Post Hoc Analysis of Solriamfetol Efficacy in Obstructive Sleep Apnea Patients with Excessive Daytime Sleepiness Stratified by Disease Severity
Abstract
Introduction: Solriamfetol, a dopamine and norepinephrine reuptake inhibitor, is indicated for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA). This study aims to evaluate the efficacy and safety profiles of solriamfetol across different severity levels of OSA via the post hoc analysis of a randomized clinical trial in a Chinese population.
Methods: Participants were assigned in a 1:1 ratio to either the placebo group or solriamfetol group (dose titrated up to 150 mg/day) for 12 consecutive weeks, with randomization stratified by adherence status to primary OSA therapy. The co-primary endpoints were defined as the changes of mean sleep latency measured by the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) scores from baseline to week 12 in the full analysis set. The efficacy and safety profiles of solriamfetol were analyzed across subgroups stratified by baseline apnea hypopnea index (AHI).
Results: Among eligible patients for subgroup analysis, 42.5%, 34.5%, and 23% had baseline AHI 10% incidence in any treatment group) including upper respiratory tract infection, hyperuricemia, dizziness, and hypertension.
Conclusion: Solriamfetol showed good efficacy and tolerability regardless of OSA severity among Chinese OSA participants with EDS.
Trial registration: The parent study was registered at www.chinadrugtrials.org.cn with the trial number CTR20231397 on May 15, 2023.
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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