Abstract Details

Title Assessment of the Effect of Lemborexant Versus Placebo and Zolpidem on the Duration of REM Sleep by Quarter-of-the-Night Intervals in Older Adults with Insomnia Disorder

Topic Sleep

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-001

Objective Examine acute effect of lemborexant (LEM) vs placebo and zolpidem tartrate extended-release 6.25mg on REM pressure, assessed by mean changes in REM latency (REM-L) and REM duration in 2-hour quarter-of-the-night (QoN) intervals.

Background In Study 304 (NCT02783729), LEM increased REM sleep in adults ≥55y with insomnia disorder.

Design/Methods Study 304 (n=1006) was 1mo, randomized, double-blind, placebo- and active-controlled (zolpidem). Subjects received placebo, zolpidem, or LEM (5mg [LEM5]; 10mg [LEM10]). Paired polysomnographic assessments were conducted at baseline, first (N1/2), and last (N29/30) 2 nights.

Results

Baseline REM-L was normal and similar across treatment groups (98.4-101.4min). On N1/2 and N29/30, mean(SD) REM-L significantly decreased with LEM5 (N1/2: −42.6[53.9]; N29/30: −30.7[55.7]) and LEM10 (N1/2: −49.6[52.9; N29/30: −37.7[56.2]) vs placebo (N1/2: −6.9[54.5]; N29/30: −7.7 [62.3]) and zolpidem (N1/2: 0.2[54.2]; N29/30: −4.0[56.4]) (all P<0.0001). Neither zolpidem vs placebo comparison was significant.

Baseline REM within each QoN was similar across groups. On N1/2, REM (range) across quarters was: 16.5-23.8 (LEM5); 19.7-26.1 (LEM10); 10.3-21.6 (placebo); and 8.5-22.8 (zolpidem). On N29/30, ranges were: 14.4-22.4 (LEM5); 16.9-24.1 (LEM10); 9.2-21.5 (placebo); and 8.3-22.3 (zolpidem).

On N1/2, REM significantly increased in each QoN with LEM10 compared with placebo (all P<0.0001) and zolpidem (all P<0.001). With LEM5, REM significantly increased vs placebo during Q1/Q3/Q4 (all P<0.05) and vs zolpidem during Q1/Q2 (both P<0.01). For zolpidem vs placebo, REM was significantly decreased during Q1 (P<0.05) and significantly increased during Q3 (P<0.05).

On N29/30, REM significantly increased with LEM10 vs placebo in each QoN (all P<0.05) and vs zolpidem in Q1/Q3/Q4 (all P<0.05). With LEM5, REM significantly increased vs placebo and zolpidem in Q1 (both P<0.0001). No significant differences were observed for zolpidem vs placebo on N29/30. Increases in REM were significantly greater on N1/2 than N29/30 with LEM5 (all P<0.05) and LEM10 (all P<0.0001).

Conclusions LEM, unlike zolpidem, acutely increases REM pressure.

Authors/Disclosures
Margaret Moline PRESENTER	Margaret Moline has received personal compensation for serving as an employee of EISAI, INC.. Margaret Moline has received intellectual property interests from a discovery or technology relating to health care. Margaret Moline has received personal compensation in the range of $0-$499 for serving as a review, loan repayment program with NIH.
Gary Zammit	Gary Zammit has received personal compensation for serving as an employee of Clinilabs, Inc.. Gary Zammit has received stock or an ownership interest from Clinilabs, Inc. Gary Zammit has received stock or an ownership interest from Sleep Disorders Institute. Gary Zammit has received stock or an ownership interest from Home Sleep and Respiratory Care.
Thomas Roth, PhD (Henry Ford Hospital)	Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Roth has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Avadel. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz.
Dinesh Kumar	Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
	No disclosure on file

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