What is NUVIGIL?

NUVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders:

• Obstructive sleep apnea (OSA)
  • In patients with OSA, NUVIGIL is used along with other medical treatments for this sleep disorder. NUVIGIL is not a replacement for your current treatment. Consult your doctor about the importance of continuing your current OSA treatment while taking NUVIGIL
• Shift work disorder (SWD)
• Narcolepsy

You should be diagnosed with one of these sleep disorders before taking NUVIGIL. Sleepiness can be a symptom of other medical conditions that need to be treated.

NUVIGIL will not treat the sleep disorders mentioned above. NUVIGIL may help with the sleepiness caused by these conditions, but it may not stop all of your sleepiness.

NUVIGIL does not take the place of getting enough sleep.

Follow your doctor’s advice about good sleep habits and using other treatments.

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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.

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Who should not take NUVIGIL?

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.

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Can I become addicted to NUVIGIL?

NUVIGIL is a federally controlled substance [C-IV] because it has the potential to 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. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Some effects of NUVIGIL on the brain are the same as other medicines called stimulants. These effects may lead to abuse of or dependence on NUVIGIL. Before starting NUVIGIL, tell your doctor if you have ever abused drugs, including other stimulant medicines.

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What is a federally controlled substance [C-IV]?¹

The schedules of controlled drugs are determined by the Drug Enforcement Agency (DEA) and are based on a drug’s potential for abuse.

• NUVIGIL is a Schedule IV [C-IV] medication because it has the potential to be abused or lead to dependence
• Schedule IV medications have less potential for abuse and dependence than Schedule II medications, like amphetamines and methylphenidate and Schedule III medications like anabolic steroids

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What should I tell my doctor before starting NUVIGIL?

• Tell your doctor about all of your health conditions, including if you have a 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
• Women who use hormonal birth control may have a higher chance of getting pregnant while taking NUVIGIL, and for one month after stopping NUVIGIL
• Talk to your doctor about other birth control methods while taking NUVIGIL

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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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How do I get a trial offer for NUVIGIL, and can I save on future prescriptions?

You can get your first prescription of NUVIGIL FREE, and you may also be eligible for a co-pay as low as $5 on your future prescriptions.* Print a copy of the FREE offer today, present it to your doctor, and find out if NUVIGIL is right for you. It's that easy.
Only your doctor can decide if NUVIGIL is right for you. Get your FREE offer.

*Limitations apply.

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How should I take NUVIGIL?

Take NUVIGIL exactly as prescribed by your doctor. Do not change your dose of NUVIGIL without talking to your doctor. Do not take more NUVIGIL than prescribed.

• Your doctor will tell you the right time of day to take NUVIGIL
• Patients with excessive sleepiness (ES) due to treated obstructive sleep apnea (OSA) or narcolepsy usually take 1 dose of NUVIGIL every morning
• Patients with ES due to shift work disorder (SWD), usually take NUVIGIL about 1 hour before their work shift. 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 fall asleep
• You can take NUVIGIL with or without food
• If you take more than your prescribed dose or if you overdose, call your doctor or poison-control center right away

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What should I avoid while taking NUVIGIL?

• Do not drive or do other dangerous activities until you and your doctor know how NUVIGIL affects you
• Avoid drinking alcohol

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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.
• 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
  • other mental problems
• symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing

Common side effects that can happen in anyone who takes NUVIGIL include:

• headache
• nausea
• dizziness
• 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.

Some effects of NUVIGIL on the brain are the same as other medicines called "stimulants". These effects may lead to abuse or dependence on NUVIGIL.Call your doctor for medical advice about side effects.

You may report side effects to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or by fax at 1-800-FDA-0178.

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Will my sleep be affected when I take NUVIGIL?

If you take NUVIGIL as directed, your ability to sleep when you want to will not typically be affected, although 5% of patients taking NUVIGIL in clinical studies experienced trouble sleeping, versus 1% of patients who received a sugar pill.²

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If I have obstructive sleep apnea (OSA) and am taking NUVIGIL, do I still need to use my breathing device when I sleep?

If you have OSA, it is important to talk to your doctor about your current treatment, as NUVIGIL will not treat the obstruction that causes your blocked airway.

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Do I have to go back to my doctor every time I need a refill of NUVIGIL?

You should ask your doctor about refills when you receive a NUVIGIL prescription.

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Where can I get the most up-to-date information about NUVIGIL?

Read the Medication Guide that comes with NUVIGIL before you start taking it and each time you get a refill. There may be new information. The Medication Guide does not take the place of talking with your doctor about your condition or treatment.

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How can I get additional information about NUVIGIL?

These questions summarize important information about NUVIGIL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about NUVIGIL, including the Full Prescribing Information. For more information, please call 1-800-896-5855.

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