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Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy
Author(s) -
; Fry
Publication year - 1998
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/ana.410430115
Subject(s) - modafinil , narcolepsy , somnolence , epworth sleepiness scale , excessive daytime sleepiness , psychology , placebo , cataplexy , wakefulness , sleep disorder , adverse effect , medicine , anesthesia , polysomnography , psychiatry , insomnia , electroencephalography , alternative medicine , pathology
Abstract Narcolepsy is a central nervous system disorder characterized by excessive daytime sleepiness and cataplexy. This placebocontrolled, double‐blind, randomized, parallel‐group, 18‐center study assessed the efficacy and safety of modafinil, a new wake‐promoting drug for treating sleepiness in narcolepsy. Subjects with narcolepsy (n = 283) received daily modafinil, 200 or 400 mg, or placebo, for 9 weeks, followed by an open‐label treatment period. Subjective sleepiness was measured with the Epworth Sleepiness Scale. Objective sleepiness was assessed with the 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. Medication‐related adverse expriences were few, dose‐dependent, and mostly rated mild to moderate. Modafinil taken once daily was a very well tolerated and effective wake‐promoting agent in the treatment of excessive daytime somnolence associated with narcolepsy. Modafinil demonstrated an excellent safety profile for up to 40 weeks of open‐label treatment and efficacy was maintained, suggesting that tolerance will not develop with long‐term use. Modafinil is a pharmacologically and clinically promising compound for the treatment of pathological daytime somnolence.