Core Viewpoint - The Phase III clinical trial results of Fazamorexant, an innovative anti-insomnia drug developed by Yangtze River Pharmaceutical Group, were unveiled at the World Sleep Congress 2025, marking a significant milestone in the global development of treatments for sleep disorders [1][2]. Group 1: Clinical Trial Details - The Phase III clinical trial was a multi-center, randomized, double-blind, and placebo-controlled study involving 1,034 adult patients with insomnia, aimed at evaluating the efficacy and safety of Fazamorexant [5]. - Fazamorexant, as a dual orexin receptor antagonist (DORA), demonstrated rapid efficacy and a favorable safety profile in adult patients with insomnia [5][6]. Group 2: Performance Indicators - Fazamorexant showed exceptional performance in key sleep indicators, including improved sleep efficiency, shortened time to fall asleep, and decreased nighttime awakenings, significantly outperforming publicly available clinical data of other DORAs [6]. - The drug exhibited a favorable safety and tolerability profile, with no observed rebound insomnia or withdrawal symptoms after discontinuation [6]. Group 3: Expert Recognition and Future Prospects - The drug's fast-acting and short-half-life characteristics were highlighted, suggesting it meets the treatment needs of patients with difficulty falling asleep while maintaining daytime activities [8]. - Following the conference, interest in Fazamorexant was expressed by Professor Emmanuel Mignot from Stanford University, indicating potential for further collaboration in trials [9]. - Yangtze River Pharmaceutical has submitted a new drug application (NDA) for Fazamorexant to the National Medical Products Administration (NMPA), aiming for accelerated review and registration to provide innovative treatment options for insomnia patients globally [11].