{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T21:04:19Z","timestamp":1740171859343,"version":"3.37.3"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2023,1,4]],"date-time":"2023-01-04T00:00:00Z","timestamp":1672790400000},"content-version":"vor","delay-in-days":1212,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2019,9,10]],"date-time":"2019-09-10T00:00:00Z","timestamp":1568073600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2019,8,17]],"date-time":"2019-08-17T00:00:00Z","timestamp":1566000000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100014605","name":"Sage Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014605","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009427","name":"Acadia","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009427","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013595","name":"AMAG Pharmaceuticals, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013595","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013327","name":"Lundbeck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013327","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005147","name":"Random House","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005147","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100008644","name":"JDS","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008644","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013595","name":"AMAG","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013595","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011284","name":"Valeant","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011284","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006483","name":"AbbVie Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007819","name":"Allergan","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007819","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000801","name":"Bayer HealthCare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000801","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013050","name":"New England Research Institutes, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013050","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006483","name":"AbbVie Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007819","name":"Allergan","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007819","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013595","name":"AMAG Pharmaceuticals, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013595","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100002429","name":"Amgen Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004477","name":"US","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004477","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000801","name":"Bayer HealthCare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000801","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012351","name":"Mitsubishi Tanabe Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100012351","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005612","name":"Shionogi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005612","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["smoa.jsexmed.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2019,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Flibanserin, a treatment for hypoactive sexual desire disorder, carries warnings for increased risk of severe hypotension and syncope when used with alcohol. However, these warnings are not informed by studies that used flibanserin\u2019s recommended bedtime dosing because previous alcohol studies assessed flibanserin\u2019s safety during the day.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Aim<\/jats:title>\n                  <jats:p>The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking flibanserin at bedtime.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age\u00a0= 34.5 \u00b1 9.9 years; mean body mass index\u00a0= 25.2 \u00b1 3.4 kg\/m2) were dosed with flibanserin or placebo for 3 days to achieve steady-state plasma levels. In a clinical research unit, subjects (n\u00a0= 22) were provided 2 units of wine (150 mL\/unit; 12% ethanol content) or a nonalcoholic beverage with a standardized 3-course evening meal. Flibanserin 100 mg or placebo was administered at bedtime 2.5 hours after the end of the evening meal. On a separate day, subjects were provided the alternative beverage (\u00b1 alcohol) with the same evening meal and dosed with the same treatment (flibanserin or placebo) at bedtime. After a 5-day washout period, subjects crossed over to the other treatment arm and the protocol was repeated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Main Outcome Measure<\/jats:title>\n                  <jats:p>Adverse events (AEs) and vital signs were monitored.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the absence of ethanol, headaches and hypotension were the only AEs that occurred in \u22652 subjects after flibanserin dosing (placebo corrected rates were 17.4% and 8.7%, respectively). After ethanol consumption, the rate of hypotension after flibanserin dosing was no greater than with flibanserin or placebo after nonalcoholic beverage consumption. There were no instances of orthostatic hypotension or syncope and no serious AEs or AEs leading to study discontinuation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Flibanserin dosed at bedtime after moderate amounts of alcohol with an evening meal was well-tolerated with no evidence of clinically significant hypotension or syncope.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1016\/j.esxm.2019.08.003","type":"journal-article","created":{"date-parts":[[2019,9,10]],"date-time":"2019-09-10T13:00:42Z","timestamp":1568120442000},"page":"418-424","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects"],"prefix":"10.1093","volume":"7","author":[{"given":"Leah","family":"Millheiser","sequence":"first","affiliation":[{"name":"Stanford University School of Medicine , Palo Alto, CA, \u00a0 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anita H.","family":"Clayton","sequence":"additional","affiliation":[{"name":"University of Virginia School of Medicine , Charlottesville, VA, \u00a0 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon J.","family":"Parish","sequence":"additional","affiliation":[{"name":"Weill Cornell Medical College , New York, NY, \u00a0 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sheryl A.","family":"Kingsberg","sequence":"additional","affiliation":[{"name":"University Hospitals Cleveland Medical Center , Cleveland, OH, \u00a0 USA"},{"name":"MacDonald Women\u2019s Hospital , Cleveland, OH, \u00a0 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noel N.","family":"Kim","sequence":"additional","affiliation":[{"name":"Institute for Sexual Medicine , San Diego, CA, \u00a0 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James A.","family":"Simon","sequence":"additional","affiliation":[{"name":"George Washington University School of Medicine and IntimMedicine Specialists , Washington, DC, \u00a0 