biostudies-literatureUnknown4Dash AEisai Incorporated<h4>Study objectives</h4>Lemborexant (LEM) is a dual orexin receptor antagonist approved for treating adults with insomnia. We analyzed the efficacy (subjective sleep outcomes) and safety of LEM over 12 months in the subgroup of Asian subjects from Study E2006-G000-303 (Study 303).<h4>Methods</h4>Study 303 was a 12-month, randomized, placebo-controlled (first 6 months), double-blind, parallel-group, phase 3 study of adults with insomnia disorder. During the 6-month Period 1, subjects were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10); LEM subjects continued treatment in the following 6-month Period 2. Outcome measures included subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), InsSleep medicine: X100044https://www.ebi.ac.uk/biostudies/studies/S-EPMC8987601biostudies-literatureEfficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder.PMC8987601Hayashida KYun CHLan THDash AMoline MYardley JLim SCKubota NInoue YHuang CLPinner KfalseEfficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder.<h4>Study objectives</h4>Lemborexant (LEM) is a dual orexin receptor antagonist approved for treating adults with insomnia. We analyzed the efficacy (subjective sleep outcomes) and safety of LEM over 12 months in the subgroup of Asian subjects from Study E2006-G000-303 (Study 303).<h4>Methods</h4>Study 303 was a 12-month, randomized, placebo-controlled (first 6 months), double-blind, parallel-group, phase 3 study of adults with insomnia disorder. During the 6-month Period 1, subjects were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10); LEM subjects continued treatment in the following 6-month Period 2. Outcome measures included subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Ins2022-01-01T00:00:00Z2022 Dec2026-05-31T01:05:40.063Z2025-04-04T11:31:49.579ZS-EPMC89876013540289410.1016/j.sleepx.2022.100044