{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T20:10:21Z","timestamp":1790021421315,"version":"4.0.1"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2023,11,9]],"date-time":"2023-11-09T00:00:00Z","timestamp":1699488000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100003725","name":"National Research Foundation of Korea","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003725","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Korea Government","award":["2022R1F1A1063144"],"award-info":[{"award-number":["2022R1F1A1063144"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,2,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Study Objectives<\/jats:title>\n                  <jats:p>Dual orexin receptor antagonists (DORAs) are emerging treatments for insomnia. This meta-analysis study aimed to assess the safety of FDA-approved DORAs (suvorexant, lemborexant, and daridorexant), focusing on narcolepsy-like symptoms associated with these drugs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Five prominent databases were searched to identify randomized controlled trials (RCTs) on this topic. Primary safety outcomes included treatment-emergent adverse events (TEAEs), treatment-related TEAEs, TEAEs leading to discontinuation, and serious TEAEs. Excessive daytime sleepiness (EDS), sleep paralysis, and hallucinations were categorized as adverse events (AEs)-related narcolepsy-like symptoms.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Eleven RCTs with 7703 patients were included. DORAs were associated with a higher risk of TEAEs (risk ratio [RR], 1.09; 95% confidence interval [CI], 1.03 to 1.15) and treatment-related TEAEs (RR, 1.69; 95% CI: 1.49 to 1.92) when compared to placebo. The DORA group exhibited a significantly higher risk of EDS (RR, 2.15; 95% CI: 1.02 to 4.52) and sleep paralysis (RR, 3.40; 95% CI: 1.18 to 9.80) compared to the placebo group.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This meta-analysis achieved a comparative evaluation of the clinical safety and tolerability of FDA-approved DORAs for primary insomnia, specifically focusing on AEs-related narcolepsy-like symptoms. This study contributes to understanding the safety profile of FDA-approved DORAs for treating insomnia.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/sleep\/zsad293","type":"journal-article","created":{"date-parts":[[2023,11,11]],"date-time":"2023-11-11T04:35:37Z","timestamp":1699677337000},"source":"Crossref","is-referenced-by-count":23,"title":["Clinical safety and narcolepsy-like symptoms of dual orexin receptor antagonists in patients with insomnia: a systematic review and meta-analysis"],"prefix":"10.1093","volume":"47","author":[{"given":"Hyun-jin","family":"Na","sequence":"first","affiliation":[{"name":"College of Pharmacy, Kyungsung University , Busan , Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5500-8841","authenticated-orcid":false,"given":"Nakyung","family":"Jeon","sequence":"additional","affiliation":[{"name":"College of Pharmacy and Research Institute for Drug Development, Pusan National University , Busan , Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4595-9376","authenticated-orcid":false,"given":"Christine E","family":"Staatz","sequence":"additional","affiliation":[{"name":"School of Pharmacy, University of Queensland, Pharmacy Australia Centre of Excellence , Brisbane, QLD , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4796-8564","authenticated-orcid":false,"given":"Nayoung","family":"Han","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Jeju National University , Jeju , Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9538-0565","authenticated-orcid":false,"given":"In-hwan","family":"Baek","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Kyungsung University , Busan , Republic of Korea"},{"name":"School of Pharmacy, University of Queensland, Pharmacy Australia Centre of Excellence , Brisbane, QLD , Australia"},{"name":"Functional Food and Drug Convergence Research Center, Industry-Academic Cooperation Foundation, Kyungsung University , Busan , Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,11,9]]},"reference":[{"issue":"8","key":"2024020814041059500_CIT0001","doi-asserted-by":"crossref","first-page":"997","DOI":"10.5665\/SLEEP.1150","article-title":"Nighttime insomnia symptoms and perceived health in the America Insomnia Survey (AIS)","volume":"34","author":"Walsh","year":"2011","journal-title":"Sleep."},{"issue":"2","key":"2024020814041059500_CIT0002","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1053\/smrv.2002.0186","article-title":"Epidemiology of insomnia: What we know and what we still need to learn","volume":"6","author":"Ohayon","year":"2002","journal-title":"Sleep Med Rev."},{"issue":"4","key":"2024020814041059500_CIT0003","doi-asserted-by":"crossref","first-page":"e13604","DOI":"10.1111\/jsr.13604","article-title":"Insomnia disorder: State of the science and challenges for the future","volume":"31","author":"Riemann","year":"2022","journal-title":"J Sleep Res."},{"key":"2024020814041059500_CIT0004","doi-asserted-by":"crossref","DOI":"10.1176\/appi.books.9780890425596","volume-title":"DSM-5 Task Force. 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