ArticleSleep medicine: X2026
Effect of lemborexant on insomnia severity, morning alertness, and cognition in participants with insomnia disorder and mild obstructive sleep apnea.
Article in Sleep medicine: X, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02783729 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
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6 authors.
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Abstract
Objective: To examine the effect of lemborexant (LEM) on insomnia severity, morning alertness, and cognition in participants with COMISA (comorbid insomnia and obstructive sleep apnea [OSA]). Methods: This post hoc analysis of study E2006-G000-304 (NCT02783729), a phase 3, randomized, double-blind, 1-month, parallel-group study of LEM 5 mg (LEM5), LEM 10 mg (LEM10), zolpidem tartrate extended-release 6.25 mg (ZOL), and placebo (PBO) included participants with insomnia and mild OSA (≥5 to <15 events/h sleep). Disease severity (assessed via Insomnia Severity Index [ISI]), cognition, and morning alertness were examined. Results: This analysis included 410 participants (LEM5, n = 114; LEM10, n = 105; ZOL, n = 113; PBO, n = 78) with COMISA. Mean (SD) changes from baseline in ISI total scores were lower (improved) with LEM5 (-7.1 [5.3]), LEM10 (-7.7 [5.6]), and ZOL (-8.7 [6.7]) versus PBO (-5.7 [5.9]) at Day 31, with LEM10 and ZOL reaching statistical significance (LEM5 vs PBO: P = 0.1100; LEM10 vs PBO: P = 0.0278; ZOL vs PBO: P = 0.0011). LEM did not significantly impact next-morning cognitive functioning and alertness. ZOL negatively impacted power of attention and quality of memory cognitive domains at Days 2/3 and speed of memory retrieval at Days 30/31 versus PBO. Conclusion: LEM reduced insomnia severity without significantly impacting next-morning cognitive functioning and alertness in patients with mild untreated OSA.
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