{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T14:54:10Z","timestamp":1788792850092,"version":"build-2803163510"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,7,2]],"date-time":"2021-07-02T00:00:00Z","timestamp":1625184000000},"content-version":"vor","delay-in-days":123,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate effects of lemborexant (LEM), a dual orexin receptor antagonist, on next-morning sleep propensity assessed by a modified Multiple Sleep Latency Test (M-MSLT) in adults with insomnia disorder.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Study 107 (E2006-A001-107) was a phase 1, randomized, double-blind, four-period crossover study. Subjects (n = 69) received oral single-dose placebo, LEM 5 mg (LEM5), and LEM 10 mg (LEM10) at bedtime in periods 1\u20133 in a randomized crossover and open-label flurazepam 30 mg in period 4. After an 8-hour overnight sleep opportunity, the M-MSLT measured average sleep onset latency (SOL). Mean change from baseline in average SOL versus placebo of \u22126.0 min or more was considered clinically meaningful. Other sleep propensity assessments included the proportion of subjects with average SOL &amp;gt;6 min shorter than placebo. LEM plasma concentrations, safety, and tolerability were also assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>M-MSLT assay sensitivity was confirmed by a clinically meaningful decrease in average SOL with flurazepam versus placebo (least squares mean [LSM] difference \u20136.06 min; 1-sided p &amp;lt; 0.0001). In contrast, decreases in average SOL with LEM5 (LSM difference vs. placebo \u20131.15 min; 1-sided p = 0.0262) and LEM10 (\u20133.48 min; p &amp;lt; 0.0001) did not meet the predefined threshold for a clinically meaningful effect (LEM5, \u20132.12; LEM10, \u20134.46). Some individuals did experience higher sleep propensity (average SOL &amp;gt;6.0 min shorter than placebo), particularly with LEM10 (LEM10, 29.4%; LEM5, 13.2%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In contrast to flurazepam, LEM5 and LEM10 did not show clinically meaningful mean increases in next-morning sleep propensity versus placebo. The possibility that some subjects may experience residual morning effects cannot be excluded.<\/jats:p><jats:p>Clinical trial registration: ClinicalTrials.gov, NCT02350309<\/jats:p><\/jats:sec>","DOI":"10.1093\/sleepadvances\/zpab011","type":"journal-article","created":{"date-parts":[[2021,7,2]],"date-time":"2021-07-02T18:15:31Z","timestamp":1625249731000},"source":"Crossref","is-referenced-by-count":8,"title":["Assessment of morning sleep propensity with lemborexant in adults with insomnia disorder in a randomized, placebo-controlled crossover study"],"prefix":"10.1093","volume":"2","author":[{"given":"David","family":"Mayleben","sequence":"first","affiliation":[{"name":"Community Research , Cincinnati, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"Neurotrials Research, Inc. , Atlanta, GA , 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