Assessment of patient-reported outcomes for sleep status and daytime functioning with vornorexant administration: results from a randomized phase 3 pivotal study

Abstract

To investigate the effects of vornorexant, a novel dual orexin receptor antagonist developed for the treatment of insomnia, on patient-reported sleep status and daytime functioning in a randomized, double-blinded, placebo-controlled pivotal phase 3 trial. A total of 589 patients were administered placebo, vornorexant 5 mg, or vornorexant 10 mg in a 1:1:1 ratio for 2 weeks. The patients completed the Insomnia Severity Index (ISI), Sheehan Disability Scale (SDS), and Leeds Sleep Evaluation Questionnaire (LSEQ) as secondary endpoints. Both vornorexant 5 mg and 10 mg significantly improved total and daytime functioning scores of the ISI, SDS, and subsets of getting to sleep, quality of sleep, and behavior following wakefulness of LSEQ, compared with the placebo. However, the subsets of awakening from sleep did not demonstrate significant differences between the groups. Vornorexant was well tolerated throughout the study. These results support the beneficial effects of vornorexant on subjective sleep status and daytime functioning as assessed by using standardized subjective assessment tools in patients with insomnia, and suggest its broad clinical relevance as a therapeutic option to treat insomnia.