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

About NUVIGIL

More than 5.6 million prescriptions for NUVIGIL have been written since 2009.

About NUVIGIL About NUVIGIL
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NUVIGIL is taken once a day

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NUVIGIL is taken once a day

In people with SWD, OSA, or narcolepsy, NUVIGIL improves wakefulness with just one pill, once a day.

How should I take NUVIGIL?

  • Take NUVIGIL exactly as prescribed by your doctor. Your doctor will prescribe the dose of NUVIGIL that is right for you. Do not change your dose of NUVIGIL without talking to your doctor
  • Your doctor will tell you the right time of day to take NUVIGIL
    • People with excessive sleepiness (ES) due to SWD usually take NUVIGIL about 1 hour before their work shift
    • People with ES due to OSA or narcolepsy usually take 1 dose of NUVIGIL every morning
  • Do not change the time of day you take NUVIGIL unless you have talked to your doctor. If you take NUVIGIL too close to your bedtime, you may find it harder to go to sleep
  • You can take NUVIGIL with or without food
  • If you take more than your prescribed dose or if you take an overdose of NUVIGIL, call your doctor or a poison-control center right away

NUVIGIL is available in 4 strengths

What should I avoid while taking NUVIGIL?

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

Can I take other medicines (including birth control) at the same time as NUVIGIL?

  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements
  • NUVIGIL and many other medicines can interact with each other, sometimes causing side effects. NUVIGIL may affect the way other medicines work, and other medicines may affect how NUVIGIL works
  • Especially tell your doctor if you use a hormonal birth control method. NUVIGIL can affect hormonal birth control methods, including pills, shots, implants, patches, vaginal rings, and hormone-releasing intrauterine devices
    • Women who use hormonal birth control with NUVIGIL may have a higher chance of getting pregnant while taking NUVIGIL, and for 1 month after stopping NUVIGIL. Talk to your doctor about birth control methods that are right for you while using NUVIGIL
  • Keep a list of all the medicines you take. Your doctor or pharmacist will tell you if it is safe to take NUVIGIL and other medicines together
  • Do not take other medicines with NUVIGIL unless your doctor has told you it is okay
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NUVIGIL for excessive sleepiness (ES) due to SWD

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NUVIGIL for excessive sleepiness (ES) due to SWD

If you work shifts and often feel sleepy or tired when you need to be awake, NUVIGIL could improve your wakefulness. NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to SWD.

NUVIGIL does not replace sleep and may not completely resolve your excessive sleepiness (ES). Only you and your doctor can decide if NUVIGIL is right for you, so make an appointment to see your doctor today.

NUVIGIL typically does not affect your ability to sleep when you need to sleep

  • Based on sleep studies that measure nighttime breathing and brain and muscle activity, NUVIGIL typically does NOT interfere with sleep
  • 5% of people taking NUVIGIL reported trouble sleeping vs 1% of people taking a sugar pill (placebo)

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.

Common side effects with NUVIGIL

  • In people taking NUVIGIL, most reported side effects were rated as mild to moderate
  • Common side effects of NUVIGIL were headache, nausea, dizziness, and trouble sleeping
  • 7% of people taking NUVIGIL stopped treatment due to side effects compared with 4% of patients taking a sugar pill (placebo)
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NUVIGIL for excessive sleepiness (ES) due to OSA

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NUVIGIL for excessive sleepiness (ES) due to OSA

If you are currently being treated for OSA but are still experiencing excessive sleepiness (ES), NUVIGIL may be able to help improve your wakefulness. NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy despite treatment for obstructive sleep apnea.

NUVIGIL does not replace sleep and may not completely resolve your ES. Only you and your doctor can decide if NUVIGIL is right for you, so make an appointment to see your doctor today.

  • In people 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 with sleepiness caused by this 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

NUVIGIL typically does not affect your ability to sleep when you need to sleep

  • Based on sleep studies that measure nighttime breathing and brain and muscle activity, NUVIGIL typically does NOT interfere with sleep
  • 5% of people taking NUVIGIL reported trouble sleeping vs 1% of people taking a sugar pill (placebo)

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

Common side effects with NUVIGIL

  • In people taking NUVIGIL, most reported side effects were rated as mild to moderate
  • Common side effects of NUVIGIL were headache, nausea, dizziness, and trouble sleeping
  • 7% of people taking NUVIGIL stopped treatment due to side effects compared with 4% of people taking a sugar pill (placebo)
EXPAND  

NUVIGIL for excessive sleepiness (ES) due to narcolepsy

COLLAPSE  

NUVIGIL for excessive sleepiness (ES) due to narcolepsy

If you have narcolepsy and experience excessive sleepiness (ES), NUVIGIL may be able to improve your wakefulness. NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to narcolepsy.

NUVIGIL does not replace sleep and may not completely resolve your ES. Only you and your doctor can decide if NUVIGIL is right for you, so make an appointment to see your doctor today.

NUVIGIL typically does not affect your ability to sleep when you need to sleep

  • Based on sleep studies that measure nighttime breathing and brain and muscle activity, NUVIGIL typically does NOT interfere with sleep
  • 5% of people taking NUVIGIL reported trouble sleeping vs 1% of people taking a sugar pill (placebo)

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.

Common side effects with NUVIGIL

  • In people taking NUVIGIL, most reported side effects were rated as mild to moderate
  • Common side effects of NUVIGIL were headache, nausea, dizziness, and trouble sleeping
  • 7% of people taking NUVIGIL stopped treatment due to side effects compared with 4% of people taking a sugar pill (placebo)
 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) on your NUVIGIL prescription to help get your first fill free and refills as low as $5 (limitations apply).

Ask your doctor to write dispense as written (DAW)

on your NUVIGIL prescription to help get
your first fill free and refills as low as $5

Savings Card
Savings Card

*Limitations apply.


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