Authors' objectives:

To summarise the currently available evidence on sodium oxybate (Xyrem) for cataplexy and excessive daytime sleepiness in narcolepsy.

Authors' recommendations: Sodium oxybate (Xyrem, gamma-hydroxybutyrate, GHB) is a central nervous system depressant with anti-cataplectic activity for the management of cataplexy in patients with narcolepsy. Results from a short-term double-blind randomised, placebo-controlled phase III trial in 136 patients demonstrated a median reduction in the number of cataplexy attacks of between 49% and 69%. Statistical significance was also demonstrated in the reduction in daytime sleepiness, the frequency of inadvertent sleep attacks and night-time awakenings at the higher dose. Long-term efficacy and lack of dependence was demonstrated in a 12-month open label phase III trial. Sodium oxybate is also in ongoing phase III trials for excessive daytime sleepiness (EDS) in narcolepsy, with and without concomitant stimulants.

Authors' methods: Overview

Project Status: Completed

Year Published: 2004

URL for published report: http://www.psy-flow.com/sites/psy-flow/files/docs/flow.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: National Horizon Scanning Centre (NHSC)