{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:10:01Z","timestamp":1787008201244,"version":"build-2736575974"},"reference-count":40,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Palliative Medicine"],"published-print":{"date-parts":[[2024,10,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Sleep disturbance has a prevalence of 30\u201378% in patients with advanced cancer. While pharmacotherapy is common, randomized controlled studies (RCTs) investigating available agents are limited. This study examines the efficacy and safety of temazepam or melatonin versus placebo for sleep in advanced cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This is a multicenter, randomized, double-blind, placebo-controlled study of temazepam, melatonin prolonged release (PR) or placebo for insomnia in patients with advanced cancer, and an insomnia severity index (ISI) score of &gt;11.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Twenty-one participants were randomized: nine to temazepam, eight to melatonin, and four to placebo. Baseline characteristics between groups were similar. The adjusted mean difference in day 8 ISI score versus placebo was \u22129.1 (95% confidence interval [CI] \u221217.5, 0.7,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.04) for temazepam and \u22129.6 (95% CI \u221218,\u22121.2,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.03) for melatonin PR. There was no improvement in global quality of life. Both agents were well tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Temazepam and melatonin PR were associated with a clinically significant improvement in patient-reported insomnia severity compared with placebo. Findings need confirmation with larger patient numbers.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jpm.2024.0151","type":"journal-article","created":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T19:59:40Z","timestamp":1726862380000},"page":"1368-1373","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["Temazepam or Melatonin Versus Placebo for the Treatment of Insomnia in Advanced Cancer: A Three-Arm, Double-Blind, Phase III, Multicenter, Randomized Clinical Trial"],"prefix":"10.1177","volume":"27","author":[{"given":"Ruwani","family":"Mendis","sequence":"first","affiliation":[{"name":"Department of Cancer Services, Western Health, Melbourne, Australia, Honorary Fellow, The University of Melbourne, Melbourne, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6507-1219","authenticated-orcid":false,"given":"Aaron","family":"Wong","sequence":"additional","affiliation":[{"name":"Peter MacCallum Cancer Centre, Melbourne, Australia, The Royal Melbourne Hospital Melbourne, Australia and The University of Melbourne, Melbourne, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Frenkel","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Sleep Disorders Medicine, Western Health, Melbourne, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Marie","family":"Southcott","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Sleep Disorders Medicine, Western Health, Melbourne, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris J.","family":"Selman","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology and Biostatistics Unit, Murdoch Children\u2019s Research Institute, Parkville, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Martin","sequence":"additional","affiliation":[{"name":"School of Medicine and Public Health, The University of Newcastle, NSW, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anneke","family":"Grobler","sequence":"additional","affiliation":[{"name":"Murdoch Children\u2019s Research Institute, Melbourne, Australia and The Department of Paediatrics, The University of Melbourne, Melbourne, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Currow","sequence":"additional","affiliation":[{"name":"Graduate School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meera","family":"Agar","sequence":"additional","affiliation":[{"name":"Palliative Medicine, University of Technology Sydney (UTS), Sydney, Australia, Centre for Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Sydney, Australia and the Southwest Sydney Local Health District Palliative Care Service, Sydney, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Le","sequence":"additional","affiliation":[{"name":"The Royal Melbourne Hospital, Melbourne, Australia, Peter MacCallum Cancer Centre, Melbourne, Australia, The University of Melbourne, Melbourne, Australia, University of Technology Sydney (UTS), Sydney, Australia and the Palliative Care Clinical Studies Collaborative, Sydney, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3312-0645","authenticated-orcid":false,"given":"Jennifer","family":"Philip","sequence":"additional","affiliation":[{"name":"Palliative Medicine, Centre for Cancer Research, Faculty of Medicine, Dentistry and Health Sciences, St Vincent\u2019s Hospital and The University of