Prescription medicine
Armodafinil Brand names: Nuvigil
Armodafinil (Nuvigil) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.788 per armodafinil 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule IV
Check it at the source: the armodafinil FDA label on DailyMed (effective September 2, 2025, Golden State Medical Supply, Inc.); the NDA 21875 record on Drugs@FDA; every armodafinil label on DailyMed.
Highlights of the record
FDA label of September 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageNUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
Forms and strengths
- 50 mg
- 150 mg
- 200 mg
- 250 mg
Tablet.
On the market
- Earliest approval on file
- June 15, 2007 Nuvigil, Nuvo Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first June 1, 2012; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 7 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.788 per tablet Armodafinil 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 20,967 through July 30, 2026
What is armodafinil used for?
From the label: indications and usageNUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, NUVIGIL 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 NUVIGIL for excessive sleepiness. […]
Source: FDA drug label (Nuvigil), NDA021875 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective September 2, 2025 (SPL set 3dd49302-f757-d945-e063-6294a90afcba), via openFDA; the full label on DailyMed
What does the patient leaflet for armodafinil 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 NUVIGIL?NUVIGIL is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep NUVIGIL in a safe place to prevent misuse and abuse. Selling or giving away NUVIGIL may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. NUVIGIL 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 NUVIGIL 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, breathing, or hoarseness fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of theeyes, or dark urine. If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured. NUVIGIL is not approved for use in children for any medical condition. It is not known if NUVIGIL is safe and effective in children under the age of 18.
From the patient leaflet: What should I avoid while taking NUVIGIL?Do not drive a car or do other dangerous activities until you know how NUVIGIL 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 NUVIGIL.
From the patient leaflet: How should I store NUVIGIL?Store NUVIGIL at room temperature between 68°F to 77°F (20°C to 25°C). Keep NUVIGIL and all medicines out of the reach of children.
Source: FDA drug label (Nuvigil), NDA021875 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective September 2, 2025 (SPL set 3dd49302-f757-d945-e063-6294a90afcba), via openFDA; the full label on DailyMed
Is there a generic for armodafinil (Nuvigil)?
The FDA approved the first generic armodafinil on June 1, 2012. 6 generic applications are approved; 4 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 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists armodafinil from 7 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.
- 2007 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for armodafinil (Nuvigil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.788 per Armodafinil 150 mg tablet, about the same as a year earlier. 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.
- Armodafinil 50 mg tablet (generic)
- Nuvigil 150 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Armodafinil 150 mg tablet | Generic | $0.788 per tablet | $23.63 | +0.2% |
| Armodafinil 200 mg tablet | Generic | $0.803 per tablet | $24.08 | -2% |
| Armodafinil 250 mg tablet | Generic | $0.908 per tablet | $27.25 | +0.8% |
| Armodafinil 50 mg tablet | Generic | $0.306 per tablet | $9.17 | -1% |
| Nuvigil 150 mg tablet | Brand | $34.75 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,042.56 | -0.4% |
| Nuvigil 200 mg tablet | Brand | $35.06 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,051.87 | +0.5% |
| Nuvigil 250 mg tablet | Brand | $34.77 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,043.15 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the armodafinil label say about other medicines?
The armodafinil label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name armodafinil. 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 |
|---|---|---|
| Clomipramine | drug interactions | Effects of NUVIGIL on CYP2C19 Substrates Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. |
| Cyclosporine | drug interactions | DRUG INTERACTIONS Effects of NUVIGIL 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 NUVIGIL via induction of metabolic enzymes, which results in lower systemic exposure. |
| Diazepam | drug interactions | Effects of NUVIGIL on CYP2C19 Substrates Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. |
| Midazolam | drug interactions | DRUG INTERACTIONS Effects of NUVIGIL 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 NUVIGIL via induction of metabolic enzymes, which results in lower systemic exposure. |
| Modafinil | contraindications | CONTRAINDICATIONS NUVIGIL 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 )]. |
| Omeprazole | drug interactions | Effects of NUVIGIL on CYP2C19 Substrates Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. |
| Phenytoin | drug interactions | Effects of NUVIGIL on CYP2C19 Substrates Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. |
| Propranolol | drug interactions | Effects of NUVIGIL on CYP2C19 Substrates Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. |
| Triazolam | drug interactions | DRUG INTERACTIONS Effects of NUVIGIL 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 NUVIGIL 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 NUVIGIL is coadministered with warfarin [see Clinical Pharmacology (12.3)]. |
Other labels that name armodafinil
Source: FDA drug label (Nuvigil), NDA021875 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective September 2, 2025 (SPL set 3dd49302-f757-d945-e063-6294a90afcba), via openFDA; the full label on DailyMed
What do FAERS reports show for armodafinil?
The FDA Adverse Event Reporting System holds 20,967 reports that list armodafinil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 325 are coded as a death and 2,534 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 (5,261, against a median of 681 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?
- Armodafinil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other