Prescription medicine
Modafinil Brand names: Provigil
Modafinil (Provigil) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.344 per modafinil 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule IV
Check it at the source: the modafinil FDA label on DailyMed (effective October 16, 2025, Golden State Medical Supply, Inc.); the NDA 20717 record on Drugs@FDA; every modafinil label on DailyMed.
Highlights of the record
FDA label of October 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Forms and strengths
- 100 mg
- 200 mg
Tablet.
On the market
- Earliest approval on file
- December 24, 1998 Provigil, Nuvo Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first July 16, 2012; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 19 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.344 per tablet Modafinil 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 32,100 through July 30, 2026
What is modafinil used for?
From the label: indications and usagePROVIGIL 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. […]
FDA pharmacologic class: Sympathomimetic-like Agent.
Source: FDA drug label (Provigil), NDA020717 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective October 16, 2025 (SPL set 3b8d1c32-dac9-50e6-e063-6394a90aa5a5), via openFDA; the full label on DailyMed
What does the patient leaflet for modafinil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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.
From the patient leaflet: 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.
From the patient leaflet: 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.
Source: FDA drug label (Provigil), NDA020717 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective October 16, 2025 (SPL set 3b8d1c32-dac9-50e6-e063-6394a90aa5a5), via openFDA; the full label on DailyMed
Is there a generic for modafinil (Provigil)?
The FDA approved the first generic modafinil on July 16, 2012. 10 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists modafinil from 19 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for modafinil (Provigil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.344 per Modafinil 200 mg tablet, down 7% from $0.370 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Modafinil 200 mg tablet (generic)
- Provigil 200 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Modafinil 100 mg tablet | Generic | $0.248 per tablet | $7.44 | -13% |
| Modafinil 200 mg tablet | Generic | $0.344 per tablet | $10.31 | -7% |
| Provigil 100 mg tablet | Brand | $53.15 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,594.58 | +0.2% |
| Provigil 200 mg tablet | Brand | $80.35 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $2,410.48 | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has modafinil been recalled?
The FDA's Enforcement Report lists 2 recalls naming modafinil since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of modafinil and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MODAFINIL, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the modafinil label say about other medicines?
The modafinil label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name modafinil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Armodafinil | contraindications | CONTRAINDICATIONS PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )]. |
| Clomipramine | drug interactions | 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. |
| Cyclosporine | drug interactions | DRUG 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. |
| Diazepam | drug interactions | 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. |
| Midazolam | drug interactions | DRUG 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. |
| Omeprazole | drug interactions | 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. |
| Phenytoin | drug interactions | 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. |
| Propranolol | drug interactions | 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. |
| Triazolam | drug interactions | DRUG 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. |
| Warfarin | drug interactions | Warfarin More frequent monitoring of prothrombin times/INR should be considered whenever PROVIGIL is coadministered with warfarin [see Clinical Pharmacology ( 12.3 )]. |
Other labels that name modafinil
Source: FDA drug label (Provigil), NDA020717 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective October 16, 2025 (SPL set 3b8d1c32-dac9-50e6-e063-6394a90aa5a5), via openFDA; the full label on DailyMed
What do FAERS reports show for modafinil?
The FDA Adverse Event Reporting System holds 32,100 reports that list modafinil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,070 are coded as a death and 6,829 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (5,872, against a median of 1,338 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Modafinil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other