{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T05:59:19Z","timestamp":1790315959111,"version":"4.1.0"},"reference-count":34,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,8,25]],"date-time":"2025-08-25T00:00:00Z","timestamp":1756080000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,8,25]],"date-time":"2025-08-25T00:00:00Z","timestamp":1756080000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Sleep Research"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Data from the REST\u2010ON trial were not available before the 2021 American Academy of Sleep Medicine (AASM) clinical practice guideline update, which included a literature review through August 2020. This post hoc analysis from REST\u2010ON assessed participants who achieved clinically significant improvements on individual AASM clinical significance thresholds (CSTs). Composites of the coprimary endpoints and a secondary endpoint were also analysed. Participants with narcolepsy aged \u2265\u200916\u2009years were randomised 1:1 to once\u2010nightly sodium oxybate (ON\u2010SXB) or placebo for 13\u2009weeks. Coprimary endpoints were mean sleep latency on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression of Improvement (CGI\u2010I) rating, and number of cataplexy episodes; secondary endpoints included the Epworth Sleepiness Scale (ESS) score. Outcomes with ON\u2010SXB treatment compared with baseline were assessed according to the CSTs, and for those who met CSTs, the proportions of participants who experienced clinically significant improvements on a composite of \u2265\u20092, \u2265\u20093, or 4 endpoints were calculated. For improvements from baseline with ON\u2010SXB at Week 13 (9\u2010g dose), mean sleep latency on the MWT increased 10.8\u2009min (CST, \u2265\u20092\u2010min increase), 92.8% rated improvement on the CGI\u2010I (CST, \u2265\u200933% of participants reporting improvement), reduction in number of cataplexy episodes was 60.8% reduction (CST, \u2265\u200925% reduction), and reduction in ESS score was \u22126.5 (CST, \u2265\u20092\u2010point decrease). At Weeks 3, 8 and 13, significantly more participants treated with ON\u2010SXB versus placebo experienced clinical improvements on \u2265\u20092, \u2265\u20093, or 4 endpoints (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009\u2264\u20090.05). These data demonstrate the robust efficacy of ON\u2010SXB across multiple clinically important narcolepsy symptoms per established CSTs, further supporting the use of ON\u2010SXB in clinical practice.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    This manuscript presents the results of a post hoc analysis from the REST\u2010ON clinical trial (NCT02720744).\n                  <\/jats:p>","DOI":"10.1111\/jsr.70189","type":"journal-article","created":{"date-parts":[[2025,8,25]],"date-time":"2025-08-25T07:35:50Z","timestamp":1756107350000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Once\u2010Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy"],"prefix":"10.1111","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4575-0000","authenticated-orcid":false,"given":"Luis E.","family":"Ortiz","sequence":"first","affiliation":[{"name":"Johns Hopkins Medical Institutions, Johns Hopkins All Children's Hospital  St. Petersburg Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4494-0195","authenticated-orcid":false,"given":"Anne Marie","family":"Morse","sequence":"additional","affiliation":[{"name":"Geisinger Commonwealth School of Medicine, Geisinger Medical Center, Janet Weis Children's Hospital  Danville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3993-2230","authenticated-orcid":false,"given":"Michael J.","family":"Thorpy","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Montefiore Medical Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9430-3752","authenticated-orcid":false,"given":"Clete A.","family":"Kushida","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine  Stanford California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6532-9278","authenticated-orcid":false,"given":"John","family":"Harsh","sequence":"additional","affiliation":[{"name":"Colorado Sleep Institute  Boulder Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Roth","sequence":"additional","affiliation":[{"name":"Sleep Disorders and Research Center, Henry Ford Health System  Detroit Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7375-5020","authenticated-orcid":false,"given":"Jennifer","family":"Gudeman","sequence":"additional","affiliation":[{"name":"Avadel Pharmaceuticals  Chesterfield Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0683-6506","authenticated-orcid":false,"given":"Yves","family":"Dauvilliers","sequence":"additional","affiliation":[{"name":"Sleep\u2010Wake Disorders Center, Department of Neurology, Gui\u2010De\u2010Chauliac Hospital, Institute for Neurosciences of Montpellier INM, INSERM University of Montpellier  Montpellier France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,25]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.8482"},{"key":"e_1_2_12_3_1","unstructured":"American Academy of Sleep Medicine.2024.\u201cPractice Standards.\u201dAmerican Academy of Sleep Medicine.https:\/\/aasm.org\/."},{"key":"e_1_2_12_4_1","unstructured":"Avadel CNS Pharmaceuticals.2024.\u201cLUMRYZ (Sodium Oxybate for Extended\u2010Release Oral Suspension CIII). Full Prescribing Information.\u201dChesterfield MO Avadel Pharmaceuticals."},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsad323"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000012272"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/ene.14888"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsaa206"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)60237-2"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsaa009"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000003787"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000007264"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsad152"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2024.09.024"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/MCP.0000000000000098"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40801-023-00351-9"},{"key":"e_1_2_12_17_1","unstructured":"Jazz Pharmaceuticals.2023a.\u201cXyrem (Sodium Oxybate). Full Prescribing Information.\u201dPalo Alto CA Jazz Pharmaceuticals Inc."},{"key":"e_1_2_12_18_1","unstructured":"Jazz Pharmaceuticals.2023b.\u201cXywav (Calcium Magnesium Potassium and Sodium Oxybate). 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