Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea

作者：Clete A. Kushida, Gary Zammit, Jocelyn Y. Cheng, Dinesh Kumar, Margaret Moline · 发表于：Sleep Medicine · 年份：2024 · DOI：10.1016/j.sleep.2024.12.023 · 被引用次数：13 · 研究领域：Sleep and Wakefulness Research、Sleep and related disorders、Sleep and Work-Related Fatigue

OBJECTIVE/BACKGROUND: Comorbid insomnia with obstructive sleep apnea (COMISA) is associated with worse daytime function and more medical/psychiatric comorbidities vs either condition alone. COMISA may negatively impact sleep duration and reduce rapid eye movement (REM) sleep, thereby impairing cognition. These post-hoc analyses evaluated the effect of lemborexant (LEM), a dual-orexin-receptor antagonist approved for adults with insomnia, on sleep architecture in participants with COMISA. PATIENTS/METHODS: E2006-G000-304 was a phase 3, one-month polysomnography trial in adults aged ≥55 years with insomnia receiving LEM 5 mg (LEM5) or 10 mg (LEM10), placebo (PBO), or zolpidem-tartrate-extended-release 6.25 mg (ZOL). Sleep architecture was determined from 2 nights during placebo run-in (baseline), nights 1 and 2 (NT1/2), and nights 29 and 30 (NT29/30) of treatment. RESULTS: In the Full Analysis Set, 40.8 % (410/1006) had mild obstructive sleep apnea (OSA; apnea-hypopnea-index ≥5 and <15 events/hour of sleep). Mean change from baseline (CFB) in total sleep time (TST) was significantly greater at NT1/2 and NT29/30 with LEM5 and LEM10 vs ZOL (NT1/2, LEM5, P ≥ 0.05; LEM10, P < 0.0001; NT29/30, both P < 0.0001) and PBO (NT1/2 and NT29/30, all P < 0.0001). REM sleep and REM latency CFB were significantly greater (P < 0.0001 and P < 0.01, respectively) for LEM5 and LEM10 vs PBO/ZOL at NT1/2 and NT29/30. CONCLUSIONS: LEM significantly increased TST in participants with insomnia and mild...