PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness.

PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients

The following serious adverse reactions are described elsewhere in the labeling:

The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by PROVIGIL via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with PROVIGIL

The effectiveness of steroidal contraceptives may be reduced when used with PROVIGIL and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with PROVIGIL and for one month after discontinuation of PROVIGIL treatment.

Blood levels of cyclosporine may be reduced when used with PROVIGIL. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with PROVIGIL.

Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by PROVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. In individuals deficient in the CYP2D6 enzyme, the levels of CYP2D6 substrates which have ancillary routes of elimination through CYP2C19, such as tricyclic antidepressants and selective serotonin reuptake inhibitors, may be increased by co-administration of PROVIGIL. Dose adjustments of these drugs and other drugs that are substrates for CYP2C19 may be necessary when used concomitantly with PROVIGIL

More frequent monitoring of prothrombin times/INR should be considered whenever PROVIGIL is coadministered with warfarin

Caution should be used when concomitantly administering MAO inhibitors and PROVIGIL.

In clinical trials, a total of 151 protocol-specified doses ranging from 1000 to 1600 mg/day (5 to 8 times the recommended daily dose of PROVIGIL) have been administered to 32 subjects, including 13 subjects who received doses of 1000 or 1200 mg/day for 7 to 21 consecutive days. In addition, several intentional acute overdoses occurred; the two largest being 4500 mg and 4000 mg taken by two subjects participating in foreign depression studies. None of these study subjects experienced any unexpected or life-threatening effects. Adverse reactions that were reported at these doses included excitation or agitation, insomnia, and slight or moderate elevations in hemodynamic parameters. Other observed high-dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea, and decreased prothrombin time.

From postmarketing experience, there have been reports of fatal overdoses involving modafinil alone or in combination with other drugs. Symptoms most often accompanying PROVIGIL overdose, alone or in combination with other drugs have included insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, agitation, anxiety, excitation, and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.

Cases of accidental ingestion/overdose have been reported in children as young as 11 months of age. The highest reported accidental ingestion on a mg/kg basis occurred in a three-year-old boy who ingested 800-1000 mg (50-63 mg/kg) of PROVIGIL. The child remained stable. The symptoms associated with overdose in children were similar to those observed in adults.

No specific antidote exists for the toxic effects of a PROVIGIL overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.

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 C

The chemical structure is:

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

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Advise patients to stop taking PROVIGIL and to notify their physician right away if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing, or a related allergic phenomenon.

Advise patients not to alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with PROVIGIL has been shown to produce levels of wakefulness that permit such activities. Advise patients that PROVIGIL is not a replacement for sleep.

Inform patients that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSA receiving CPAP should continue to do so).

Advise patients to stop taking PROVIGIL and contact their physician right away if they experience chest pain, rash, depression, anxiety, or signs of psychosis or mania.

Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Caution patients regarding the potential increased risk of pregnancy when using steroidal contraceptives (including depot or implantable contraceptives) with PROVIGIL and for one month after discontinuation of therapy.

Advise patients to notify their physician if they are breastfeeding an infant.

Advise patients to inform their physician if they are taking, or plan to take, any prescription or over‑the‑counter drugs, because of the potential for interactions between PROVIGIL and other drugs.

Advise patients that the use of PROVIGIL in combination with alcohol has not been studied. Advise patients that it is prudent to avoid alcohol while taking PROVIGIL.

Dispense with Medication Guide available at

Manufactured for:

33326 USA

All rights reserved.

PROVIGIL

Medication Guide available at

Read this Medication Guide before you start taking PROVIGIL and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

If you have a severe rash with PROVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.

It is not known if PROVIGIL is safe or effective in children under 17 years of age.

PROVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

PROVIGIL will not cure these sleep disorders. PROVIGIL may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. PROVIGIL does not take the place of getting enough sleep. Follow your doctor's advice about good sleep habits and using other treatments.

Especially, tell your doctor if you use or take:

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. Your doctor or pharmacist will tell you if it is safe to take PROVIGIL and other medicines together. Do not start any new medicines with PROVIGIL unless your doctor has told you it is okay.

Symptoms of an overdose of PROVIGIL may include:

Common side effects that can happen in anyone who takes PROVIGIL include:

Tell your doctor if you get any side effect that bothers you or that does not go away while taking PROVIGIL.

These are not all the side effects of PROVIGIL. For more information, ask your doctor or pharmacist.

Some effects of PROVIGIL on the brain are the same as other medicines called “stimulants”. These effects may lead to abuse or dependence on PROVIGIL.

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROVIGIL for a condition for which it was not prescribed. Do not give PROVIGIL to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about PROVIGIL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about PROVIGIL that is written for health professionals. For more information, call 1-800-706-5575

Manufactured for:

33326 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

All rights reserved

ApoPharma is a registered trademark of Apotex Inc.

Revised: February 2025

NDC 60505-4851-3

NDC 60505-4852-3