Background: To assess the effectiveness and safety of modafinil vs. no active treatment or other drugs in the treatment of narcolepsy.
Material/Methods: The following electronic databases were searched throughout January 2009: MEDLINE, EMBASE and The Cochrane Library. Additional references were obtained from reviewed articles. Only randomized controlled trials were included.
Results: We included 9 trials involving 1,054 patients in the study. Modafinil in comparison with placebo brings significant benefit in terms of elimination of excessive daytime sleepiness assessed by: ESS scale – weighted mean difference (WMD) –2.73 points (95%CI –3.39, –2.08), MSLT test – WMD 1.11 minutes (95%CI 0.55, 1.66) and MWT test – WMD 2.82 minutes (95%CI 2.40, 3.24), as well as the number and duration of somnolence, sleep attacks and naps per day, but was not different from placebo in the number of attacks of cataplexy per day. Modafinil in comparison with placebo improved quality of life of narcoleptic patients according to SF-36 questionnaire, but was associated with more common nausea. It had similar effect on excessive daytime sleepiness as sodium oxybate and was associated with less common nausea.
Conclusions: In narcoleptic patients, modafinil in comparison with placebo is effective in the treatment of excessive daytime sleepiness, but not cataplexy.

Keywords: Placebos, Neuroprotective Agents - therapeutic use, Narcolepsy - drug therapy, Benzhydryl Compounds - therapeutic use, Adolescent, young adult