Among premenopausal women with hypoactive sexual desire disorder taking selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs), flibanserin was shown to be safe and did not negatively affect depression symptoms, according to the results of a study published in the Journal of Sexual Medicine.
In this randomized controlled trial (12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress; ClinicalTrials.gov identifier: NCT01040208), premenopausal women with mild or remitted depression who were receiving either SSRIs or SNRIs and who had decreased sexual desire and related distress were enrolled. Participants were randomly assigned to receive flibanserin 50 mg at bedtime for 2 weeks followed by flibanserin 100 mg for up to 10 weeks (n=73) or placebo for up to 12 weeks (n=38). Adverse events, symptoms of depression, and symptoms of anxiety were monitored throughout the study.
The study was terminated early because of discontinuation of the development of flibanserin, resulting in 8 or more weeks of treatment for 84.9% of patients in the flibanserin group and 94.7% of patients in the placebo group.
Adverse events that were more common in the flibanserin group compared with placebo included dry mouth (5.5% vs 2.6%), insomnia (5.5% vs 2.6%), back pain (4.1% vs 2.6%), and dizziness (4.1% vs 0.0%). No serious adverse events were reported.
Depression symptoms worsened for 6.9% of patients in the flibanserin group compared with 21.6% of patients in the placebo group. Depression was remitted at the end of the study period in 19.4% of patients in the flibanserin group compared with 10.8% in the placebo group.
Anxiety symptoms worsened for 1.4% of patients in the flibanserin group compared with 2.7% in the placebo group. Similarly, anxiety remission at study end was 16.4% in the flibanserin group compared with 2.7% in the placebo group.
The study authors concluded that flibanserin was “generally safe and well tolerated in premenopausal women with mild or remitted depression who were taking a serotonergic antidepressant.”
Clayton AH, Croft HA, Yuan J, Brown L, Kissling R. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. J Sex Med. 2018;15(1):43-51.