The incidence of abnormal dreams and nightmares in adults with insomnia treated with lemborexant: results from two Phase 3 studies

Document Type

Conference Proceeding

Publication Date

12-1-2022

Publication Title

Int J Radiat Oncol Biol Phys

Keywords

lemborexant, placebo, zolpidem tartrate, adult, Australia, Canada, conference abstract, double blind procedure, dream, drug combination, drug safety, drug therapy, female, human, incidence, insomnia, Insomnia Severity Index, Japan, major clinical study, nightmare, phase 3 clinical trial, randomization, randomized controlled trial, REM sleep, United States

Abstract

Introduction: Abnormal dreams and nightmares have been reported by patients with insomnia both before and after treatment with hypnotics. Since dual orexin receptor antagonists (DORAs) such as lemborexant (LEM) increase REM sleep, during which dream content is more likely to be recalled, we assessed the frequency of reports of nightmares/abnormal dreams in subjects treated with LEM during two Phase 3 studies. LEM is approved in multiple countries including the United States, Japan, Canada and Australia for the treatment of adults with insomnia. Materials and Methods: Study 303 (SUNRISE-2; NCT02952820) was a 12 month, randomized, double-blind, placebo (PBO)-controlled (first 6 month [Period 1]), phase 3 study that enrolled subjects aged ≥18 years with insomnia disorder and Insomnia Severity Index (ISI) scores ≥15. During Period 1, the safety analysis set (SAS) included: PBO, n=319; LEM 5 mg, (LEM5), n=314; LEM 10 mg (LEM10), n=314. Study 304 (SUNRISE-1; NCT02783729) was a 1 month, randomized, double-blind, PBO- and active-controlled (zolpidem tartrate extended-release 6.25 mg [ZOL-ER]) study of LEM5 and LEM10. The SAS included: PBO, n=209; ZOL-ER, n=263; LEM5, n=266; LEM10, n=268. Results: In Study 303 Period 1, 28/947 subjects (3.0%) reported nightmares (n=12; PBO, n=1; LEM5, n=4; LEM10, n=7) or abnormal dreams (n=17; PBO, n=6; LEM5, n=7; LEM10, n=4) as treatment-emergent adverse events (TEAEs). In Study 304, 12/1006 subjects (1.2%) reported nightmares (n=4; PBO, n=1; ZOL-ER, n=0; LEM5; n=2; LEM10, n=1) or abnormal dreams (n=8; PBO, n=1; ZOL-ER, n=3; LEM5, n=0; LEM10, n=4). 32/40 subjects (80.0%) reporting these events were female. In the LEM groups, 11/28 subjects (39.3%) reported the TEAE within 3 days of treatment initiation. There were 2 TEAEs of nightmare/abnormal dreams during the PBO run-in prior to randomization. Conclusions: Abnormal dreams/nightmares were not common events in either study. Incidence was slightly higher with LEM10 and higher in females, which was consistent with a greater proportion of females being enrolled in both studies. Acknowledgements: Supported by Eisai Inc.

Volume

114

Issue

5

First Page

1058

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