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2019,9,10]]},"reference":[{"key":"2023012006101980700_bib1","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1016\/j.mayocp.2017.11.002","article-title":"The International Society for the Study of Women's Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women","volume":"93","author":"Clayton","year":"2018","journal-title":"Mayo Clin Proc"},{"year":"2018","key":"2023012006101980700_bib2","article-title":"Addyi (flibanserin) tablets, for oral use [package insert in United States]"},{"year":"2018","key":"2023012006101980700_bib3","article-title":"Addyi (flibanserin) tablets, for oral use [product monograph in Canada]"},{"author":"Health Canada","key":"2023012006101980700_bib4","article-title":"Summary Basis of Decision for Addyi (May 2018)"},{"key":"2023012006101980700_bib5","doi-asserted-by":"crossref","first-page":"970","DOI":"10.1097\/AOG.0b013e3181898cdb","article-title":"Sexual problems and distress in United States women: Prevalence and correlates","volume":"112","author":"Shifren","year":"2008","journal-title":"Obstet Gynecol"},{"key":"2023012006101980700_bib6","first-page":"1888","article-title":"Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions-Part II","volume":"13","author":"Parish","year":"2016","journal-title":"J\u00a0Sex Med"},{"key":"2023012006101980700_bib7","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1111\/j.1527-3458.2002.tb00219.x","article-title":"Pharmacology of flibanserin","volume":"8","author":"Borsini","year":"2002","journal-title":"CNS Drug Rev"},{"key":"2023012006101980700_bib8","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1017\/S1461145702002869","article-title":"Region-dependent effects of flibanserin and buspirone on adenylyl cyclase activity in the human brain","volume":"5","author":"Marazziti","year":"2002","journal-title":"Int J Neuropsychopharmacol"},{"key":"2023012006101980700_bib9","first-page":"15","article-title":"Multifunctional pharmacology of flibanserin: Possible mechanism of therapeutic action in hypoactive sexual desire disorder","volume":"8","author":"Stahl","year":"2011","journal-title":"J\u00a0Sex Med"},{"key":"2023012006101980700_bib10","first-page":"1575","article-title":"Understanding the role of serotonin in female hypoactive sexual desire disorder and treatment options","volume":"14","author":"Croft","year":"2017","journal-title":"J\u00a0Sex Med"},{"key":"2023012006101980700_bib11","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1111\/jcpt.12563","article-title":"The pharmacodynamic effects of combined administration of flibanserin and alcohol","volume":"42","author":"Stevens","year":"2017","journal-title":"J\u00a0Clin Pharm Ther"},{"key":"2023012006101980700_bib12","article-title":"Effects of alcohol administered with flibanserin in healthy premenopausal women: A randomized, double-blind, single-dose, seven-way crossover study","author":"Sicard","year":"8\u221211, 2018","journal-title":"19th Annual Fall Scientific Meeting of SMSNA"},{"journal-title":"J Sex Med","article-title":"Effects of timing of flibanserin administration relative to alcohol intake in healthy premenopausal women: A randomized, double-blind, crossover study","author":"Simon","key":"2023012006101980700_bib13"},{"author":"National Institute on Alcohol Abuse and Alcoholism","key":"2023012006101980700_bib14","article-title":"What is a standard drink?"},{"key":"2023012006101980700_bib15","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1007\/BF02291236","article-title":"Consensus statement on the definition of orthostatic hypotension, pure autonomic failure and multiple system atrophy","volume":"6","author":"Kaufman","year":"1996","journal-title":"Clin Auton Res"},{"key":"2023012006101980700_bib16","doi-asserted-by":"crossref","first-page":"396","DOI":"10.1097\/gme.0b013e318230e286","article-title":"Characteristics of premenopausal and postmenopausal women with acquired, generalized hypoactive sexual desire disorder: The Hypoactive Sexual Desire Disorder Registry for women","volume":"19","author":"Rosen","year":"2012","journal-title":"Menopause"},{"key":"2023012006101980700_bib17","first-page":"1074","article-title":"Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the VIOLET study","volume":"9","author":"Derogatis","year":"2012","journal-title":"J\u00a0Sex Med"},{"key":"2023012006101980700_bib18","first-page":"793","article-title":"Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the DAISY study","volume":"9","author":"Thorp","year":"2012","journal-title":"J\u00a0Sex Med"},{"key":"2023012006101980700_bib19","first-page":"1807","article-title":"Efficacy of flibanserin in women with hypoactive sexual desire disorder: Results from the BEGONIA trial","volume":"10","author":"Katz","year":"2013","journal-title":"J\u00a0Sex Med"},{"key":"2023012006101980700_bib20","first-page":"57","article-title":"Gender differences in binge drinking","volume":"39","author":"Wilsnack","year":"2018","journal-title":"Alcohol Res"},{"key":"2023012006101980700_bib21","doi-asserted-by":"crossref","first-page":"140","DOI":"10.1016\/j.drugalcdep.2013.01.019","article-title":"Age, period, and cohort effects in heavy episodic drinking in the US from 1985 to 2009","volume":"132","author":"Keyes","year":"2013","journal-title":"Drug Alcohol Depend"},{"key":"2023012006101980700_bib22","doi-asserted-by":"crossref","first-page":"461","DOI":"10.1016\/j.sxmr.2017.06.003","article-title":"Flibanserin: From bench to bedside","volume":"5","author":"Dooley","year":"2017","journal-title":"Sex Med Rev"},{"author":"World Health Organization Definitions","key":"2023012006101980700_bib23"},{"year":"2019","key":"2023012006101980700_bib24","article-title":"Addyi (flibanserin) tablets, for oral use [updated package insert in United States]"}],"container-title":["Sexual Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2050116119301278?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2050116119301278?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/academic.oup.com\/smoa\/article-pdf\/7\/4\/418\/48791782\/smoa_7_4_418.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/smoa\/article-pdf\/7\/4\/418\/48791782\/smoa_7_4_418.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,20]],"date-time":"2023-01-20T06:12:43Z","timestamp":1674195163000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/smoa\/article\/7\/4\/418\/6956495"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,9,10]]},"references-count":24,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019,12,1]]}},"URL":"https:\/\/doi.org\/10.1016\/j.esxm.2019.08.003","relation":{},"ISSN":["2050-1161"],"issn-type":[{"type":"electronic","value":"2050-1161"}],"subject":[],"published-other":{"date-parts":[[2019,12]]},"published":{"date-parts":[[2019,9,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects","name":"articletitle","label":"Article Title"},{"value":"Sexual Medicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.esxm.2019.08.003","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2019 The Authors. Published by Elsevier Inc. on behalf of the International Society for Sexual Medicine.","name":"copyright","label":"Copyright"}]}}