Neurology. 2025 Apr 8;104(7_Supplement_1):1947. doi: 10.1212/WNL.0000000000208838. Epub 2025 Apr 7.
ABSTRACT
OBJECTIVE: This post hoc analysis assessed the impact of lemborexant (LEM), a dual orexin-receptor antagonist approved to treat insomnia in adults, on morning sleepiness/alertness in participants with comorbid insomnia and mild obstructive sleep apnea (COMISA).
BACKGROUND: COMISA is associated with daytime functioning and cognitive impairments. Some sleep-promoting medications cause residual morning sleepiness, potentially exacerbating daytime impairment. Therefore, it was important to understand whether objective polysomnographic improvement of insomnia in COMISA participants treated with LEM was associated with an impact on morning sleepiness.
DESIGN/METHODS: Of the overall population (n=1006), data from a subgroup (n=410; 40.8%) of adults (≥55 years of age) with comorbid insomnia (Diagnostic and Statistical Manual, 5th edition, diagnosis of insomnia disorder; Insomnia Severity Index score ≥13) and mild obstructive sleep apnea (apnea-hypopnea-index, 5 to ≤15 events/h) from Study E2006-G000-304 (NCT02783729), a 1-month, randomized, placebo- and active-controlled study, were analyzed. Participants received placebo (PBO), LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate 6.25mg (not reported). A daily sleep diary assessed morning sleepiness/alertness rated from 1 (extremely sleepy) to 9 (extremely alert). The percentage of participants shifting from baseline mild/moderate sleepiness (≤3) towards greater alertness (4, 5, or >5) during the first and last 7 mornings of the study was analyzed.
RESULTS: At baseline, 17/75 (22.7%), 36/112 (32.1%), and 28/104 (26.9%) participants with COMISA receiving PBO, LEM5, or LEM10, respectively, reported mild/moderate sleepiness. Of these participants, across the first and last 7 mornings, a greater percentage shifted from mild/moderate sleepiness towards alertness with LEM5 (66.7%, 82.9%) and LEM10 (64.3%, 75.0%) versus PBO (47.1%, 64.7%), respectively.
CONCLUSIONS: While the sample size was too small to detect statistical differences, a greater percentage of participants with COMISA experienced improvements in morning sleepiness across the treatment period with LEM versus PBO. These data align with previous findings that LEM does not affect tasks requiring morning alertness. Disclosure: 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. Ms. Gardiner has received personal compensation for serving as an employee of Eisai Australia Pty Ltd. Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc. Dr. Cheng has received personal compensation for serving as an employee of Eisai Inc. Dr. Boulos has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Precision AQ. Dr. Boulos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals. Dr. Boulos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Paladin Labs. Dr. Boulos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai. Dr. Boulos has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sleep Medicine (jpurnal). The institution of Dr. Boulos has received research support from Canadian Institutes of Health Research. The institution of Dr. Boulos has received research support from Slamen-Fast New Initiatives in Neurology Award. The institution of Dr. Boulos has received research support from Green Mountain . The institution of Dr. Boulos has received research support from RLS Foundation. The institution of Dr. Boulos has received research support from Temerty Centre for AI Research and Education in Medicine (T-CAIREM). The institution of Dr. Boulos has received research support from Heart & Stroke Foundation of Canada. The institution of Dr. Boulos has received research support from Alternative Funding Plan from the Academic Health Sciences Centres of Ontario. The institution of Dr. Boulos has received research support from StrokeCog. The institution of Dr. Boulos has received research support from McLaughlin Centre for Molecular Medicine . Dr. Boulos has received personal compensation in the range of $5,000-$9,999 for serving as a speaker with Jazz Pharmaceuticals. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.
PMID:40194125 | DOI:10.1212/WNL.0000000000208838
