Generic Name: armodafinil (ar-moe-DAF-i-nil)
Brand Name: Nuvigil

Nuvigil is used for:

Improving wakefulness in patients with excessive sleepiness from sleep apnea, narcolepsy, or shift work disorder. It may also be used for other conditions as determined by your doctor.

Nuvigil is a wakefulness-promoting agent. Exactly how it works is not known. Nuvigil affects certain chemicals in the brain that may affect sleep.

Do NOT use Nuvigil if:

  • you are allergic to any ingredient in Nuvigil or to modafinil
  • you have a history of developing a rash after taking Nuvigil or modafinil
  • you have a history of certain heart or heart valve problems (eg, mitral valve prolapse, left ventricular hypertrophy)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Nuvigil:

Some medical conditions may interact with Nuvigil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you or a family member has a history of mental or mood problems (eg, depression, mania, psychosis), suicidal thoughts or actions, or alcohol or substance abuse
  • if you have chest pain (angina), heart problems, or high blood pressure, or if you have had a heart attack
  • if you have liver or kidney problems
  • if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine)

Some MEDICINES MAY INTERACT with Nuvigil. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Erythromycin or ketoconazole because they may increase the risk of Nuvigil's side effects
  • Carbamazepine, phenobarbital, or rifampin because they may decrease Nuvigil's effectiveness
  • Anticoagulants (eg, warfarin), benzodiazepines (eg, diazepam), clomipramine, hydantoins (eg, phenytoin), omeprazole, or propranolol because the risk of their side effects may be increased by Nuvigil
  • Cyclosporine, hormonal contraceptives (eg, birth control pills), midazolam, or triazolam because their effectiveness may be decreased by Nuvigil

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nuvigil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nuvigil:

Use Nuvigil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Nuvigil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Nuvigil refilled.
  • Take Nuvigil by mouth with or without food.
  • Your doctor will tell you what time of day to take Nuvigil. Do not change the time of day you take it without talking to your doctor.
  • If you miss a dose of Nuvigil, take it as soon as possible. If you do not remember until late afternoon or evening, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nuvigil.

Important safety information:

  • Nuvigil may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nuvigil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Nuvigil; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or change your dose without checking with your doctor.
  • Nuvigil cannot cure sleep disorders and it may not stop all of your sleepiness. Do not change your daily habits without first talking to your doctor. Discuss your level of sleepiness with your doctor at each visit. Do not use Nuvigil in place of getting enough sleep. Follow your doctor's instructions for good sleep habits and using other treatments.
  • Serious and sometimes fatal skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely reported with Nuvigil. Contact your doctor right away if you develop a rash; red, swollen, blistered, or peeling skin; or blisters on the inside of the eyes, nose, or mouth.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Nuvigil. To prevent pregnancy, use an extra form of birth control (eg, condoms) while you are taking Nuvigil and for 1 month after stopping Nuvigil.
  • Lab tests, including blood pressure, heart, and liver function, may be performed while you use Nuvigil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Nuvigil with caution in the ELDERLY; they may be more sensitive to its effects.
  • Nuvigil should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nuvigil while you are pregnant. It is not known if Nuvigil is found in breast milk. If you are or will be breast-feeding while you use Nuvigil, check with your doctor. Discuss any possible risks to your baby.

Some people who use Nuvigil for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Nuvigil suddenly, you may have WITHDRAWAL symptoms. These may include sleepiness. Discuss any questions or concerns with your doctor or pharmacist.

Possible side effects of Nuvigil:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blisters on the inside of the eyes, nose, or mouth; chest pain; dark urine; fast or irregular heartbeat; fever, chills, or sore throat; mental, mood, or behavior changes (eg, aggression, agitation, anxiety, depression, exaggerated sense of well-being, hallucinations, irritability, nervousness); red, swollen, blistered, or peeling skin; shortness of breath; suicidal thoughts or actions; swelling of the legs; unusual bruising or bleeding; vomiting; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Nuvigil:

Store Nuvigil at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nuvigil out of the reach of children and away from pets.

General information:

  • If you have any questions about Nuvigil, please talk with your doctor, pharmacist, or other health care provider.
  • Nuvigil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Nuvigil or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nuvigil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nuvigil. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Nuvigil.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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