FDA label
What is Provigil used for?
Provigil contains modafinil. The FDA-approved uses below are 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: “PROVIGIL is 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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Provigil, tablet
Indications and Usage, quoted from the label by Apotex Corp (NDA020717). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 0391f182-1958-9fef-a944-53b229ce99e7, version 4, effective August 27, 2025. NDC 60505-4851, one of 5 listings for this product.
Questions
What is Provigil used for?
The FDA label says: “PROVIGIL is 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 Provigil?
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.
More on Provigil
- Is Provigil a controlled substance?Schedule IV
- Generic for ProvigilFDA Orange Book
- What is Modafinil used for?FDA label uses
- Is Modafinil a controlled substance?Schedule IV
- Sympathomimetic-like Agents listFDA drug class
- NDC 60429-009Provigil NDC record
- NDC 60429-010Provigil NDC record
- NDC 60505-4851Provigil NDC record
- Schedule IV drugs listDEA schedule