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Subjects with narcolepsy (n = 283) received daily modafinil, 200 or 400 mg, or placebo, for 9 weeks, followed by an open\u2010label 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\u2010related adverse expriences were few, dose\u2010dependent, and mostly rated mild to moderate. Modafinil taken once daily was a very well tolerated and effective wake\u2010promoting agent in the treatment of excessive daytime somnolence associated with narcolepsy. Modafinil demonstrated an excellent safety profile for up to 40 weeks of open\u2010label treatment and efficacy was maintained, suggesting that tolerance will not develop with long\u2010term use. Modafinil is a pharmacologically and clinically promising compound for the treatment of pathological daytime somnolence.<\/jats:p>","DOI":"10.1002\/ana.410430115","type":"journal-article","created":{"date-parts":[[2005,1,1]],"date-time":"2005-01-01T10:10:19Z","timestamp":1104574219000},"page":"88-97","source":"Crossref","is-referenced-by-count":337,"title":["Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy"],"prefix":"10.1002","volume":"43","author":[{"family":"Fry","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"US Modafinil in Narcolepsy Multicenter Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2004,10,8]]},"reference":[{"key":"e_1_2_1_2_2","first-page":"549","volume-title":"Principles and practice of sleep medicine","author":"Guilleminault C","year":"1994"},{"key":"e_1_2_1_3_2","doi-asserted-by":"crossref","first-page":"S7","DOI":"10.1093\/sleep\/17.suppl_8.S7","article-title":"Epidemiology of narcolepsy","volume":"17","author":"Hublin C","year":"1994","journal-title":"Sleep"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/00004691-199001000-00008"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/17.suppl_8.S60"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(89)91977-6"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/17.suppl_8.S103"},{"key":"e_1_2_1_8_2","first-page":"643","volume-title":"Narcolepsy","author":"Parkes J","year":"1976"},{"key":"e_1_2_1_9_2","volume-title":"The Pharmacological basis of therapeutics","author":"Gilman AG","year":"1985"},{"key":"e_1_2_1_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3940(91)90148-M"},{"key":"e_1_2_1_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/17.5.436"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/0006-8993(92)91713-O"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/0014-2999(90)90591-S"},{"key":"e_1_2_1_14_2","first-page":"817","article-title":"Comparative effects of modafinil and amphetamine on daytime sleepiness and cataplexy of narcoleptic dogs","volume":"18","author":"Shelton J","year":"1995","journal-title":"Sleep"},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/0924-977X(95)80011-P"},{"key":"e_1_2_1_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/0028-3908(94)90115-5"},{"key":"e_1_2_1_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF02244990"},{"key":"e_1_2_1_18_2","first-page":"14128","article-title":"Potential brain neurological targets for amphetamine\u2010, methylphenidate, and modafinil\u2010induced wake\u2010fulness, evidenced by c\u2010fos immunocytochemistry in the cat","volume":"93","author":"Lin J","year":"1996","journal-title":"Neurobiology"},{"key":"e_1_2_1_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3940(95)11448-6"},{"key":"e_1_2_1_20_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF02247379"},{"key":"e_1_2_1_21_2","volume-title":"(Chairman). 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