modafinil

FDA Drug Profile — Provigil, Modafinil, modafinil

Drug Details

Generic Name
modafinil
Brand Names
Provigil, Modafinil, modafinil
Application Number
NDA020717
Sponsor
Wavelength Enterprises LTD
NDC Codes
14
Dosage Forms
POWDER, TABLET
Routes
ORAL
Active Ingredients
MODAFINIL

Indications and Usage

Armodafinil tablets are 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, armodafinil 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 armodafinil tablets for excessive sleepiness.