OBJECTIVE: To review data regarding flibanserin, a recently approved therapy for hypoactive sexual desire disorder (HSDD). DATA SOURCES: Literature search of MEDLINE (September 1995 to November 2015) was performed using the search term flibanserin. Reference lists from included articles were reviewed for pertinent citations. STUDY SELECTION AND DATA EXTRACTION: We included phase-3 trials of flibanserin as a treatment for HSDD. Four reports of phase-3 trials were included. One extension study of four phase-3 trials and one phase-2 pharmacokinetic trial were also included. DATA SYNTHESIS: Though a strong placebo response was demonstrated, flibanserin consistently, yet marginally, showed improvement (compared with placebo) in the number of satisfying sexual events per month. The most common adverse events were dizziness (11.4%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (2.4%). CONCLUSIONS: Flibanserin is effective in the treatment of HSDD. Flibanserin should be administered at bedtime to limit the risk for hypotension/syncope, accidental injury, and central nervous system (CNS) depression. Concomitant alcohol use contributes to significant CNS depression and hypotension/syncope with flibanserin and should be avoided according to the boxed warning. Careful patient assessment prior to the diagnosis of HSDD and the use of flibanserin is needed for safe use. Prescribing guidelines recommend discontinuing flibanserin at 8 weeks in the absence of benefit. Sexual dysfunction should be addressed in a patient-specific manner. Providers should exercise shared decision making in prescribing flibanserin for HSDD and discuss flibanserin's benefits and alternative options.
OBJECTIVE: To review data regarding flibanserin, a recently approved therapy for hypoactive sexual desire disorder (HSDD). DATA SOURCES: Literature search of MEDLINE (September 1995 to November 2015) was performed using the search term flibanserin. Reference lists from included articles were reviewed for pertinent citations. STUDY SELECTION AND DATA EXTRACTION: We included phase-3 trials of flibanserin as a treatment for HSDD. Four reports of phase-3 trials were included. One extension study of four phase-3 trials and one phase-2 pharmacokinetic trial were also included. DATA SYNTHESIS: Though a strong placebo response was demonstrated, flibanserin consistently, yet marginally, showed improvement (compared with placebo) in the number of satisfying sexual events per month. The most common adverse events were dizziness (11.4%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (2.4%). CONCLUSIONS:Flibanserin is effective in the treatment of HSDD. Flibanserin should be administered at bedtime to limit the risk for hypotension/syncope, accidental injury, and central nervous system (CNS) depression. Concomitant alcohol use contributes to significant CNS depression and hypotension/syncope with flibanserin and should be avoided according to the boxed warning. Careful patient assessment prior to the diagnosis of HSDD and the use of flibanserin is needed for safe use. Prescribing guidelines recommend discontinuing flibanserin at 8 weeks in the absence of benefit. Sexual dysfunction should be addressed in a patient-specific manner. Providers should exercise shared decision making in prescribing flibanserin for HSDD and discuss flibanserin's benefits and alternative options.