{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T11:04:33Z","timestamp":1793271873575,"version":"4.5.0"},"reference-count":40,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T00:00:00Z","timestamp":1733270400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T00:00:00Z","timestamp":1733270400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100023368","name":"Eisai Canada","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/501100023368","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neuropsychopharm Rep"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Individuals with insomnia frequently have comorbid depression or anxiety. This study sought to provide a preliminary indication of the effects of lemborexant (LEM) in subjects treated for mild depression\/anxiety symptoms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>E2006\u2010G000\u2010303 (NCT02952820; EudraCT 2015\u2010001463\u201039; SUNRISE\u20102) was a 12\u2010month, phase 3, randomized, placebo\u2010controlled, double\u2010blind study where subjects with insomnia disorder were randomized (1:1:1) to placebo, LEM 5\u2009mg (LEM5), or LEM 10\u2009mg (LEM10) for 6\u2009months. During the second 6\u2009months (not reported), placebo\u2010treated subjects were re\u2010randomized to LEM5 or LEM10. In this post hoc analysis, changes from baseline (CFB) in subject\u2010reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Fatigue Severity Scale, and Insomnia Severity Index were evaluated in subjects treated with medications for symptoms of depression\/anxiety (subpopulation).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 949 randomized subjects, 61 treated with medications for symptoms of depression\/anxiety were included. In the subpopulation, CFB comparing LEM with placebo were generally smaller than the overall population due to a larger placebo response in the subpopulation. However, the magnitudes of CFB within the active treatment groups for sSOL, sWASO, sTST, and sSE were similar between the subpopulation and the overall population. No new safety signals were observed in the subpopulation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>LEM treatment benefited subjects with insomnia treated with medications for depression\/anxiety symptoms, with no new safety signals. A greater placebo response in the subpopulation than in the overall population decreased the drug versus placebo effect size for LEM, as has been reported for other insomnia medications.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/npr2.12509","type":"journal-article","created":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T23:23:52Z","timestamp":1733354632000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and safety of lemborexant in subjects with insomnia disorder receiving medications for depression or anxiety symptoms"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6702-781X","authenticated-orcid":false,"given":"Andrew","family":"Krystal","sequence":"first","affiliation":[{"name":"University of California  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9196-0706","authenticated-orcid":false,"given":"Pierre","family":"Blier","sequence":"additional","affiliation":[{"name":"The Royal Institute of Mental Health Research  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7655-0477","authenticated-orcid":false,"given":"Larry","family":"Culpepper","sequence":"additional","affiliation":[{"name":"Boston University School of Medicine  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2897-0458","authenticated-orcid":false,"given":"Andrew A.","family":"Nierenberg","sequence":"additional","affiliation":[{"name":"Dauten Family Center for Bipolar Treatment Innovation Massachusetts General Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9169-3249","authenticated-orcid":false,"given":"Yoshikazu","family":"Takaesu","sequence":"additional","affiliation":[{"name":"Department of Neuropsychiatry University of the Ryukyus  Okinawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1292-0897","authenticated-orcid":false,"given":"Naoki","family":"Kubota","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd.  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