P.054 Older subjects with insomnia disorder and comorbid pain at baseline: response to Lemborexant

Background: There is a well-established reciprocal relationship between pain and poor sleep. Therefore, we evaluated whether an approved sleep-promoting drug, lemborexant (LEM), could improve sleep in older adults who reported both insomnia pain. Methods: Study E2006-G000-304 (NCT02783729) was 1-month, placebo (PBO)- active-controlled study subjects (age ≥55y) with disorder. Those reporting some/severe on the pain/discomfort dimension of EQ-5D-3L at baseline were included. Subjects randomized to (PBO), LEM 5mg (LEM5), 10mg (LEM10) or zolpidem (not here). Changes from (CFB) objective parameters latency-to-persistent (LPS) total-sleep-time (TST) analyzed paired polysomnograms. Results: 183/743 (24.6%) PBO (n=55/208[26.4%]), LEM5 (n=78/266[29.3%]) LEM10 (n=50/269[18.6%]) treatment groups some/extreme baseline, median LPS (minutes): 31.0, 29.4, 42.1, respectively. Respective CFB for beginning (Nights[NT]1/2: +2.5, –8.4, –15.8; P<0.005) significantly larger/decreased LEM5/LEM10 versus end (NT29/30: –7.1, –9.9, –9.0; P=0.031). Mean TST (minutes) 335.3 336.3 324.3 (LEM10), mean larger/increased (P<0.001) NT1/2 NT29/30. Conclusions: Results suggest may effectively treat comorbid Support: Eisai Inc.