Finished product reference
Modafinil
Tablet · Oral · 100 mg
- List code
- 6579
- Pharmacologic class
- Sympathomimetic-like Agent
Indications
Modafinil tablets are 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, modafinil tablets are 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 modafinil tablets for excessive sleepiness. Modafinil tablets are 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, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
Dosage and administration (summary)
The recommended dosage of modafinil tablets for each indication is as follows: Narcolepsy or OSA: 200 mg once a day in the morning. SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift. Severe Hepatic Impairment: reduce dose to half the recommended dose. ( 2.3 , 12.3 ) Geriatric Patients: consider lower dose. ( 2.4 , 12.3 ) Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA) The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.
Contraindications
Modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients . Modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil.
Warnings and precautions
Serious Rash, including Stevens-Johnson Syndrome: Discontinue modafinil tablets at the first sign of rash, unless the rash is clearly not drug-related. Angioedema and Anaphylaxis Reactions: If suspected, discontinue modafinil tablets. Multi-organ Hypersensitivity Reactions: If suspected, discontinue modafinil tablets. Persistent Sleepiness: Assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity.
Storage and supply
How Supplied Modafinil Tablets, USP are supplied as follows: 100 mg White, round, biconvex tablets, engraved "MOD" over "100" on one side, "APO" on the other side. NDC 51407-928-30 - Bottles of 30 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) . Dispense in tight, light-resistant container .
Source: Modafinil (Modafinil) — US FDA prescribing information, 2026-03-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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