Melbourne, Melbourne, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,10,16]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-016-3524-4"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2015.06.018"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-004-0623-4"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/ijcp.14521"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2001.19.3.895"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0277-9536(01)00043-0"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1080\/00223980.1983.9915403"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.13.9006"},{"issue":"5","key":"e_1_3_5_10_2","first-page":"349","article-title":"Pathogenesis and management of cancer-related insomnia","volume":"3","author":"Graci G","year":"2005","unstructured":"Graci G. Pathogenesis and management of cancer-related insomnia. J Support Oncol, 2005; 3(5):349\u2013359.","journal-title":"J Support Oncol"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1098-3597(05)80002-X"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.2408-18.2018"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2015.02.003"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/30.5.574"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1111\/jebm.12485"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2023.102047"},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2014.03.008"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdt506"},{"issue":"1","key":"e_1_3_5_19_2","first-page":"60","article-title":"Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial","volume":"31","author":"Jakobsen G","year":"2022","unstructured":"Jakobsen G, , Sjue K, , Paulsen O, et al. Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial. Support Care Cancer, 2022; 31(1):60.","journal-title":"Support Care Cancer"},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-018-3088-3"},{"key":"e_1_3_5_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10549-014-2944-4"},{"key":"e_1_3_5_22_2","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/416531"},{"key":"e_1_3_5_23_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0231379"},{"key":"e_1_3_5_24_2","doi-asserted-by":"publisher","DOI":"10.4103\/0973-1075.185039"},{"key":"e_1_3_5_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/0163-8343(94)90118-X"},{"key":"e_1_3_5_26_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-010-1052-1"},{"key":"e_1_3_5_27_2","doi-asserted-by":"publisher","DOI":"10.32598\/bcn.12.1.1650.2"},{"key":"e_1_3_5_28_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy147"},{"key":"e_1_3_5_29_2","doi-asserted-by":"publisher","DOI":"10.1191\/0269216304pm879oa"},{"key":"e_1_3_5_30_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2869.2007.00613.x"},{"key":"e_1_3_5_31_2","doi-asserted-by":"publisher","DOI":"10.1185\/030079907X233098"},{"key":"e_1_3_5_32_2","doi-asserted-by":"publisher","DOI":"10.1097\/YIC.0b013e32832e9b08"},{"issue":"5","key":"e_1_3_5_33_2","first-page":"337","article-title":"Controlled release melatonin (Circadin) in the treatment of insomnia in older patients: Efficacy and safety in patients with history of use and non-use of hypnotic drugs","volume":"148","author":"Zisapel N","year":"2009","unstructured":"Zisapel N. Controlled release melatonin (Circadin) in the treatment of insomnia in older patients: Efficacy and safety in patients with history of use and non-use of hypnotic drugs. Harefuah, 2009; 148(5):337\u2013341, 348.","journal-title":"Harefuah"},{"key":"e_1_3_5_34_2","unstructured":"2023 Therapeutic guidelines limited. ISSN 2653-2557. Psychotropic: Insomnia in adults: Pharmacological treatment for insomnia in adults. Available from https:\/\/tgldcdp.tg.org.au.acs.hcn.com.au\/"},{"key":"e_1_3_5_35_2","doi-asserted-by":"publisher","DOI":"10.1002\/pon.860"},{"key":"e_1_3_5_36_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/34.5.601"},{"key":"e_1_3_5_37_2","doi-asserted-by":"publisher","DOI":"10.1191\/0269216306pm1133xx"},{"key":"e_1_3_5_38_2","doi-asserted-by":"publisher","DOI":"10.3109\/00207459008994241"},{"key":"e_1_3_5_39_2","unstructured":"Available from: https:\/\/mcri.figshare.com\/articles\/media\/INCA_study_Statistical_Analysis_Plan\/22152422\/1"},{"key":"e_1_3_5_40_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"issue":"5","key":"e_1_3_5_41_2","first-page":"649","article-title":"Meta-analysis of benzodiazepine use in the treatment of acute alcohol withdrawal","volume":"160","author":"Holbrook AM","year":"1999","unstructured":"Holbrook AM, , Crowther R, , Lotter A, et al. Meta-analysis of benzodiazepine use in the treatment of acute alcohol withdrawal. CMAJ, 1999; 160(5):649\u2013655.","journal-title":"CMAJ"}],"container-title":["Journal of Palliative Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/jpm.2024.0151","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jpm.2024.0151","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jpm.2024.0151","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T17:21:27Z","timestamp":1777656087000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/jpm.2024.0151"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,1]]},"references-count":40,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2024,10,1]]}},"alternative-id":["10.1089\/jpm.2024.0151"],"URL":"https:\/\/doi.org\/10.1089\/jpm.2024.0151","relation":{},"ISSN":["1096-6218","1557-7740"],"issn-type":[{"value":"1096-6218","type":"print"},{"value":"1557-7740","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,1]]}}}