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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

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Pubmed体系：
作者：
Cheng Hanrong[1] * ; Deng Liying[2] ; Meng Zili[3] ; Zhang Wei[4] ; Chen Tao[5] ; Chen Rui[6] ; Tang Shiyou[7] ; Lv Yunhui[8] ; Su Xiaoli[9] ; Liu Zhifen[10] ; Zhang Xiaoqing[11] ; Wang Xueyi[12] ; Mao Hongjing[13] ; Zhang Nuofu[14] ; Yu Huan[15] ; Pan Jiyang[16] ; Xie Yuping[17] ; Tang Jiyou[18] ; Yin Shankai[19] ; Wang Zan[20] ; Tong Maoqing[21] ; Zhan Shuqin[22] ; Wang Chunxue[23] ; Wang Bei[24] ; Zhang Weihua[25] ; Mi Weifeng[26] ; Lu Lin[25] ;
机构： [1]Department of Sleep Medicine, Institute of Respiratory Diseases, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, Guangdong, China. [2]Department of Neurology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China. [3]Department of Respiratory and Critical Care Medicine, The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University, Huaian, Jiangsu, China. [4]Department of Neurology, Yan'an University Xianyang Hospital, Xianyang, China. [5]The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [6]Sleep Center, The Second Affiliated Hospital of Soochow University, Suzhou, China. [7]Chongqing University, Three Gorges Hospital, Chongqing, China. [8]Department of Sleep Medicine, The First People's Hospital of Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, China. [9]Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China. [10]Department of Psychiatry, First Hospital of Shanxi Medical University, Taiyuan, China. [11]Department of ENT and Sleep Medicine Center, West China School of Public Health, West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China. [12]The First Hospital of Hebei Medical University, Mental Health Institute of Hebei Province, Shijiazhuang, China. [13]Psychosomatic Medicine Department, Department of Sleep Medicine, Hangzhou Seventh People's Hospital, Hangzhou, China. [14]The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [15]Sleep and Wake Disorders Center, Department of Neurology, Huashan Hospital, Fudan University, National Center for Neurological Disorders and National Clinical Research Center for Aging and Medicine, Shanghai, China. [16]Sleep Medicine Center, The First Affiliated Hospital of Jinan University, Guangzhou, China. [17]Gansu Provincial Hospital, Lanzhou, China. [18]Shandong Provincial Qianfoshan Hospital, Jinan, China. [19]Department of Otolaryngology, Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China. [20]Department of Neurology, The First Hospital of Jilin University, Changchun, China. [21]Department of Psychosomatic Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, China. [22]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [23]Department of Neuropsychiatry and Behavioral Neurology and Clinical Psychology, Sleep Center, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China. [24]Shanxi Provincial Sleep Disorder Clinical Center, Second Hospital of Shanxi Medical University, Taiyuan, China. [25]Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China. [26]Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China. weifengmi@bjmu.edu.cn.
出处：
DOI： 10.1007/s40263-025-01232-1
ISSN：

摘要：
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.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 multiplicity.Of the 204 patients randomized (1:1) into placebo and solriamfetol groups, 192 completed the study (96 in each group). Co-primary endpoints were met, with significantly increased mean MWT sleep latency (P < 0.0001) and decreased ESS score (P = 0.0017) in the solriamfetol group (MWT, n = 95; ESS, n = 97) versus placebo (MWT, n = 95; ESS, n = 96) at week 12. Higher proportion of participants receiving solriamfetol (n = 90; 89.1%) reported improvement in PGI-C versus placebo (n = 77; 77.0%; P = 0.0221). At least one TEAE was reported in solriamfetol (n = 84; 82.4%) and placebo (n = 67; 65.7%) groups. The occurrence of serious TEAEs was low, with one incidence in both groups. Most frequently reported TEAEs in solriamfetol group included upper respiratory tract infection, dizziness, hyperuricemia, hypertension, hyperlipidemia, hypertriglyceridemia, and increased blood creatine phosphokinase. Most TEAEs were of mild/moderate severity and did not lead to study treatment discontinuation.Solriamfetol demonstrated substantial efficacy and acceptable safety in Chinese patients with OSA with EDS, reinforcing its role as a viable treatment option.ClinicalTrials.gov: NCT06103825.© 2025. The Author(s).

基金：
The study and the open access fee was funded by Ignis Therapeutics (Suzhou) Limited, China
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 临床神经病学 1 区 药学 1 区 精神病学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 临床神经病学 1 区 药学 1 区 精神病学
第一作者：
第一作者机构： [1]Department of Sleep Medicine, Institute of Respiratory Diseases, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, Guangdong, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Cheng Hanrong,Deng Liying,Meng Zili,et al.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[J].CNS Drugs.2025,doi:10.1007/s40263-025-01232-1.
APA：
Cheng Hanrong,Deng Liying,Meng Zili,Zhang Wei,Chen Tao...&Lu Lin.(2025).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.CNS Drugs,,
MLA：
Cheng Hanrong,et al."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".CNS Drugs .(2025)

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