학술논문

A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome
Document Type
Original Paper
Source
Sleep and Breathing: International Journal of the Science and Practice of Sleep Medicine. January 2011 15(1):13-20
Subject
Xyrem/sodium oxybate
Gamma-hydroxybutyrate/GHB
Sleep apnea
Polysomnography
Slow wave sleep
Oxygen saturation
Language
English
ISSN
1520-9512
1522-1709
Abstract
Purpose:Sodium oxybate (SXB) is approved for cataplexy and excessive daytime sleepiness in narcolepsy. Obstructive sleep apnea syndrome (OSAS) affects ∼9–50% of narcoleptics. Effects of 2-week SXB administration on apnea–hypopnea index (AHI), oxygen saturation (SaO2), and sleep architecture were investigated in OSAS patients.Methods:OSAS patients (n = 48) received 2-week SXB or placebo (PBO) treatment with polysomnography at baseline and day 14. The primary outcome measure was change from baseline in mean AHI. Secondary outcomes included changes from baseline in SaO2, and sleep architecture.Results:Compared with PBO, SXB significantly increased reduction in mean AHI and obstructive apnea index with SXB (−0.8 ± 13.3 vs. −8.2 ± 10.0; p = 0.0327 and 3.54 ± 11.1 vs. −4.72 ± 7.7; p = 0.0054, respectively) and significantly increased change in slow wave sleep duration (5.2 ± 25.0 min vs. 29.4 ± 37.0 min; p = 0.0038). There were no differences between treatments in SaO2, central apneic events, or other measures. Adverse events, most commonly headache, were noted in nine of 27 (33%) and six of 23 (26%) patients receiving SXB and PBO, respectively.Conclusions:Short-term use of 4.5 g/night SXB did not generate respiratory depressant effects in OSAS patients as measured by AHI, obstructive apnea events, central apneas, and SaO2. Extended use of SXB in higher therapeutic doses in OSAS has not been studied, and merits caution.