Effect of lemborexant on insomnia severity, morning alertness, and cognition in participants with insomnia disorder and mild obstructive sleep apnea.

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.