{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T05:58:17Z","timestamp":1791352697971,"version":"4.3.1"},"reference-count":79,"publisher":"Informa UK Limited","issue":"2","license":[{"start":{"date-parts":[[2021,11,24]],"date-time":"2021-11-24T00:00:00Z","timestamp":1637712000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011096","name":"Jazz Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011096","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.tandfonline.com"],"crossmark-restriction":true},"short-container-title":["Expert Opinion on Drug Discovery"],"published-print":{"date-parts":[[2022,2,1]]},"DOI":"10.1080\/17460441.2022.1999226","type":"journal-article","created":{"date-parts":[[2021,11,24]],"date-time":"2021-11-24T12:19:23Z","timestamp":1637756363000},"page":"109-119","update-policy":"https:\/\/doi.org\/10.1080\/tandf_crossmark_01","source":"Crossref","is-referenced-by-count":24,"title":["Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia"],"prefix":"10.1080","volume":"17","author":[{"given":"Gunjan","family":"Junnarkar","sequence":"first","affiliation":[{"name":"Pharmaceutical Development and Manufacturing Science, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clark","family":"Allphin","sequence":"additional","affiliation":[{"name":"New Product and Technology Integration, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judi","family":"Profant","sequence":"additional","affiliation":[{"name":"Medical Affairs, Global Molecule Team, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa L.","family":"Steininger","sequence":"additional","affiliation":[{"name":"Medical Communications, Global Scientific Affairs, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cuiping","family":"Chen","sequence":"additional","affiliation":[{"name":"Neuroscience Clinical Pharmacology, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Zomorodi","sequence":"additional","affiliation":[{"name":"Early Development and Clinical Pharmacology, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Skowronski","sequence":"additional","affiliation":[{"name":"Clinical Development, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jed","family":"Black","sequence":"additional","affiliation":[{"name":"Stanford University Center for Sleep Sciences and Medicine, Palo Alto, CA, USA"},{"name":"Sleep and CNS Medicine, Jazz Pharmaceuticals, Inc., Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"301","published-online":{"date-parts":[[2021,11,24]]},"reference":[{"key":"cit0001","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2014.02.001"},{"key":"cit0002","first-page":"125","volume-title":"Narcolepsy and Hypersomnia","author":"Ohayon MM.","year":"2007"},{"key":"cit0003","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsmc.2010.08.007"},{"key":"cit0004","volume-title":"International Classification of Sleep Disorders","author":"American Academy of Sleep Medicine","year":"2014","edition":"3"},{"key":"cit0005","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-018-36942-8"},{"key":"cit0006","doi-asserted-by":"publisher","DOI":"10.1111\/j.1750-3639.2003.tb00033.x"},{"key":"cit0007","unstructured":"Xyrem\u00ae (sodium oxybate) oral solution, CIII [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2020."},{"key":"cit0008","unstructured":"Wakix [package insert]. Plymouth Meeting, PA: Harmony Biosciences; 2021."},{"key":"cit0009","doi-asserted-by":"crossref","first-page":"e13387","DOI":"10.1111\/jsr.13387","author":"Bassetti CLA","year":"2021","journal-title":"J Sleep Res"},{"key":"cit0010","volume-title":"International Classification of Sleep Disorders","author":"American Academy of Sleep Medicine. Idiopathic Hypersomnia","year":"2014"},{"key":"cit0011","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2015.08.007"},{"key":"cit0012","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsmc.2017.03.009"},{"key":"cit0013","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-019-0948-2"},{"key":"cit0014","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2016.04.004"},{"key":"cit0015","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2017.11.1125"},{"key":"cit0016","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.2706"},{"key":"cit0017","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2013.03.002"},{"key":"cit0018","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2021.101440"},{"key":"cit0019","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0038977"},{"key":"cit0020","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.1738"},{"key":"cit0021","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2013.12.005"},{"key":"cit0022","doi-asserted-by":"publisher","DOI":"10.1097\/00004872-200211000-00017"},{"key":"cit0023","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.09.061"},{"key":"cit0024","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsab072.496"},{"key":"cit0025","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/30.12.1705"},{"key":"cit0026","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2006.01473.x"},{"key":"cit0027","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/29.7.939"},{"issue":"1","key":"cit0028","first-page":"31","volume":"26","author":"U.S. Xyrem