Abstract Details

Title Responder Profiles Over 12 Months for Sleep Onset and Sleep Maintenance Outcomes with Lemborexant

Topic Sleep

Presentation(s) Sleep Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 009

Background

In addition to evaluating response to treatment via comparing change from baseline (CFB) between active treatment and placebo (PBO), it is informative to assess the proportion of subjects with a specified size of response. This can help determine the expected level of improvement and characterize treatment success.

Objective

Assess sleep onset and sleep maintenance responses with lemborexant (LEM) over 12mo using cumulative responder analyses.

Design/Methods Study 303 (SUNRISE-2) was a randomized, double-blind, global phase 3 study of LEM. Subjects aged ≥18y with insomnia disorder were randomized to LEM (5mg [LEM5]; 10mg [LEM10]) or PBO for 6mo (Period-1). For the second 6mo (Period-2), LEM subjects continued their assigned dose and PBO subjects were rerandomized to LEM (reported separately). The cumulative proportion of subjects with CFBs (10-minute increments) in subjective sleep onset latency (sSOL) and subjective wake after sleep onset (sWASO) were plotted to generate the sleep onset and sleep maintenance responder profiles, respectively. Proportions were based on number of subjects with data at baseline (denominator) and at time of study visit; subjects who discontinued were counted as nonresponders.

Results

Sleep measure values were similar at baseline (median sSOL [min]: PBO, 55.9; LEM5, 53.6; LEM10, 55.7; mean[SD] sWASO [min]: PBO, 132.5[80.2]; LEM5, 132.8[82.5]; LEM10, 136.8[87.4]). More subjects had a CFB of ≥20min in sSOL with LEM compared with PBO (PBO, 30.4%; LEM5, 45.5%; LEM10, 44.9%) at 6mo; similar percentages were seen with LEM5 (40.4%) and LEM10 (43.3%) at 12mo. Also, at 6mo, more subjects had a CFB in sWASO of ≥60min with LEM compared with PBO (PBO, 24.2%; LEM5, 27.8%: LEM10, 30.2%); similar percentages were seen with LEM5 (27.8%) and LEM10 (27.7%) at 12mo. Most treatment-emergent adverse events were mild/moderate in severity.

Conclusions

Over the long term, treatment with LEM provided important persistent efficacy levels and was well tolerated.

Authors/Disclosures
Gary Zammit PRESENTER	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.
	No disclosure on file
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.
	No disclosure on file
Margaret Moline	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.