RANDOMIZED TRIAL OF MODAFINIL FOR THE TREATMENT OF PATHOLOGICAL SOMNOLENCE IN NARCOLEPSY

Narcolepsy is a central nervous system disorder characterized by exces sive daytime sleepiness and cataplexy. This placebo-controlled, double -blind, randomized, parallel-group, 18-center study assessed the effic acy and safety of modafinil, a new wake-promoting drug for treating sl eepiness in narcolepsy. Subjects with narcolepsy (n = 283) received da ily modafinil, 200 or 400 mg, or placebo, for 9 weeks, followed by an open-label treatment period. Subjective sleepiness was measured with t he Epworth Sleepiness Scale. Objective sleepiness was assessed with th e Multiple Sleep Latency Test and the Maintenance of Wakefulness Test. Level of illness was measured with the Clinical Global Impression of Change. Modafinil significantly reduced all measures of sleepiness and was associated with significant improvements in level of illness. Med ication-related adverse experiences were few, dose-dependent, and most ly rated mild to moderate. Modafinil taken once daily was a very well tolerated and effective wake-promoting agent in the treatment of exces sive daytime somnolence associated with narcolepsy. Modafinil demonstr ated an excellent safety profile for up to 40 weeks of open-label trea tment and efficacy was maintained, suggesting that tolerance will not develop with long-term use. Modafinil is a pharmacologically and clini cally promising compound for the treatment of pathological daytime som nolence.