Multicenter Study Group","year":"2003","journal-title":"Sleep"},{"key":"cit0029","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2003.11.002"},{"key":"cit0030","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2005.03.010"},{"key":"cit0031","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-4642(18)30133-0"},{"key":"cit0032","unstructured":"European Medicines Agency. Xyrem (sodium oxybate) medicine overview2021. [cited 2021 Sept 17]. Available at: https:\/\/www.ema.europa.eu\/en\/documents\/overview\/xyrem-epar-medicine-overview_en.pdf"},{"key":"cit0033","volume-title":"Presented at: Biennial Congress of the International Pediatric Sleep Association","author":"Morse AM","year":"2021"},{"key":"cit0034","unstructured":"Scientific Working Group for the Analysis of Seized Drugs. Gamma-Hydroxybutyrate\/Butyric Acid [product monograph]. 2005. [cited 2021 Oct 1]. Available at: https:\/\/www.swgdrug.org\/Monographs\/GAMMA-HYDROXYBUTYRATE.pdf"},{"key":"cit0035","doi-asserted-by":"publisher","DOI":"10.1016\/0028-3908(64)90074-7"},{"key":"cit0036","unstructured":"Xyrem\u00ae (sodium oxybate) oral solution CII [prescribing information]. Minnetonka, MN: Orphan Medical Inc. 2002."},{"key":"cit0037","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.111.641043"},{"key":"cit0038","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b4567"},{"key":"cit0039","volume-title":"Sodium intake in populations: assessment of evidence","author":"Institute of Medicine","year":"2013"},{"key":"cit0040","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)11911-8"},{"key":"cit0041","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1304127"},{"key":"cit0042","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000437740.48606.d1"},{"key":"cit0043","unstructured":"Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) oral solution, CIII [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2021."},{"key":"cit0044","unstructured":"Allphin CP, DesJardin M. Gamma-hydroxybutyrate compositions and their use for the treatment of disorders (USPatent No. US 8,591,922 B1) 2013. [cited 2021 May 10]. Available at: https:\/\/patentimages.storage.googleapis.com\/3f\/cc\/e3\/7ad26172c49c65\/US8591922.pdf"},{"key":"cit0045","doi-asserted-by":"publisher","DOI":"10.1517\/17425255.1.2.175"},{"key":"cit0046","doi-asserted-by":"publisher","DOI":"10.1016\/S0024-3205(02)01553-9"},{"key":"cit0047","volume-title":"Dietary Reference Intakes: The Essential Guide to Nutrient Requirements","author":"Institute of Medicine","year":"2006"},{"key":"cit0048","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13087"},{"key":"cit0049","volume-title":"Presented at: Annual AAPS PharmSci","volume":"360","author":"Wang Q","year":"2020"},{"key":"cit0050","doi-asserted-by":"publisher","DOI":"10.1152\/ajpcell.00112.2005"},{"key":"cit0051","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsaa206"},{"key":"cit0052","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsaa056.748"},{"key":"cit0053","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsaa056.749"},{"key":"cit0054","volume-title":"Presented at: Annual Meeting of the Associated Professional Sleep Societies","author":"Dauvilliers Y","year":"2021"},{"key":"cit0055","unstructured":"Jazz Pharmaceuticals. Jazz pharmaceuticals announces U.S. FDA approval of Xywav\u2122 (calcium, magnesium, potassium, and sodium oxybates) oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy [press release]. 2020. [cited 2021 Feb 4]. Available at: https:\/\/investor.jazzpharma.com\/news-releases\/news-release-details\/jazz-pharmaceuticals-announces-us-fda-approval-xywavtm-calcium"},{"key":"cit0056","unstructured":"US Food and Drug Administration. Clinical superiority findings. 2021. [cited 2021 Jul 9]. Available at: https:\/\/www.fda.gov\/industry\/designating-orphan-product-drugs-and-biological-products\/clinical-superiority-findings"},{"key":"cit0057","unstructured":"Jazz Pharmaceuticals announces positive top-line results from phase 3 study of Xywav\u2122 (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia [press release]. 