FDA approves Provigil to improve wakefulness

Drug Store News, Feb 15, 1999

The Food and Drug Administration has approved Cephalon Inc.'s Provigil (modafinil) tablets, a non-amphetamine drug to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. The drug's efficacy was established in two Phase III, double-blind, placebo-controlled multicenter studies conducted with more than 550 patients who met the American Sleep Disorders Association criteria for narcolepsy, the chronic, lifelong neurological sleep disorder afflicting an estimated 125,000 Americans.

It is the first non-amphetamine drug indicated to treat EDS associated with narcolepsy in 40 years. Provigil will be available for prescription shortly after final scheduling is announced by the U.S. Drug Enforcement Administration, expected in mid-February. The DEA has proposed that Provigil be placed into Schedule IV of the Controlled Substances Act. The approved dosing is 200 mg, once daily.