{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T16:05:08Z","timestamp":1775318708040,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,9,12]],"date-time":"2024-09-12T00:00:00Z","timestamp":1726099200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Sleep Research"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Because some hypnotics worsen respiratory conditions, it was important to determine the respiratory safety of lemborexant, a competitive dual orexin\u2010receptor antagonist approved to treat adults with insomnia, in subjects with moderate\u2010to\u2010severe chronic obstructive pulmonary disease. E2006\u2010A001\u2010113 (Study 113; NCT04647383) was a multicentre, multiple\u2010dose, randomised, double\u2010blind, placebo\u2010controlled, two\u2010period crossover study in adult subjects with moderate or severe chronic obstructive pulmonary disease (per spirometry\u2010based Global Initiative for Chronic Obstructive Lung Disease [GOLD] criteria). Subjects (<jats:italic>N<\/jats:italic>\u2009=\u200930) were randomised to two treatment sequences comprising 8\u2010night treatment periods (washout \u2265\u200914\u2009days) with lemborexant 10\u2009mg or placebo. Peripheral oxygen saturation (SpO<jats:sub>2<\/jats:sub>; primary endpoint), apnea\u2013hypopnea index, objective sleep parameters and sleep architecture measures were assessed after single (Day 1) and multiple (Day 8) doses. There was no significant difference in least\u2010squares mean SpO<jats:sub>2<\/jats:sub> after a single dose of lemborexant (91.1%) versus placebo (91.5%). Although a statistically significant difference in SpO<jats:sub>2<\/jats:sub> was observed after multiple doses (least\u2010squares mean: lemborexant, 91.3%; placebo, 90.8%) favouring lemborexant, this was not considered clinically meaningful. Apnea\u2013hypopnea index was not significantly different between treatments after single or multiple doses. Total sleep time and total rapid eye movement sleep were significantly greater on Days 1 and 8 with lemborexant versus placebo. Treatment\u2010emergent adverse events were reported in five (16.7%) subjects when taking lemborexant and four (13.3%) subjects when taking placebo; treatment\u2010emergent adverse events were mostly mild. Lemborexant was well tolerated and did not adversely impact SpO<jats:sub>2<\/jats:sub> or apnea\u2013hypopnea index after single and multiple doses relative to placebo in subjects with moderate\u2010to\u2010severe chronic obstructive pulmonary disease.<\/jats:p>","DOI":"10.1111\/jsr.14334","type":"journal-article","created":{"date-parts":[[2024,9,13]],"date-time":"2024-09-13T00:29:09Z","timestamp":1726187349000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Respiratory safety of lemborexant in adult and elderly subjects with moderate\u2010to\u2010severe chronic obstructive pulmonary disease"],"prefix":"10.1111","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5318-5668","authenticated-orcid":false,"given":"Jocelyn Y.","family":"Cheng","sequence":"first","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0852-8067","authenticated-orcid":false,"given":"Daniel","family":"Lorch","sequence":"additional","affiliation":[{"name":"Teradan Clinical Trials LLC  Brandon Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9372-6967","authenticated-orcid":false,"given":"Nancy","family":"Hall","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0807-2167","authenticated-orcid":false,"given":"Margaret","family":"Moline","sequence":"additional","affiliation":[{"name":"Eisai Inc.  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