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Existing approved medications are only modestly effective with many patients failing to benefit from these therapies. Therefore, there is a pressing need for other effective treatments with a different mechanism of action, especially for patients with very high (VH) drinking risk levels (DRL) because this is the most severely affected population of alcohol use disorder patients. Life expectancy of alcohol\u2010dependent patients with a VH DRL is reduced by 22\u00a0years compared with the general population and approximately 90\u00a0000 alcohol\u2010dependent subjects with a VH DRL die prematurely each year in the EU (Rehm <jats:italic>et al<\/jats:italic>. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#adb12645-bib-0046\"\/>). A promising new medication for this population is sodium oxybate, a compound that acts on GABA<jats:sub>B<\/jats:sub> receptors and extrasynaptic GABA<jats:sub>A<\/jats:sub> receptors resulting in alcohol\u2010mimetic effects. In this article, a European expert group of alcohol researchers and clinicians summarizes data (a) from published trials, (b) from two new\u2014as yet unpublished\u2014large clinical trials (GATE 2 (<jats:italic>n<\/jats:italic>\u00a0=\u00a0314) and SMO032 (<jats:italic>n<\/jats:italic>\u00a0=\u00a0496), (c) from post hoc subgroup analyses of patients with different WHO\u2010defined DRLs and (d) from multiple meta\u2010analyses. These data provide convergent evidence that sodium oxybate is effective especially in a subgroup of alcohol\u2010dependent patients with VH DRLs. Depending on the study, abstinence rates are increased up to 34 percent compared with placebo with risk ratios up to 6.8 in favor of sodium oxybate treatment. These convergent data are supported by the clinical use of sodium oxybate in Austria and Italy for more than 25\u00a0years. Sodium oxybate is the sodium salt of \u03b3\u2010hydroxybutyric acid that is also used as a recreational (street) drug suggestive of abuse potential. However, a pharmacovigilance database of more than 260\u00a0000 alcohol\u2010dependent patients treated with sodium oxybate reported very few adverse side effects and only few cases of abuse. We therefore conclude that sodium oxybate is an effective, well\u2010tolerated and safe treatment for withdrawal and relapse prevention treatment, especially in alcohol\u2010dependent patients with VH DRL.<\/jats:p>","DOI":"10.1111\/adb.12645","type":"journal-article","created":{"date-parts":[[2018,7,19]],"date-time":"2018-07-19T01:14:11Z","timestamp":1531962851000},"page":"969-986","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":75,"title":["Efficacy and safety of sodium oxybate in alcohol\u2010dependent patients with a very high drinking risk level"],"prefix":"10.1111","volume":"23","author":[{"given":"Wim","family":"van den Brink","sequence":"first","affiliation":[{"name":"Department of Psychiatry, Academic Medical Center University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Addolorato","sequence":"additional","affiliation":[{"name":"Alcohol Use Disorder Unit, Department of Internal Medicine, Gastroenterology and Hepatology Catholic University of Rome, A. Gemelli Hospital  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henri\u2010Jean","family":"Aubin","sequence":"additional","affiliation":[{"name":"French Institute of Health and Medical Research, Centre de Recherche en Epid\u00e9miologie et Sant\u00e9 des Populations (CESP)  Paris France"},{"name":"Addiction Research and Treatment Center, Paul Brousse Hospital, Paris\u2010Sud University  Villejuif France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amine","family":"Benyamina","sequence":"additional","affiliation":[{"name":"Addiction Research and Treatment Center, Paul Brousse Hospital, Paris\u2010Sud University  Villejuif France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Caputo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, SS Annunziata Hospital  Cento (Ferrara) 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