title: Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy.
abstract: BACKGROUND
  The 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.
  
  
  OBJECTIVE
  To evaluate the benefit/risk ratio of modafinil in idiopathic hypersomnia (with and without long sleep time) vs. narcolepsy/cataplexy.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  Modafinil 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%).
  
  
  CONCLUSIONS
  Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy.
authors.affiliation: Groupe Hospitalier Pitié-Salpêtrière, Unité des Pathologies du Sommeil, Paris, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Lavault
authors.forename: Yves
authors.initials: Y
authors.lastname: Dauvilliers
authors.forename: Xavier
authors.initials: X
authors.lastname: Drouot
authors.forename: Smaranda
authors.initials: S
authors.lastname: Leu-Semenescu
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Golmard
authors.forename: Michel
authors.initials: M
authors.lastname: Lecendreux
authors.forename: Patricia
authors.initials: P
authors.lastname: Franco
authors.forename: Isabelle
authors.initials: I
authors.lastname: Arnulf
mesh_terms: D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D002385:Cataplexy / Q000188:drug therapy* / Q000453:epidemiology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects*; D015331:Cohort Studies; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020177:Idiopathic Hypersomnia / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009290:Narcolepsy / Q000188:drug therapy / Q000453:epidemiology; D018570:Risk Assessment; D012307:Risk Factors; D012890:Sleep / Q000187:drug effects; D019966:Substance-Related Disorders; D055815:Young Adult
chemical_list: D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil