Once‐Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy

作者：Luis E. Ortiz, Anne Marie Morse, Michael J. Thorpy, Clete A. Kushida, John Harsh, Thomas Roth, Jennifer Gudeman, Yves Dauvilliers · 发表于：Journal of Sleep Research · 年份：2025 · DOI：10.1111/jsr.70189 · 被引用次数：1 · 研究领域：Sleep and Wakefulness Research、Sleep and related disorders、Restless Legs Syndrome Research

Data from the REST-ON trial were not available before the 2021 American Academy of Sleep Medicine (AASM) clinical practice guideline update, which included a literature review through August 2020. This post hoc analysis from REST-ON assessed participants who achieved clinically significant improvements on individual AASM clinical significance thresholds (CSTs). Composites of the coprimary endpoints and a secondary endpoint were also analysed. Participants with narcolepsy aged ≥ 16 years were randomised 1:1 to once-nightly sodium oxybate (ON-SXB) or placebo for 13 weeks. Coprimary endpoints were mean sleep latency on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression of Improvement (CGI-I) rating, and number of cataplexy episodes; secondary endpoints included the Epworth Sleepiness Scale (ESS) score. Outcomes with ON-SXB treatment compared with baseline were assessed according to the CSTs, and for those who met CSTs, the proportions of participants who experienced clinically significant improvements on a composite of ≥ 2, ≥ 3, or 4 endpoints were calculated. For improvements from baseline with ON-SXB at Week 13 (9-g dose), mean sleep latency on the MWT increased 10.8 min (CST, ≥ 2-min increase), 92.8% rated improvement on the CGI-I (CST, ≥ 33% of participants reporting improvement), reduction in number of cataplexy episodes was 60.8% reduction (CST, ≥ 25% reduction), and reduction in ESS score was -6.5 (CST, ≥ 2-point decrease). At Weeks 3, 8 and 13, signifi...