{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T18:40:19Z","timestamp":1791312019388,"version":"4.3.1"},"reference-count":57,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,3,13]],"date-time":"2025-03-13T00:00:00Z","timestamp":1741824000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100016198","name":"Idorsia Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100016198","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Sleep Research"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>\n                    This double\u2010blind, placebo\u2010controlled, two\u2010way crossover trial evaluated the efficacy and safety of daridorexant in patients with chronic insomnia and comorbid nocturia. In total, 60 patients aged \u226555\u2009years with insomnia complaints for \u22653\u2009months, Insomnia Severity Index (ISI) \u226513 and \u22653\u2009voids\/night for \u22651\u2009month were randomised (1:1) to daridorexant 50\u2009mg\/placebo for 4\u2009weeks followed by crossover after a 14\u201321\u2010day washout period. The primary endpoint was change from baseline to Week (W) 4 in self\u2010reported total sleep time (sTST). Other endpoints included change in ISI score, sleep depth and quality (visual analogue scale scores), nocturnal voids (mean number, time to first) and daytime functioning (Insomnia Daytime Symptoms and Impacts Questionnaire score [IDSIQ]). At W4, daridorexant significantly increased sTST versus placebo (least\u2010squares mean difference [LSMD] 20.9\u2009min, 95% confidence interval [CI] 8.0\u201333.7;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.002); significant improvements were also seen at W1\u20133. Compared with placebo, daridorexant significantly decreased (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001) ISI at both timepoints, W2 (LSMD \u22123.7, 95% CI \u22125.1 to \u22122.3) and W4 (LSMD \u22123.3, 95% CI \u22124.7 to \u22121.8) and significantly improved (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.05) sleep depth (W1, 2, 3, 4), sleep quality (W1, 2, 3) and IDSIQ total score (W1, 3). Daridorexant versus placebo reduced the number of voids (LSMD [95% CI]: W1\u20130.6 [\u22120.9 to \u22120.3],\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001; W4\u20130.3 [\u22120.7 to +0.1],\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.090) and increased median time to first void (difference to placebo, W1: +31\u2009min,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.0027; W4: +23\u2009min,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.2026). No adverse events of special interest (falls\/urinary incontinence) were reported during daridorexant treatment. In conclusion, in patients with chronic insomnia and nocturia, daridorexant improves both conditions with a favourable safety profile.\n                  <\/jats:p>","DOI":"10.1111\/jsr.70002","type":"journal-article","created":{"date-parts":[[2025,3,14]],"date-time":"2025-03-14T01:30:36Z","timestamp":1741915836000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A randomised crossover trial of daridorexant for the treatment of chronic insomnia and nocturia"],"prefix":"10.1111","volume":"34","author":[{"given":"Katharina","family":"Lederer","sequence":"first","affiliation":[{"name":"Advanced Sleep Research GmbH  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heike","family":"Benes","sequence":"additional","affiliation":[{"name":"Somni Bene Institut f\u00fcr Medizinische Forschung und Schlafmedizin Schwerin GmbH  Schwerin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Fine","sequence":"additional","affiliation":[{"name":"Clinical Research Center of Florida  Pompano Beach Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvia","family":"Shoffner","sequence":"additional","affiliation":[{"name":"Accellacare Research of Cary  Cary North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandro","family":"Bacchelli","sequence":"additional","affiliation":[{"name":"Encore Medical Research of Weston LLC  Weston Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David Castro","family":"Diaz","sequence":"additional","affiliation":[{"name":"Complejo Hospitalario Universitario de Canarias  Tenerife Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Emilio","family":"Batista","sequence":"additional","affiliation":[{"name":"Uroclinica Barcelona Centro M\u00e9dico Teknon  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Racheal","family":"Rowles","sequence":"additional","affiliation":[{"name":"Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias Di","family":"Marco","sequence":"additional","affiliation":[{"name":"Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Meinel","sequence":"additional","affiliation":[{"name":"Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,13]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2003.10.019"},{"key":"e_1_2_14_3_1","volume-title":"International classification of sleep disorders","author":"American Academy of Sleep Medicine","year":"2014"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2010.03.002"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jsr.12967"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0302-2838(22)00189-0"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.4364"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2019.07.005"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2014.02.057"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.25443"},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2018.12.007"},{"key":"e_1_2_14_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsae098"},{"key":"e_1_2_14_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-023-01020-9"},{"key":"e_1_2_14_14_1","first-page":"107","article-title":"Results