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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2014 | Original application | Approved | None posted |
| Jun 21, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 11, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 11, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 3, 2014 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
