Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial

作者：Hanrong Cheng, Liying Deng, Zili Meng, Wei Zhang, Tao Chen, Rui Chen, Shiyou Tang, Yunhui Lv, Xiaoli Su, Zhifen Liu, Xiaoqing Zhang, Xueyi Wang, Hongjing Mao, Nuofu Zhang, Huan Yu, Jiyang Pan, Yuping Xie, Jiyou Tang, Shankai Yin, Zan Wang, Maoqing Tong, Shuqin Zhan, Chunxue Wang, Bei Wang, Weihua Zhang, Weifeng Mi, Lin Lü · 发表于：CNS Drugs · 年份：2025 · DOI：10.1007/s40263-025-01232-1 · 被引用次数：4 · 研究领域：Obstructive Sleep Apnea Research、Sleep and related disorders、Sleep and Wakefulness Research

BACKGROUND AND OBJECTIVES: Excessive daytime sleepiness (EDS) is a prominent symptom of obstructive sleep apnea (OSA), negatively affecting patients' quality of life. The objective of this study was to assess the efficacy and safety of solriamfetol in patients with OSA with EDS from China. METHODS: This multicenter, randomized, double-blind, placebo-controlled phase 3 trial compared solriamfetol (75/150 mg once daily) with placebo for 12 weeks. Adults diagnosed with OSA, mean Maintenance of Wakefulness Test (MWT) sleep latency < 30 min, and Epworth Sleepiness Scale (ESS) score ≥ 10 were included. Patients with disorders causing EDS other than OSA were excluded. Co-primary endpoints were change from baseline to week 12 in MWT mean sleep latency and ESS score; a key secondary endpoint was improvement on Patient Global Impression of Change (PGI-C), assessed on a seven-point scale. MWT was performed at baseline and at weeks 2, 5, and 12, whereas the ESS and PGI-C were evaluated at weeks 2, 5, 8, and 12. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, 24-h ambulatory blood pressure monitoring, 12-lead electrocardiogram, and physical examination. Statistical analyses of co-primary endpoints were performed on the full analysis set (FAS) using a mixed model for repeated measures (MMRM). Safety analyses were performed on the safety population. A hierarchical testing sequence was used to control multiplicit...