A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy SLEEP Black, J., Guilleminault, C., Bogan, R., Feldman, N., Hagaman, M., Hertz, G., Iyer, V., Kathawalla, S., Lankford, A., Mitler, M., Hayduk, R., Sahota, P., Roth, T., Scharf, M., Scrima, L., SCHWARTZ, J., Zammit, G. 2003; 26 (1): 31-35


To evaluate the long-term safety and efficacy of nightly sodium oxybate for the treatment of narcolepsy.A multicenter, 12-month, open-label trial.118 narcolepsy patients previously enrolled in a 4-week double-blind sodium oxybate trial. Interventions: Patients were administered 6 g sodium oxybate nightly, taken in equally divided doses at bedtime and 2.5 to 4 hours later. The study protocol permitted the dose to be increased or decreased in 1.5-g increments at 2-week intervals based on efficacy response or adverse experiences but staying within the range of 3 to 9 g nightly.Narcolepsy symptoms and adverse events were recorded in daily diaries. Safety measures included physical and laboratory examinations repeated at 6 and 12 months. The primary efficacy measure was the change in weekly cataplexy attacks from baseline. Secondary measures included daytime sleepiness using the Epworth Sleepiness Scale (ESS), inadvertent naps/sleep attacks, nighttime awakenings, and the overall change in disease severity as rated by the investigators (Clinical Global Impression of Change; CGI-c).Sodium oxybate, in doses of 3 to 9 g nightly, produced overall improvements in narcolepsy symptoms, which were significant at 4 weeks and maximal after 8 weeks. Reported improvements included a significant decrease in frequency of cataplexy attacks (p < 0.001); diminished daytime sleepiness (p < 0.001); and patient descriptions of nocturnal sleep quality, level of alertness, and ability to concentrate (for each p < 0.001). Adverse events were generally mild and patients showed no evidence of tolerance.Sodium oxybate is an effective and well-tolerated treatment for narcolepsy.

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View details for PubMedID 12627729