provigil

Description

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Provigil promotes wakefulness and is used to treat excessive daytime sleepiness caused by narcolepsy, obstructive sleep apnea (OSA), or shift work sleep (SWS) disorder.

• Provigi does not treat the underlying disorder, it only makes people feel more awake.
• Provigi does not take the place of other treatments for narcolepsy or OSA. These should be continued while you are taking Provigi.

Provigil’s exact mechanism of action is unclear. However, it’s believed to work by affecting brain chemicals that regulate sleep and wakefulness. While similar to stimulants like amphetamine and methylphenidate, Provigil has a different chemical structure. Provigi belongs to the drug class called CNS stimulants.

Provigi is classified as a Schedule IV (4) controlled substance due to its potential for misuse and dependence. Misuse of Provigi is illegal and harmful and you should always keep it in a safe place and never share it with others. Tell your doctor if you have a history of substance abuse.

Provigi gained FDA approval on December 24, 1998. A Provigil generic is available under the name modafinil.

Nuvigil is a purified version of Provigil (see Nuvigil (armodafinil) vs Provigil (modafinil): How do they compare?).

Provigi side effects

The most common side effects of Provigi are:

• a headache
• dizziness
• feeling nervous or anxious
• back pain
• nausea
• diarrhea
• an upset stomach
• sleep problems (insomnia)
• poor appetite
• a stuffy nose.

Weight loss is not a recognized side effect of Provigi, although nausea and poor appetite are common side effects of Provigi that may lead to weight loss.

Serious side effects and warnings

You should not use Provigi if you have ever had an allergic reaction or developed a skin rash while taking modafinil, Provigi, armodafinil, or Nuvigil. Angioedema and hypersensitivity reactions (including rash, difficulty swallowing, narrowing of the airways, and hypersensitivity reactions that affect multiple organs) have been reported with medications in the same class as Provigi. Stop taking Provigi and get emergency medical help if you have signs of an allergic reaction to Provigi such as hives (an itchy skin rash), difficulty breathing, or swelling of your face, lips, tongue, or throat.

Provigi can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you develop any of the following, no matter how minor it appears:

• skin rash or hives, blisters or peeling
• mouth sores, trouble swallowing
• fever, shortness of breath
• swelling in your legs
• dark urine, jaundice (yellowing of the skin or eyes)
• swelling in your face, eyes, lips, tongue, or throat.

Provigi may impair your thinking or reaction time. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activities until you know how this medication will affect your level of wakefulness. Provigi may not return your level of alertness to what it was before you developed narcolepsy or OSA.

Psychiatric side effects, such as anxiety, confusion, insomnia, depression, or agitation, have been reported in people treated with Provigil. Stop using Provigi and call your doctor at once if you have:

• depression or suicidal thoughts or actions
• anxiety
• hallucinations or unusual thoughts or behavior
• aggression
• being more active or talkative than usual.

Cardiovascular side effects, including chest pain, trouble breathing, uneven heartbeats, shortness of breath, or changes on an ECG have been reported in trials with Provigil. Stop taking Provigil and call your doctor if you have chest pain, trouble breathing, or uneven heartbeats.

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 the FDA at 1-800-FDA-1088.

Before taking

Do not take Provigil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).

To make sure Provigil is safe for you, tell your doctor about all your medical conditions, including if you have:

• angina (chest pain)
• cirrhosis or other liver problem
• kidney disease
• high blood pressure, heart disease, or history of heart attack
• a history of mental illness or psychosis
• history of alcoholism or drug addiction.
• are pregnant or intending to become pregnant
• are breastfeeding or intending to breastfeed.

Provigil is not approved for use by anyone younger than 17 years old.

Pregnancy

Based on animal data, Provigil may harm an unborn baby. There have been no adequate studies in humans. Talk to your healthcare provider about using adequate birth control methods while taking Provigil, if you are a woman of childbearing potential. Be aware that Provigil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment and for one month after finishing your treatment. Talk with your doctor about the best methods of birth control to use while taking Provigil.

A pregnancy registry has been established to collect information on the pregnancy outcomes of women exposed to Provigil if they inadvertently become pregnant while taking Provigil. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll in the registry by calling 1-866-404-4106 (toll-free).

Breastfeeding

It is not known whether modafinil passes into breast milk or if it could harm a nursing baby.