2020. [cited 2020 Oct 8]. Available at: http:\/\/investor.jazzpharma.com\/news-releases\/news-release-details\/jazz-pharmaceuticals-announces-positive-top-line-results-phase-0\/"},{"key":"cit0058","author":"Dauvilliers Y","year":"2021","journal-title":"Lancet Neurol"},{"key":"cit0059","volume-title":"Presented at: Annual Meeting of the American Neurological Association","author":"Foldvary-Schaefer N","year":"2021"},{"key":"cit0060","unstructured":"US Food and Drug Aministration. FDA grants first of its kind indication for chronic sleep disorder treatment [press release]. 2021. [cited 2021 Sept 17]. Available at: https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-first-its-kind-indication-chronic-sleep-disorder-treatment"},{"key":"cit0061","doi-asserted-by":"publisher","DOI":"10.1007\/s40801-020-00223-6"},{"key":"cit0062","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2018.1417385"},{"key":"cit0063","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsmc.2019.05.007"},{"key":"cit0064","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2020.08.034"},{"key":"cit0065","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.9326"},{"key":"cit0066","unstructured":"European Medicines Agency. Committee for Medicinal Products for Human Use. Questions and answers on sodium in the context of the revision of the guideline on \u2018Excipients in the label and package leaflet of medicinal products for human use\u2019 (CPMP\/463\/00 Rev.1). 2015. [cited 2019 Jul 1]. Available at: https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/draft-questions-answers-sodium-context-revision-guideline-excipients-label-package-leaflet-medicinal_en.pdf"},{"key":"cit0067","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.312.7041.1249"},{"key":"cit0068","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1311989"},{"key":"cit0069","doi-asserted-by":"publisher","DOI":"10.1161\/HYPERTENSIONAHA.110.168054"},{"key":"cit0070","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200101043440101"},{"key":"cit0071","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f1326"},{"key":"cit0072","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39147.604896.55"},{"issue":"6","key":"cit0073","first-page":"e13","volume":"71","author":"Whelton PK","year":"2018","journal-title":"Hypertension"},{"key":"cit0074","volume-title":"Dietary Reference Intakes for Sodium and Potassium","author":"National Academies of Sciences Engineering and Medicine","year":"2019"},{"key":"cit0075","volume-title":"Guideline: Sodium Intake for Adults and Children","author":"World Health Organization","year":"2012"},{"key":"cit0076","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0180634"},{"key":"cit0077","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f6954"},{"key":"cit0078","volume-title":"Presented at: Annual Meeting of the American Academy of Neurology","author":"Dauvilliers Y","year":"2021"},{"issue":"23","key":"cit0079","first-page":"4654","volume":"19","author":"Busard\u00f2 FP","year":"2015","journal-title":"Eur Rev Med Pharmacol Sci"}],"container-title":["Expert Opinion on Drug Discovery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.tandfonline.com\/doi\/pdf\/10.1080\/17460441.2022.1999226","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,12]],"date-time":"2023-11-12T21:22:58Z","timestamp":1699824178000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/17460441.2022.1999226"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,24]]},"references-count":79,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2022,2,1]]}},"alternative-id":["10.1080\/17460441.2022.1999226"],"URL":"https:\/\/doi.org\/10.1080\/17460441.2022.1999226","relation":{},"ISSN":["1746-0441","1746-045X"],"issn-type":[{"value":"1746-0441","type":"print"},{"value":"1746-045X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,24]]},"assertion":[{"value":"The publishing and review policy for this title is described in its Aims & Scope.","order":1,"name":"peerreview_statement","label":"Peer Review Statement"},{"value":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=iedc20","URL":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=iedc20","order":2,"name":"aims_and_scope_url","label":"Aim & Scope"},{"value":"2020-12-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-10-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-11-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}