of a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of Nocturia in adults with multiple sclerosis (MeNiMS)","volume":"18","author":"Drake M. J.","year":"2018","journal-title":"BioMed Research International"},{"key":"e_1_2_14_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4378"},{"key":"e_1_2_14_16_1","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0000000000000453"},{"key":"e_1_2_14_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12889-023-16329-9"},{"key":"e_1_2_14_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/bju.14183"},{"key":"e_1_2_14_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23917"},{"key":"e_1_2_14_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40271-020-00474-z"},{"key":"e_1_2_14_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2017.01.026"},{"key":"e_1_2_14_22_1","doi-asserted-by":"publisher","DOI":"10.2147\/PPA.S51482"},{"key":"e_1_2_14_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2018.04.050"},{"key":"e_1_2_14_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.peptides.2009.07.025"},{"key":"e_1_2_14_25_1","doi-asserted-by":"publisher","DOI":"10.1080\/15402002.2010.487450"},{"key":"e_1_2_14_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/32.8.1027"},{"key":"e_1_2_14_27_1","first-page":"601","article-title":"Daridorexant: First approval","volume":"82","author":"Markham A.","year":"2022","journal-title":"Drugs (New York)"},{"key":"e_1_2_14_28_1","doi-asserted-by":"publisher","DOI":"10.1136\/bcr-2020-239621"},{"key":"e_1_2_14_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(21)00436-1"},{"key":"e_1_2_14_30_1","doi-asserted-by":"publisher","DOI":"10.5173\/ceju.2011.04.art9"},{"key":"e_1_2_14_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2008.04.014"},{"key":"e_1_2_14_32_1","doi-asserted-by":"publisher","DOI":"10.2147\/NSS.S201994"},{"key":"e_1_2_14_33_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/34.5.601"},{"key":"e_1_2_14_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsmc.2022.03.003"},{"key":"e_1_2_14_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2019.05.009"},{"key":"e_1_2_14_36_1","doi-asserted-by":"publisher","DOI":"10.4236\/oju.2013.38055"},{"key":"e_1_2_14_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2010.05.093"},{"key":"e_1_2_14_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1569-9056(15)60542-5"},{"key":"e_1_2_14_39_1","doi-asserted-by":"publisher","DOI":"10.1111\/jsr.13628"},{"key":"e_1_2_14_40_1","doi-asserted-by":"publisher","DOI":"10.4111\/kju.2013.54.8.492"},{"key":"e_1_2_14_41_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000459"},{"key":"e_1_2_14_42_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40290-023-00484-w"},{"key":"e_1_2_14_43_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40290-023-00512-9"},{"key":"e_1_2_14_44_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsad077.0384"},{"key":"e_1_2_14_45_1","doi-asserted-by":"publisher","DOI":"10.3109\/07853890109002087"},{"key":"e_1_2_14_46_1","doi-asserted-by":"publisher","DOI":"10.1111\/jsr.14035"},{"key":"e_1_2_14_47_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.25602"},{"key":"e_1_2_14_48_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11255-007-9206-x"},{"key":"e_1_2_14_49_1","first-page":"17","article-title":"Efficacy and safety of the orexin receptor antagonist for patients with both insomnia and nocturia","volume":"81","author":"Suetomi T.","year":"2019","journal-title":"Nishinihon Journal of Urology"},{"key":"e_1_2_14_50_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2021.101519"},{"key":"e_1_2_14_51_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2009.03.080"},{"key":"e_1_2_14_52_1","doi-asserted-by":"publisher","DOI":"10.1111\/luts.12534"},{"key":"e_1_2_14_53_1","unstructured":"United States Census Bureau. (2021).Racial and Ethnic Diversity in the United States: 2010 Census and 2020 Census."},{"key":"e_1_2_14_54_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.10053"},{"key":"e_1_2_14_55_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2013.10.046"},{"key":"e_1_2_14_56_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007990903167415"},{"key":"e_1_2_14_57_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2005.10.054"},{"key":"e_1_2_14_58_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000009475"}],"container-title":["Journal of Sleep Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jsr.70002","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T07:05:24Z","timestamp":1762499124000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jsr.70002"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,13]]},"references-count":57,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1111\/jsr.70002"],"URL":"https:\/\/doi.org\/10.1111\/jsr.70002","archive":["Portico"],"relation":{},"ISSN":["0962-1105","1365-2869"],"issn-type":[{"value":"0962-1105","type":"print"},{"value":"1365-2869","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,13]]},"assertion":[{"value":"2024-11-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70002"}}