLEEP-WAKE CYCLE

A Wide Range of Occupations Requires Either Permanent or Occasional Shift Work


Professional and Business Services

  • accountants
  • stockbrokers
  • customer service reps
  • IT support staff
  • other people with corporate jobs

Healthcare Professionals

  • emergency room physicians
  • nurses
  • overnight pharmacists

Leisure, Entertainment, and Hospitality

  • bartenders
  • servers
  • chefs
  • casino dealers
  • performers
  • radio DJs
  • concierges
  • doormen

Production and Manufacturing

  • steel workers
  • textile workers
  • other factory workers

Protective Services

  • firefighters
  • dispatchers
  • security guards
  • police

Wholesale and Retail Trade

  • warehouse workers
  • department store and other retail store workers

Use the Epworth Sleepiness Scale tool and the Doctor Discussion Guide at your next visit to have a more informed discussion with your doctor.

While NUVIGIL is used to improve wakefulness in people with ES due to SWD, it is not used to treat SWD itself or its other symptoms or risk factors.

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in people with ES due to SWD, it is not used to treat SWD itself or its other symptoms or risk factors.

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What is OSA?

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What is OSA?

OSA is a sleep disorder that can cause serious health issues if not treated. OSA is caused by a blockage in your airway that can disrupt your breathing while you sleep. This disruption in breathing can take place multiple times over the course of a night, and you may not even realize it’s happening. It can disrupt your sleep and cause you to be sleepy during the day.

How common is OSA?

OSA affects more than 18 million Americans. 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.

People with certain conditions are at higher risk for OSA. Talk to your doctor about OSA if you have or have had:

  • Obesity (your BMI* is greater than 35)
  • Heart disease
  • High blood pressure
  • Abnormal heart rhythm (including at night or while sleeping)
  • Stroke
  • Type 2 diabetes

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.

Treatments for OSA

If you have OSA, your doctor may prescribe the following treatment options:

  • Continuous positive airway pressure (CPAP)
    • CPAP is the most common treatment for OSA. It uses air pressure to help keep your airway open, so you can breathe better while you sleep
  • Dental devices
    • Your doctor or dentist may provide you with a device to hold your jaw in a forward position while you sleep. This sometimes helps you keep your airway open
  • Surgery
    • In some cases, surgery may be recommended to correct the blockage

Are you still feeling sleepy, even with treatment for OSA?

While CPAP is an effective way to treat OSA, it may not resolve your ES. You should talk to your doctor if you are:

  • Still sleepy, tired, or fatigued despite using your CPAP
  • Always struggling to stay awake during the day
  • Often too tired to spend time with family and friends

Many people being treated for OSA may believe it's normal to live with ES. However, there is an option to treat residual ES.

Use the Epworth Sleepiness Scale tool and the Doctor Discussion Guide at your next visit to have a more informed discussion with your doctor.

While NUVIGIL is used to improve wakefulness in people with ES due to OSA, it is not used to treat OSA itself or its other symptoms or risk factors.

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in people with ES due to OSA, it is not used to treat OSA itself or its other symptoms or risk factors.


*BMI=body mass index.

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What is narcolepsy?

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What is narcolepsy?

Narcolepsy is a brain disorder that affects 1 in every 3000 Americans. Narcolepsy occurs when the brain cannot normally regulate cycles of sleep and wake. This can cause daytime ES that results in episodes of falling asleep suddenly.


Most people who suffer from narcolepsy suffer from ES

People with narcolepsy do not necessarily sleep more than the average person. In fact, regardless of how well they sleep, people with narcolepsy experience ES.

In addition to ES, many people with narcolepsy experience sudden loss of muscle tone (called cataplexy). This often occurs in the knees, face, and neck, and may be triggered by emotions like excitement or surprise.


What causes narcolepsy?

Narcolepsy may have several causes, but most people with narcolepsy have low levels of the chemicals in the brain that promote wakefulness.


Impact of narcolepsy

Because the daytime episodes due to narcolepsy can occur at any time during the day, narcolepsy is very disabling and has a profound effect on the social and work lives of people with the disorder.

  • Narcolepsy can threaten safety, as people may fall asleep while performing various activities
  • People with narcolepsy often fall asleep several times a day, while at work or school, or even during a conversation or meal

Treatment for narcolepsy

There is no cure for narcolepsy, but making lifestyle or behavioral changes can help manage symptoms of the disorder. For example, people may take scheduled naps during the day to avoid falling asleep unexpectedly. Medications are also available to treat ES due to narcolepsy. Be sure to talk to your doctor about your ES due to narcolepsy. Use the Epworth Sleepiness Scale tool and the Doctor Discussion Guide at your next visit to have a more informed discussion with your doctor.

While NUVIGIL is used to improve wakefulness in people with ES due to narcolepsy, it is not used to treat narcolepsy itself or its other symptoms or risk factors.

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in people with ES due to narcolepsy, it is not used to treat narcolepsy itself or its other symptoms or risk factors.

 Important Safety Information

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

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.

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.

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.

Ask your doctor to write dispense as written (DAW)

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your first fill free and refills as low as $5

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© 2016 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.
All rights reserved. NUV-40859 Apr 2016