A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome.
OBJECTIVE
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 (SaO(2)), 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 SaO(2), 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.
George
Charles F P
CF
University of Western Ontario, London Health Sciences Centre, 375 South Street, London, ON, N6A 4G5, Canada. Charles.George@LHSC.ON.CA
Feldman
Neil
N
Zheng
Yanping
Y
Steininger
Teresa L
TL
Grzeschik
Susanna M
SM
Lai
Chinglin
C
Inhaber
Neil
N
D000759:Adjuvants, Anesthesia / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy; D045422:Continuous Positive Airway Pressure; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D017286:Polysomnography / Q000187:drug effects*; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use; D020181:Sleep Apnea, Obstructive / Q000188:drug therapy*; D012978:Sodium Oxybate / Q000009:adverse effects / Q000627:therapeutic use*; D000077334:Zolpidem
D000759:Adjuvants, Anesthesia; D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D006993:Hypnotics and Sedatives; D011725:Pyridines; D012978:Sodium Oxybate; D000077334:Zolpidem; D000077408:Modafinil