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. SUBJECTS AND 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%). CONCLUSION: Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy.
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. SUBJECTS AND 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 narcolepsypatients (-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 narcolepsypatients: nervousness (14%), palpitations (13%), and headache (11%). CONCLUSION:Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy.
Authors: Christian R Baumann; Emmanuel Mignot; Gert Jan Lammers; Sebastiaan Overeem; Isabelle Arnulf; David Rye; Yves Dauvilliers; Makoto Honda; Judith A Owens; Giuseppe Plazzi; Thomas E Scammell Journal: Sleep Date: 2014-06-01 Impact factor: 5.849
Authors: Chad Ruoff; Fabio Pizza; Lynn Marie Trotti; Karel Sonka; Stefano Vandi; Joseph Cheung; Swaroop Pinto; Mali Einen; Narong Simakajornboon; Fang Han; Paul Peppard; Sona Nevsimalova; Giuseppe Plazzi; David Rye; Emmanuel Mignot Journal: J Clin Sleep Med Date: 2018-01-15 Impact factor: 4.062