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This systematic review and meta\u2010analysis assessed its efficacy and tolerability in sleep outcomes compared to placebo. We systematically searched clinical trial registries (Cochrane Central, WHO ICTRP, ClinicalTrials.gov) and databases (MEDLINE, Embase, APA PsycINFO) up to February 16, 2025, for Randomised Controlled Trials (RCTs) comparing agomelatine with placebo that reported sleep\u2010related outcomes. Analyses were conducted using a random\u2010effects model on an intention\u2010to\u2010treat basis. Risk ratios (RR) were used for dichotomous outcomes, weighted mean differences (WMD) for continuous outcomes, and Hedge's adjusted g (SMD) when different scales were used. Primary outcomes included subjective and objective total sleep time, subjective sleep quality, and treatment\u2010emergent somnolence and insomnia. Subgroup and sensitivity analyses explored heterogeneity and assessed robustness. Twenty\u2010five RCTs with 6812 participants were included. No significant effect was found for objective total sleep time (MD\u2009=\u2009\u221215.73\u2009min, 95% CI: \u221249.68; 18.22), while subjective sleep quality improved more with agomelatine than placebo (SMD\u2009=\u20090.31, 95% CI: 0.21; 0.40). Agomelatine was associated with fewer incidents of insomnia (RR\u2009=\u20090.59, 95% CI: 0.39; 0.90) but more incidents of somnolence (RR\u2009=\u20091.34, 95% CI: 1.02; 1.75). Agomelatine was found to cause marginally more adverse effects than placebo (RR\u2009=\u20091.05, 95% CI: 1.00; 1.11). Overall, agomelatine appears to slightly improve sleep quality and is well\u2010tolerated and safe, although the limited data for many outcomes warrant cautious interpretation.<\/jats:p>","DOI":"10.1111\/jsr.70231","type":"journal-article","created":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T04:05:48Z","timestamp":1762142748000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Effects of Agomelatine on Sleep Across Populations: A Systematic Review and Meta\u2010Analysis"],"prefix":"10.1111","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-7721-0377","authenticated-orcid":false,"given":"Anastasios","family":"Stefanou","sequence":"first","affiliation":[{"name":"Second Department of Psychiatry, Department of Medicine, School of Health Sciences Aristotle University of Thessaloniki  Thessaloniki Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ioannis","family":"Anastasiou","sequence":"additional","affiliation":[{"name":"Medical School, University of Thessaly  Larisa Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4262-456X","authenticated-orcid":false,"given":"Panagiota","family":"Fallon","sequence":"additional","affiliation":[{"name":"Medical School, University of Thessaly  Larisa Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5666-2458","authenticated-orcid":false,"given":"Eleni","family":"Glarou","sequence":"additional","affiliation":[{"name":"Centre for Trials Research Cardiff University  Cardiff UK"},{"name":"Division of Population Medicine School of Medicine, Cardiff University  Cardiff UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikolaos","family":"Christodoulou","sequence":"additional","affiliation":[{"name":"Department of Psychiatry School of Medicine, University of Thessaly  Larissa Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas S.","family":"Lappas","sequence":"additional","affiliation":[{"name":"Department of Psychiatry School of Medicine, University of Thessaly  Larissa Greece"},{"name":"Department of Geriatric Psychiatry Aneurin Bevan University Health Board  Newport UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vasilios\u2010Panteleimon","family":"Bozikas","sequence":"additional","affiliation":[{"name":"Second Department of Psychiatry, Department of Medicine, School of Health Sciences Aristotle University of Thessaloniki  Thessaloniki Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Myrto T.","family":"Samara","sequence":"additional","affiliation":[{"name":"Department of Psychiatry School of Medicine, University of Thessaly  Larissa Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,2]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsmc.2020.11.002"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.books.9780890425596"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2215\u20100366(21)00390\u20104"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mad.2023.111899"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0000000000000404"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.14412\/2074\u20102711\u20102024\u20105\u201024\u201029"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881119864968"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470743386"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.2174\/138161209788168056"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.43215"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare7010001"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1461145713000679"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(22)00878\u20109"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.18433\/jpps33252"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms16011111"},{"key":"e_1_2_10_17_1","volume-title":"Cochrane Handbook for Systematic Reviews of Interventions (6.5)","author":"Deeks J. 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