P.047 Effect of lemborexant on sleep architecture in subjects with comorbid insomnia and mild obstructive sleep apnea from a phase 3 trial

Background: Lemborexant (LEM), a dual-orexin-receptor-antagonist approved to treat adults with insomnia, increases total sleep time (TST) and rapid eye movement (REM) sleep. Patients obstructive apnea (OSA) or co-morbid insomnia OSA (COMISA) report sleeping difficulties reduced REM, therefore architecture was analyzed during LEM treatment. Methods: Study E2006-G000-304 (NCT02783729) 1-month, randomized, double-blind, placebo (PBO)- active-comparator zolpidem-ER 6.25mg (ZOL)-controlled study in ≥55y disorder. Subjects received PBO, 5mg (LEM5), 10mg (LEM10), ZOL. Least-square-mean duration of each stage (minutes) compared from pooled data on Nights (NT)1/2 NT29/30 for mild subjects (apnea hypopnea index ≥5 <15 events/h). Treatment-emergent adverse events (TEAEs) were recorded. Results: Of 409 (LEM5=114/LEM10=105/ZOL=112/PBO=78) change baseline (CFB) TST REM significantly larger both doses versus ZOL/PBO nights. CFB nonREM higher (P<0.0001) PBO LEM5 showed (P<0.05) ZOL at NT29/30. Most TEAEs mild/moderate. Conclusions: increased TST, OSA. Data support treatment the COMISA population.