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

Q: What was the primary purpose of the study?

To assess the efficacy and safety of solriamfetol in patients with OSA associated with excessive daytime sleepiness.

Q: How was the trial designed and what was the comparison?

A multicenter, randomized, double-blind, placebo-controlled phase 3 design compared solriamfetol 75/150 mg once daily with placebo for 12 weeks.

Q: What were the key efficacy outcomes at week 12?

Co-primary endpoints were met, showing increased MWT mean sleep latency and decreased ESS score for solriamfetol versus placebo at week 12, with improvement on PGI-C as a key secondary endpoint.

Sep 29, 2026

Upload by Guten tag

Excessive daytime sleepiness (EDS) is a key symptom of obstructive sleep apnea (OSA) that impairs patients’ daily functioning, cognition, and quality of life. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of solriamfetol in Chinese adults with OSA and EDS. Solriamfetol (75/150 mg once daily) was compared with placebo over 12 weeks. Co-primary outcomes were MWT sleep latency and ESS score change, with PGI-C as a key secondary endpoint, alongside comprehensive safety assessments.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages16

Reading Time40 min

AccessFree to download

Abstract

Background and Objectives

Methods

Results

Conclusions

Introduction

CNS Drugs (2026) 40:83–98 [https://doi.org/10.1007/s40263-025-01232-1](https://doi.org/10.1007/s40263-025-01232-1) 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 Hanrong Cheng1 · Liying Deng2 · Zili Meng3 · Wei Zhang4 · Tao Chen5 · Rui Chen6 · Shiyou Tang7 · Yunhui Lv8 · Xiaoli Su9 · Zhifen Liu10 · Xiaoqing Zhang11 · Xueyi Wang12 · Hongjing Mao13 · Nuofu Zhang14 · HuanYu15 · Jiyang Pan16 · Yuping Xie17 · Jiyou Tang18 · Shankai Yin19 · Zan Wang20 · Maoqing Tong21 · Shuqin Zhan22 · Chunxue Wang23 · Bei Wang24 · Weihua Zhang25 · Weifeng Mi25 · Lin Lu25 Received: 3 April 2025 / Accepted: 10 September 2025 / Published online: 23 October 2025 © The Author(s) 2025 Abstract 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 solriamfetolin 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 aseven-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. Results 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. Conclusions Solriamfetol demonstrated substantial efficacy and acceptable safety in Chinese patients with OSA with EDS, reinforcing its role as a viable treatment option. Trial Registration [ClinicalTrials.gov: NCT06103825](ClinicalTrials.gov: NCT06103825) . Extended author information avaliable on the last page of the article. 1 Introduction Obstructive sleep apnea (OSA) is the most common sleeprelated breathing disorder associated with significant health consequences [1] . Owing to its rising prevalence, it has posed a health and economic concern worldwide, particularly in China [2] . According to the scoring criteria of the America

FAQs

What was the primary purpose of the study?

To assess the efficacy and safety of solriamfetol in patients with OSA associated with excessive daytime sleepiness.

How was the trial designed and what was the comparison?

A multicenter, randomized, double-blind, placebo-controlled phase 3 design compared solriamfetol 75/150 mg once daily with placebo for 12 weeks.

What were the key efficacy outcomes at week 12?

Co-primary endpoints were met, showing increased MWT mean sleep latency and decreased ESS score for solriamfetol versus placebo at week 12, with improvement on PGI-C as a key secondary endpoint.

Sep 29, 2026

Upload by Guten tag