December 28, 1998: Today Cephalon announced that the US Food and Drug Administration (FDA) granted approval for them to market Provigil®, their modafinil tablets. Modafinil has been successfully used to treat excessive daytime sleepiness (EDS) in people with narcolepsy in Canada and Europe for years.
After two years of hearing that this drug will be available "real soon now" we hear it again -- but this time with feeling. Don't go running to the store, just yet. PROVIGIL will only be available by prescription after final scheduling is announced by the U.S. Drug Enforcement Administration (DEA). The DEA has proposed that PROVIGIL be placed into Schedule IV of the Controlled Substances Act. Some news reports indicate that this date may be as early as Febuary 15.
While the clinical tests used both 200 and 400mg treatments, the FDA approved dosing is only 200 mg once daily.
Modafinil has very few side effects and therefore is superior to existing drug treatments for EDS (amphetamines). For people with mild to moderate EDS, modafinil promises to greatly help them. It is no panacea and those people with severe narcolepsy and idiopathic hypersomnia may not get much more relief with modafinil -- especially at 200mg/day.
Modafinil does not treat cataplexy -- the most disabilitating symptom of narcolepsy. Presently, Orphan Medical is experimenting with a promising treatment for cataplexy.
Provigil is a registered trademark of Cephalon Inc.