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Poster
1579068
Impact of Lemborexant on Daytime Sleepiness/Alertness in Subjects With Insomnia Disorder and Baseline Sleepiness
Psych Congress 2023
This work was sponsored by Eisai Inc.
Introduction:
Some sleep-promoting drugs may cause residual morning sleepiness due to sedative side effects. This post-hoc analysis of Study 304 (NCT02783729) assessed the impact of lemborexant (LEM), a competitive dual orexin receptor antagonist approved for the treatment of adults with insomnia, on morning sleepiness/alertness in subjects with baseline mild/moderate morning sleepiness.
Methods:
Study 304 was a 1-month, randomized controlled study in adults age ≥55 years with insomnia disorder (Nf1006). Subjects received placebo (PBO), LEM 5mg (LEM5) or 10mg (LEM10), or zolpidem tartrate 6.25mg (not reported). A daily sleep diary assessed morning sleepiness, which was rated from 1 (extremely sleepy) to 9 (extremely alert). Parameters analyzed included change from baseline sleepiness and proportion of subjects shifting from baseline mild/moderate sleepiness (≤3) towards alertness (4, 5, or >5).
Results:
At baseline, 206 subjects reported mild/moderate sleepiness (PBO, n=60; LEM5, n=68; LEM10, n=78). Alertness ratings increased significantly in the first 7 mornings with LEM5 and LEM10 (respective least squares mean treatment difference: 0.67 and 0.51; both P
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