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Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects.
Sex Med 2019SM

Abstract

INTRODUCTION

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's recommended bedtime dosing because previous alcohol studies assessed flibanserin's safety during the day.

AIM

The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking flibanserin at bedtime.

METHODS

In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age = 34.5 ± 9.9 years; mean body mass index = 25.2 ± 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 = 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 (± 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.

MAIN OUTCOME MEASURE

Adverse events (AEs) and vital signs were monitored.

RESULTS

In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 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.

CONCLUSION

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. Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;XX:XXX-XXX.

Authors+Show Affiliations

Stanford University School of Medicine, Palo Alto, CA, USA.University of Virginia School of Medicine, Charlottesville, VA, USA.Weill Cornell Medical College, New York, NY, USA.University Hospitals Cleveland Medical Center, MacDonald Women's Hospital, Cleveland, OH, USA.Institute for Sexual Medicine, San Diego, CA, USA. Electronic address: nkim@ismlab.org.George Washington University School of Medicine and IntimMedicine Specialists, Washington, DC, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31519497

Citation

Millheiser, Leah, et al. "Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects." Sexual Medicine, 2019.
Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med. 2019.
Millheiser, L., Clayton, A. H., Parish, S. J., Kingsberg, S. A., Kim, N. N., & Simon, J. A. (2019). Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sexual Medicine, doi:10.1016/j.esxm.2019.08.003.
Millheiser L, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med. 2019 Sep 10; PubMed PMID: 31519497.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. AU - Millheiser,Leah, AU - Clayton,Anita H, AU - Parish,Sharon J, AU - Kingsberg,Sheryl A, AU - Kim,Noel N, AU - Simon,James A, Y1 - 2019/09/10/ PY - 2019/06/20/received PY - 2019/07/31/revised PY - 2019/08/14/accepted PY - 2019/9/15/entrez KW - Alcohol Interaction KW - Flibanserin KW - Hypoactive Sexual Desire Disorder KW - Hypotension KW - Syncope JF - Sexual medicine JO - Sex Med N2 - INTRODUCTION: 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's recommended bedtime dosing because previous alcohol studies assessed flibanserin's safety during the day. AIM: The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking flibanserin at bedtime. METHODS: In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age = 34.5 ± 9.9 years; mean body mass index = 25.2 ± 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 = 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 (± 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. MAIN OUTCOME MEASURE: Adverse events (AEs) and vital signs were monitored. RESULTS: In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 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. CONCLUSION: 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. Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;XX:XXX-XXX. SN - 2050-1161 UR - https://www.unboundmedicine.com/medline/citation/31519497/Safety_and_Tolerability_of_Evening_Ethanol_Consumption_and_Bedtime_Administration_of_Flibanserin_in_Healthy_Premenopausal_Female_Subjects L2 - https://linkinghub.elsevier.com/retrieve/pii/S2050-1161(19)30127-8 DB - PRIME DP - Unbound Medicine ER -