Pronunciation: pro-vig-ill
Generic name: modafinil
Dosage form: oral tablet
Drug class: CNS stimulants

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 18, 2024.

What is Provigil?

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

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

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. Provigil belongs to the drug class called CNS stimulants.

Provigil is classified as a Schedule IV (4) controlled substance due to its potential for misuse and dependence. Misuse of Provigil 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.

Provigil 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?).

Provigil side effects

The most common side effects of Provigil 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 Provigil, although nausea and poor appetite are common side effects of Provigil that may lead to weight loss.

Serious side effects and warnings

You should not use Provigil if you have ever had an allergic reaction or developed a skin rash while taking modafinil, Provigil, 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 Provigil. Stop taking Provigil and get emergency medical help if you have signs of an allergic reaction to Provigil such as hives (an itchy skin rash), difficulty breathing, or swelling of your face, lips, tongue, or throat.

Provigil 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.

Provigil 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. Provigil 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 Provigil 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. 

How should I take Provigil?

Take Provigil exactly as prescribed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Do not take this medicine in larger or smaller amounts or for longer than recommended.

• Provigil may be habit-forming. Never share Provigil with another person, especially someone with a history of drug abuse or addiction.
• Keep the medication where others cannot reach it. Selling or giving away this medicine is against the law.

Provigil is usually taken 1 time each day.

• Take Provigil in the morning (when you wake up) if you suffer from daytime sleepiness due to narcolepsy or OSA.
• Take Provigil 1 hour before the start of a work shift if you are taking it to treat work-time sleep disorders.

You may take the tablet with or without food.

Provigil is usually given for 12 weeks or less.

Call your doctor if you continue to have excessive sleepiness even while taking this medicine.

• Taking Provigil does not take the place of getting enough sleep.

Keep track of the amount of medicine used from each new bottle. Provigil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Provigil for OSA

If you take Provigil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine.

• This machine is an air pump connected to a mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
• Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and Provigil may be necessary to best treat your condition.

Provigil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.

Provigil dosage

Usual Adult Dose for Narcolepsy:

• Provigil 200 mg orally daily in the morning.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

• Provigil 200 mg orally daily in the morning.

Usual Adult Dose for Shift Work Sleep Disorder:

• Provigil 200 mg orally daily one hour before the start of the work shift.

Related/similar drugs

Nuvigil, Wakix, Xyrem, Xywav, Adderall, methylphenidate, Concerta, Ritalin, modafinil, dextroamphetamine

Provigil and ADHD

Provigil is not FDA-approved for use in children for any medical condition including Attention Deficit Hyperactivity Disorder (ADHD).

Studies on children have shown potential risks outweigh any benefits. Serious skin reactions and behavioral issues have been reported. Other side effects reported when Provigil was given to children with narcolepsy included:

• Tourette’s syndrome
• hostile behavior
• increase in sudden loss of muscle tone and severe muscle weakness
• increase in seeing and hearing things when falling asleep
• increase in suicidal thoughts
• low white blood count
• painful menstrual periods.

What happens if I miss a dose?

Talk with your doctor about what to do if you miss a dose of Provigil.

Do not take a dose of Provigil if you remember your dose but it is almost bedtime or you do not plan to be awake for several hours.

• Skip the missed dose. Do not take extra medicine to make up for the missed dose the next day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Provigil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activities until you know how Provigil will affect your level of wakefulness.

Avoid drinking alcohol while taking Provigil.

What other drugs will affect Provigil?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Provigil and certain other medicines may affect each other causing possible serious side effects or affecting the way each other works. Especially tell your healthcare provider if you take:

• Medications that are substrates for CYP3A4/5 (such as contraceptives, cyclosporine, midazolam, and triazolam). These may not be as effective when taken in combination with Provigil
  • Contraceptives in particular may not be as effective while taking Provigil and for one month after discontinuing it.
• Medications that are substrates for CYP2C19 (such as phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may have their effect prolonged by Provigil, leading to an increased risk of side effects or toxicity.
• Warfarin. More frequent monitoring of prothrombin times/INR should be considered whenever Provigil is coadministered with warfarin
• Monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine. Caution should be used when concomitantly administering MAO inhibitors and Provigil.

This is not a complete list of interactions. See the Provigil Prescribing Information for more information.

Storage

Store Provigil tablets at room temperature away from moisture and heat.

Provigil ingredients

Active ingredients: modafinil 100 mg or 200 mg

Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

Available as Provigil 100 mg and Provigil 200 mg.

Who makes Provigil?

Cephalon, LLC manufactures Provigil.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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