Statement of Significance
sleep behavior disorder, sleep-related injuries, RBD
REM sleep behavior disorder (RBD) is the leading cause of sleep-related injuries but there is currently no symptomatic therapy approved by the Federal Drug Administration. This study is among the rare randomized clinical trials in RBD and the first controlled study using sodium oxybate. This double-blind placebo-controlled study suggests that sodium oxybate may plausibly be effective, not only per patients' report, but per objective video-polysomnography measures. Our findings provide the basis for future larger studies evaluating the efficacy of sodium oxybate in RBD. Importantly, our protocol is the first to implement guidelines from the International RBD Study Group on clinical trials and outcome measures in RBD and use objective endpoints.