• Sophie Lavault, Yves Dauvilliers, Xavier Drouot, Smaranda Leu-Semenescu, Jean-Louis Golmard, Michel Lecendreux, Patricia Franco, and Isabelle Arnulf.
• Groupe Hospitalier Pitié-Salpêtrière, Unité des Pathologies du Sommeil, Paris, France.
• Sleep Med. 2011 Jun 1;12(6):550-6.

BackgroundThe benefit/risk ratio of modafinil was recently re-evaluated by the European Medicines Agency and was shown to be negative for idiopathic hypersomnia (IH) because of insufficient data.ObjectiveTo evaluate the benefit/risk ratio of modafinil in idiopathic hypersomnia (with and without long sleep time) vs. narcolepsy/cataplexy.Subjects And MethodsThe benefit (Epworth sleepiness score, ESS; visual analog scale, patient and clinician opinions) and risks (habituation, adverse effects) of modafinil were studied in a consecutive clinical cohort of 104 IH patients (59 with long sleep time) and 126 patients with narcolepsy/cataplexy.ResultsModafinil was the first line treatment in 96-99% of patients. It produced a similar ESS change in IH patients and in narcolepsy patients (-2.6±5.1 vs. -3±5.1) and a similar benefit as estimated by the patients (6.9±2.7 vs. 6.5±2.5 on a visual analog scale) and clinicians. The ESS change was lower in IH patients with long sleep time than in those without. Sudden loss of efficacy and habituation were rare in both groups. Patients with IH reported similar but more frequent adverse effects with modafinil than narcolepsy patients: nervousness (14%), palpitations (13%), and headache (11%).ConclusionModafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy.Copyright © 2011 Elsevier B.V. All rights reserved.

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