Nuvigil

DRUG DESCRIPTION

NUVIGIL® (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl) sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

The chemical structure is:

NUVIGIL®
  (armodafinil) Structural Formula Illustration

Armodafinil is a white to off-white, crystalline powder that is very slightly soluble in water, sparingly soluble in acetone and soluble in methanol. NUVIGIL tablets contain 50, 150 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

What are the possible side effects of armodafanil (Nuvigil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using armodafanil and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • easy bruising or bleeding;
  • white patches or sores inside your mouth or on your...

Read All Potential Side Effects and See Pictures of Nuvigil »

What are the precautions when taking armodafinil (Nuvigil)?

Before taking armodafinil, tell your doctor or pharmacist if you are allergic to it; or to modafinil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (e.g., enlarged heart, mitral valve problem), history of problems (e.g., chest pain, irregular heartbeat) after taking stimulants such as amphetamines.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart problems (e.g., chest pain, heart attack, irregular...

Read All Potential Precautions of Nuvigil »


Nuvigil Consumer (continued)

SIDE EFFECTS: Headache, nausea, dry mouth, anxiety, dizziness, and difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., agitation, confusion, depression, hallucinations, rare thoughts of suicide), unusual tiredness, dark urine, yellowing eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe abdominal pain, chest pain, fast/pounding/irregular heartbeat.

Rarely, this medication may cause a serious (rarely fatal) rash. You may not be able to tell this serious reaction apart from a minor rash. Therefore, stop taking this drug and seek immediate medical attention if you develop any rash.

A very serious allergic reaction to this drug is rare. However, stop taking armodafinil and seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/hives, skin blisters/peeling, sores in the mouth, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing/swallowing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking armodafinil, tell your doctor or pharmacist if you are allergic to it; or to modafinil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (e.g., enlarged heart, mitral valve problem), history of problems (e.g., chest pain, irregular heartbeat) after taking stimulants such as amphetamines.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart problems (e.g., chest pain, heart attack, irregular heartbeat), liver problems, kidney problems, mental/mood disorders (e.g., depression, mania, psychosis), personal or family history of regular use/abuse of drugs/alcohol.

Sleep disorders may decrease your ability to react quickly. Though armodafinil helps keep you awake, you still may not be able to safely perform tasks that require quick reactions (e.g., driving). This drug may also make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially serious rashes.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Nuvigil Patient Information Including Side Effects

Brand Names: Nuvigil

Generic Name: armodafanil (Pronunciation: ar moe DAF i nil)

  • What is armodafanil (Nuvigil)?
  • What are the possible side effects of armodafanil (Nuvigil)?
  • What is the most important information I should know about armodafanil (Nuvigil)?
  • What should I discuss with my health care provider before taking armodafanil (Nuvigil)?
  • How should I take armodafanil (Nuvigil)?
  • What happens if I miss a dose (Nuvigil)?
  • What happens if I overdose (Nuvigil)?
  • What should I avoid while taking armodafanil (Nuvigil)?
  • What other drugs will affect armodafanil (Nuvigil)?
  • Where can I get more information?

What is armodafanil (Nuvigil)?

Armodafanil is a medication that promotes wakefulness.

Armodafanil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafanil may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of armodafanil (Nuvigil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using armodafanil and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • easy bruising or bleeding;
  • white patches or sores inside your mouth or on your lips;
  • hallucinations, unusual thoughts or behavior;
  • depression, anxiety; or
  • chest pain, uneven heart beats.

Less serious side effects may include:

  • headache, dizziness;
  • feeling nervous or agitated;
  • nausea, diarrhea;
  • trouble sleeping (insomnia); or
  • dry mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What is the most important information I should know about armodafanil (Nuvigil)?

You should not use this medication if you are allergic to armodafanil or modafanil (Provigil).

Before using armodafanil, tell your doctor if you have angina (chest pain), liver or kidney disease, a heart problem, a history of drug addiction, if you take blood pressure medication, or if you have recently had a heart attack.

Armodafanil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Stop taking armodafanil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to armodafanil has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash.

There may be other drugs that can interact with armodafanil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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