0481 Impact of Lemborexant on Fatigue Severity in Subjects with Clinically Significant Levels of Fatigue at Baseline. (27th May 2020)

• Record Type: Journal Article
• Authors: Rosenberg, R; Kumar, D; Pinner, K; Perdomo, C; Moline, M
• Is Part Of: Sleep. Volume 43(2020)Supplement 1
• Page Start: A184
• Page End: A185
• Publication Date: 2020-05-27
• Subjects: Sleep -- Physiological aspects -- Periodicals; Sleep disorders -- Periodicals; Sommeil -- Aspect physiologique -- Périodiques; Sommeil, Troubles du -- Périodiques; Sleep disorders; Sleep -- Physiological aspects; Sleep -- physiological aspects; Sleep Wake Disorders; Psychophysiology; Electronic journals; Periodicals; 616.8498
• DOI: 10.1093/sleep/zsaa056.478
• Languages: English
• ISSNs: 0161-8105

Abstract

Abstract: Introduction: In Phase 3 SUNRISE-1 (NCT02783729; E2006-G000-304) and SUNRISE-2 (NCT02952820; E2006-G000-303), lemborexant (LEM) provided significant benefit versus placebo on sleep diary-based sleep onset/maintenance outcomes over 1mo and 6mo, respectively, in subjects with insomnia disorder. The impact of LEM on patient-reported fatigue, assessed using the Fatigue Severity Scale (FSS), in subjects with clinically significant fatigue (CSF) at baseline was examined for each study. Methods: SUNRISE-1 was a 1mo, randomized, double-blind, placebo- and active-controlled, parallel-group study in female (≥55y) and male (≥65y) subjects (n=1006); subjects received placebo, LEM 5mg (LEM5), LEM 10mg (LEM10) or zolpidem tartrate extended-release (not reported here). SUNRISE-2 was a 12mo, randomized, double-blind study in subjects age ≥18y (n=949). Subjects received placebo, LEM5, or LEM10 for 6mo. Placebo subjects were rerandomized to LEM5 or LEM10 for another 6mo; LEM subjects continued assigned treatment. CSF was defined as FSS total score (FSSts) ≥36. Results: In subjects with baseline CSF, in SUNRISE-1, baseline FSSts was 46.8, 46.5, and 46.6 in placebo (n=117), LEM5 (n=157), and LEM10 (n=153) groups, respectively, and, in SUNRISE-2, was 45.7, 46.4, and 45.8 in placebo (n=169), LEM5 (n=181), and LEM10 (n=173) groups, respectively. At 1mo, mean changes from baseline in FSSts were not significantly different vs placebo for LEM5 in both studies, and for LEM10 in SUNRISE-1. In SUNRISE-2, LEM10 significantly decreased mean [SD] FSSts from baseline vs placebo at 1mo (LEM10, −11.2[13.9] vs placebo, −8.7[10.5]; P =0.03). By 6mo in SUNRISE-2, both LEM5 and LEM10 significantly decreased mean [SD] FSSts from baseline versus placebo (LEM5, −15.4[13.8]; LEM10, −15.0[14.2] vs placebo, −11.2[11.6]; both P <0.05). At 12mo, mean [SD] FSSts improvements were sustained for LEM5 (−20.4[12.8]) and LEM10 (−18.1[14.7]). Conclusion: In subjects with CSF, longer treatments (>1mo) may be needed to observe significant FSSts improvements, which were evident at 6mo and sustained at 12mo with continuous LEM treatment. Support: Eisai Inc.