A safety trial of sodium oxybate in patients with obstructive sleep apnea: Acute effects on sleep-disordered breathing

Objective: Sodium oxybate (SXB) is an approved drug for the treatment of excessive daytime sleepiness (EDS) and cataplexy in narcolepsy. Obstructive sleep apnea syndrome (OSAS) is a condition that frequently co-occurs with narcolepsy. Given the known central nervous system (CNS) depressant effects of SXB, this Study aimed to examine its effects on sleep-disordered breathing (SDB) and sleep architecture in patients with OSAS. Methods: Sixty patients with a history of mild to moderate OSAS (apnea-hypopnea index [AHI] >= Wand <= 40, mean oxygen saturation [SaO(2)] >= 75%) received one Of four treatments of the following: (1) 9 g SXB, (2) 9 g SXB/modafinil 200 mg, (3) zolpidem 10 rug, and (4) placebo (PBO) in a randomized, crossover design on four consecutive nights followed by overnight polysomnography. Results: Forty-two patients (70%) completed the study. The mean change from baseline in AHI and mean SaO(2) was not significantly different among groups following treatment. Central apneas in patients treated with SXB increased, and clinically significant oxygen desaturations were seen in three patients with SXB treatment. The most common treatment related adverse events were headache and nausea. Conclusion: These results suggest that nighttime administration of 9 g SXB in patients with mild to moderate OSAS does not negatively impact SDB, as measured by mean change from baseline in AHI and SaO(2), but might increase central apneas and cause oxygen desaturation in some individuals and should be used with caution. (C) 2009 Elsevier B.V. All rights reserved.