Efficacy and safety of vornorexant in Japanese patients with insomnia: a randomized, placebo-controlled phase 3 pivotal study

ClinicalTrials.gov ID: NCT05453136. Japan Registry of Clinical Trials ID: jRCT2031220209. A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder. https://clinicaltrials.gov/study/NCT05453136. https://jrct.mhlw.go.jp/en-latest-detail/jRCT2031220209. Statement of Significance Sleep disturbances lead to physical and mental health issues. Some pharmacotherapies for individuals with insomnia are available, but most of these have concerns including withdrawal, dependence, and next-day residual effects. Therefore, alternative treatment with minimal impact on these issues is highly desirable. This phase 3 study was conducted to confirm the efficacy and safety of vornorexant, a novel dual orexin antagonist having pharmacokinetic characteristics of rapid absorption and elimination, in patients with insomnia. Consequently, both tested doses showed superior efficacy compared to placebo, with significant reductions in subjective sleep latency and increases in sleep efficiency. These findings position vornorexant as a new treatment option for insomnia, offering improvements in sleep while avoiding the concerns associated with traditional hypnotics.