FDA label
What is modafinil used for?
The FDA-approved uses of modafinil, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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).”
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Modafinil, tablet
Indications and Usage, quoted from the label by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (ANDA207196). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 1a309416-bd6a-45b1-982f-b689b097453d, version 14, effective September 3, 2026. NDC 23155-604, one of 48 listings for this product.
Questions
What is modafinil used for?
The FDA label says: “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).”
What drug class is modafinil?
FDA lists modafinil in the Sympathomimetic-like Agent established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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