Poster Presentation Australian and New Zealand Society for Geriatric Medicine Annual Scientific Meeting 2025

Impact of Lemborexant on Daytime Sleepiness/Alertness in Participants With Comorbid Insomnia and Mild Obstructive Sleep Apnea (117054)

Margaret Moline 1 , Fiona Gardiner 2 , Dinesh Kumar 1 , Jocelyn Y. Cheng 1 , Michelle van Rensburg 3 , Mark I. Boulos 4 5 6
  1. Eisai Inc., Nutley, NJ, United States
  2. Eisai Australia Pty Ltd, Melbourne, Victoria, Australia
  3. Eisai New Zealand Ltd, Auckland, New Zealand
  4. Department of Medicine, Division of Neurology, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Canada
  5. Hurvitz Brain Sciences Research Program, Sunnybrook Health Sciences Centre, Toronto, Canada
  6. Sleep Laboratory, Sunnybrook Health Sciences Centre, Toronto, Canada

Aims: COMISA (comorbid insomnia and obstructive sleep apnea) is associated with daytime functioning and cognitive impairments. Some sleep-promoting medications may exacerbate daytime impairment. 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 COMISA.

Methods: Of the overall population (n=1006), 410 (40.8%) adults (≥55 years of age) with comorbid insomnia disorder (Diagnostic and Statistical Manual, 5th edition; 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: A greater percentage of participants with COMISA experienced improvements in morning sleepiness across the treatment period with LEM versus PBO. Consistent with previous findings, LEM does not affect tasks requiring morning alertness.