Brand Name
Provigil
Generic Name
Modafinil
View Brand Information FDA approval date: December 24, 1998
Classification: Sympathomimetic-like Agent
Form: Tablet
What is Provigil (Modafinil)?
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea , or shift work disorder . Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure 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 indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea , or shift work disorder . Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
Approved To Treat
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Brand Information
Provigil (Modafinil)
1INDICATIONS AND USAGE
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Limitations of Use
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.
2DOSAGE FORMS AND STRENGTHS
- 100 mg – capsule-shaped, white to off white, tablet, debossed with "PROVIGIL" on one side and "100 MG" on the other.
- 200 mg – capsule-shaped, white to off white, scored, tablet, debossed with "PROVIGIL" on one side and "200 MG" on the other.
3CONTRAINDICATIONS
PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Serious Rash, including Stevens-Johnson Syndrome
- Angioedema and Anaphylaxis Reactions
- Multi-organ Hypersensitivity Reactions
- Persistent Sleepiness
- Psychiatric Symptoms
- Effects on Ability to Drive and Use Machinery
- Cardiovascular Events
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
PROVIGIL has been evaluated for safety in over 3,500 patients, of whom more than 2,000 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.
Most Common Adverse Reactions
In placebo-controlled clinical trials, the most common adverse reactions (≥ 5%) associated with the use of PROVIGIL more frequently than placebo-treated patients were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse reaction profile was similar across these studies.
Table 1 presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in PROVIGIL-treated patients than in placebo-treated patients in the placebo-controlled clinical trials.
Dose-Dependent Adverse Reactions
In the placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of PROVIGIL and placebo, the following adverse reactions were dose related: headache and anxiety.
Adverse Reactions Resulting in Discontinuation of Treatment
In placebo-controlled clinical trials, 74 of the 934 patients (8%) who received PROVIGIL discontinued due to an adverse reaction compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for PROVIGIL than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain, and nervousness (each <1%).
Laboratory Abnormalities
Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of PROVIGIL, but not placebo. Few patients, however, had GGT or AP elevations outside of the normal range. Shifts to higher, but not clinically significantly abnormal, GGT and AP values appeared to increase with time in the population treated with PROVIGIL in the placebo-controlled clinical trials. No differences were apparent in alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, or total bilirubin.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of PROVIGIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hematologic: agranulocytosis
Psychiatric disorders: psychomotor hyperactivity
5DRUG INTERACTIONS
Effects of PROVIGIL on CYP3A4/5 Substrates
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.
Effects of PROVIGIL on CYP2C19 Substrates
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
Warfarin
More frequent monitoring of prothrombin times/INR should be considered whenever PROVIGIL is coadministered with warfarin
Monoamine Oxidase (MAO) Inhibitors
Caution should be used when concomitantly administering MAO inhibitors and PROVIGIL.
6OVERDOSAGE
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.
7DESCRIPTION
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.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Allergic Reactions
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.
Driving and Dangerous Activities
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.
Continuing Previously Prescribed Treatments
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).
Discontinuing Drug Due to Adverse Reactions
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.
Pregnancy
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.
Nursing
Advise patients to notify their physician if they are breastfeeding an infant.
Concomitant Medication
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.
Alcohol
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.
9MEDICATION GUIDE
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.
What is the most important information I should know about PROVIGIL?
PROVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening.
Stop taking PROVIGIL and call your doctor right away or get emergency help if you have any of these symptoms:
- skin rash, hives, sores in your mouth, or your skin blisters and peels
- swelling of your face, eyes, lips, tongue, or throat
- trouble swallowing or breathing
- fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine
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.
PROVIGIL is not approved for use in children for any medical condition.
It is not known if PROVIGIL is safe or effective in children under 17 years of age.
What is PROVIGIL?
PROVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:
- narcolepsy
- obstructive sleep apnea (OSA). PROVIGIL is used to treat excessive sleepiness, but not the obstruction or medical condition that is causing OSA. You should talk with your doctor about treatments for OSA before you start taking PROVIGIL and during treatment with PROVIGIL. PROVIGIL does not take the place of treatments that your doctor has prescribed for OSA. It is important that you continue to use these treatments as prescribed by your doctor.
- shift work disorder (SWD)
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.
Who should not take PROVIGIL?
Do not take PROVIGIL if you:
- are allergic or developed a rash to modafinil or armodafinil (NUVIGIL
What should I tell my doctor before taking PROVIGIL?
Tell your doctor about all of your medical conditions including, if you:
- have a history of mental health problems, including psychosis
- have heart problems or had a heart attack
- have high blood pressure. Your blood pressure may need to be checked more often while taking PROVIGIL.
- have liver or kidney problems
- have a history of drug or alcohol abuse or addiction
- are pregnant or planning to become pregnant. It is not known if PROVIGIL will harm your unborn baby.
- are breastfeeding. It is not known if PROVIGIL passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take PROVIGIL.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PROVIGIL and many other medicines can interact with each other, sometimes causing side effects. PROVIGIL may affect the way other medicines work, and other medicines may affect how PROVIGIL works. Your dose of PROVIGIL or certain other medicines may need to be changed.
Especially, tell your doctor if you use or take:
- a hormonal birth control method, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs). Hormonal birth control methods may not work while you take PROVIGIL. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking PROVIGIL, and for one month after stopping PROVIGIL. Talk to your doctor about birth control choices that are right for you while taking PROVIGIL.
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.
How should I take PROVIGIL?
- Take PROVIGIL exactly as prescribed by your doctor. Your doctor will prescribe the dose of PROVIGIL that is right for you. Do not change your dose of PROVIGIL without talking to your doctor.
- Your doctor will tell you the right time of day to take PROVIGIL.
- Do not change the time of day you take PROVIGIL unless you have talked to your doctor. If you take PROVIGIL too close to your bedtime, you may find it harder to go to sleep.
- You can take PROVIGIL with or without food.
- If you take more than your prescribed dose or if you take an overdose of PROVIGIL, call your doctor or go to the nearest hospital emergency room right away.
Symptoms of an overdose of PROVIGIL may include:
- trouble sleeping
- restlessness
- confusion
- feeling disoriented
- feeling excited
- hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
- nausea and diarrhea
- a fast or slow heartbeat
- chest pain
- increased blood pressure
What should I avoid while taking PROVIGIL?
- Do not drive a car or do other dangerous activities until you know how PROVIGIL affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.
- You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking PROVIGIL.
What are possible side effects of PROVIGIL?
PROVIGIL may cause serious side effects. Stop taking PROVIGIL and call your doctor right away or get emergency help if you get any of the following:
- a serious rash or serious allergic reaction. (See “What is the most important information I should know about PROVIGIL?”)
- mental (psychiatric) symptoms, including:
- depression
- feeling anxious
- hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
- an extreme increase in activity and talking (mania)
- thoughts of suicide
- aggressive behavior
- other mental problems
- symptoms of a heart problem, including chest pain, abnormal heartbeat, and trouble breathing.
Common side effects that can happen in anyone who takes PROVIGIL include:
PROVIGIL is not approved for use in children for any medical condition including Attention Deficit Hyperactivity Disorder (ADHD). In studies of PROVIGIL in children with narcolepsy, side effects 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
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.
How should I store PROVIGIL?
- Store PROVIGIL at room temperature between 68°F and 77°F (20°C and 25°C).
- Keep PROVIGIL and all medicines out of the reach of children.
General information about the safe and effective use of PROVIGIL.
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
What are the ingredients in PROVIGIL?
Active Ingredient: modafinil
Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.
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
10Package/Label Display Panel
NDC 60505-4851-3
11Package/Label Display Panel
NDC 60505-4852-3
