Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder

Abstract

StudyObjectives: Changes to sleep architecture that occur as a result of the normal aging processmay also exacerbate insomnia in older individuals. Therefore, this study assessed the impact of lemborexant compared with placebo and zolpidem tartrate extended release on objective sleep architecture parameters, as measured by polysomnography, in older adults (ages ≥ 55 years) with insomnia disorder from a phase 3 study. Methods: Study E2006-G000-304 (SUNRISE 1; NCT02783729) was a global, multicenter, randomized, double-blind, placebo-controlled, active comparator (zolpidem)-controlled, parallel-group study comparing 2 dose levels of lemborexant (5 mg and 10 mg). Sleep architecture was measured using polysomnography. Assessmentswere collected at baseline during a single-blind placebo run-in and during the first 2 nights and last 2 nights of treatment. Mean values for each sleep stage were based on the 2 consecutive polysomnograms. Results: Treatment with lemborexant resulted in significantly greater increases from baseline in total sleep time compared with both placebo and zolpidem. Significant increases frombaseline in rapid eyemovement sleep and significant decreases frombaseline in latency to rapid eyemovement sleepwere also observed with lemborexant compared with placebo and zolpidem. Conclusions: These findings suggest that treatment with lemborexant may address some of the alterations in sleep architecture normally observed in older individuals with insomnia.