Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder.

Abstract

STUDY OBJECTIVES:

Symptomatic therapies for rapid-eye-movement (REM) sleep behavior disorder (RBD) are limited. Sodium oxybate (SXB), a gamma-aminobutyric acid (GABA)-B agonist, could be effective but has not been evaluated against placebo.

METHODS:

This double-blind, parallel-group, randomized, placebo-controlled trial in 24 participants was conducted at the Stanford Sleep Center. Patients were adults with definite iRBD or Parkinson's disease and probable RBD (PD-RBD), and persistence of ≥ 2 weekly episodes despite standard therapy. Patients were randomized 1:1 to receive SXB during a 4-week titration followed by a 4-week stable dosing period. Primary outcome was number of monthly RBD episodes according to a diary filled by patients and partners. Secondary outcomes were severity, number of severe RBD episodes, and objective RBD activity on video polysomnography.

RESULTS:

Twelve iRBD and 12 PD-RBD participated (mean 65.8 years), and 22 (n = 10 SXB, 12 placebo) completed the study. Although no significant between-group difference was found, SXB showed reduction of monthly RBD episodes by 23.1 (95% CI -36.0, -10.2; p = 0.001) versus 10.5 with placebo (95% CI, -22.6, 1.6; p = 0.087). Improvement from baseline was similarly observed for RBD overall severity burden (each episode weighted for severity), number of severe episodes, and objective RBD activity per video-polysomnography. Two participants receiving SXB withdrew due to anxiety and dizziness. The majority of adverse events are otherwise resolved with dose adjustment.

CONCLUSION:

SXB could reduce RBD symptoms; however, response was inconsistent and a large placebo effect was observed across patient-reported outcomes. Larger studies using objective endpoints are needed.

CLINICAL TRIAL:

Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate https://clinicaltrials.gov/ct2/show/NCT04006925 ClinicalTrials.gov identifier: NCT04006925.

• Authors: Emmanuel H During, Beatriz Hernandez, Mitchell G Miglis, Oliver Sum-Ping, Anahid Hekmat, Ana Cahuas, Adrian Ekelmans, Fuyumi Yoshino, Emmanuel Mignot, Clete A Kushida
• Journal: Sleep (Sleep) Vol. 46 Issue 8 (08 14 2023) ISSN: 1550-9109 [Electronic] United States
• PMID: 37052688 (Publication Type: Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Sleep Research Society 2023. Published by Oxford University Press on behalf of the Sleep Research Society.

Chemical References

• Sodium Oxybate

Topics

• Adult
• Humans
• REM Sleep Behavior Disorder (complications, drug therapy)
• Sodium Oxybate (therapeutic use)
• Sleep
• Anxiety
• Anxiety Disorders