Provigil

DRUG DESCRIPTION

PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl) sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

The chemical structure is:

PROVIGIL®
 (modafinil) Structural Formula Illustration

Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.

What are the possible side effects of modafinil (Provigil)?

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 modafinil 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 Provigil »

What are the precautions when taking modafinil (Provigil)?

Before taking modafinil, tell your doctor or pharmacist if you are allergic to it; 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: a certain heart problem (left ventricle thickening), a history of previous reaction (e.g., chest pain, irregular heartbeat) to stimulants.

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, heart valve problem), liver problems, kidney problems,...

Read All Potential Precautions of Provigil »


Provigil Consumer (continued)

SIDE EFFECTS: Headache, nausea, nervousness, anxiety, dizziness, and difficulty sleeping may occur. If any of these effects persist or worsen, notify 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: mental/mood changes (e.g., agitation, confusion, depression, abnormal thoughts, hallucinations).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fast/pounding/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat).

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

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 modafinil, tell your doctor or pharmacist if you are allergic to it; 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: a certain heart problem (left ventricle thickening), a history of previous reaction (e.g., chest pain, irregular heartbeat) to stimulants.

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, heart valve problem), liver problems, kidney problems, mental/mood problems (e.g., mania, psychosis), personal or family history of regular use/abuse of drugs/alcohol.

Sleep disorders may decrease your ability to react quickly. Though modafinil helps keep you awake, you still may not be able to perform tasks requiring alertness safely (e.g., driving). This drug may 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.

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.


Provigil Patient Information Including Side Effects

Brand Names: Provigil

Generic Name: modafinil (Pronunciation: moe DAF i nil)

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

What is modafinil (Provigil)?

Modafinil is a medication that promotes wakefulness.

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

Modafinil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of modafinil (Provigil)?

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

What is the most important information I should know about modafinil (Provigil)?

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

Before using modafinil, 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.

Modafinil 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 modafinil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to modafinil 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 modafinil. 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.

Related Drug Centers
  • Provigil


Related Drugs Index: