Impact of Lemborexant on Daytime Sleepiness/Alertness in Participants With Comorbid Insomnia and Mild Obstructive Sleep Apnea
Margaret Moline1, Fiona Gardiner2, Dinesh Kumar1, Jocelyn Y. Cheng1, Mark I. Boulos3
1Eisai Inc., 2Eisai Australia Pty Ltd, 3Sleep Laboratory, Sunnybrook Health Sciences Centre
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.
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