Summary

This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

• Addyi (flibanserin) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.
• This summary is based on the review of four systematic review(s)/meta-analysis(es). ^[1-4]
• In premenopausal women with Hypoactive Sexual Desire Disorder (HSDD), flibanserin increased satisfying sexual events (SSEs) by 2.1 ± 0.14 over 28 days, compared to 1.2 ± 0.11 with placebo (p < 0.0001). Flibanserin also increased FSFI-d scores by 0.9 ± 0.04 versus 0.6 ± 0.04 with placebo (p < 0.0001) and decreased FSDS-R-13 scores by -0.9 ± 0.04 versus -0.6 ± 0.04 with placebo (p < 0.0001).
• Bremelanotide, while not directly compared numerically, was noted to improve desire, arousal, and orgasm scores in premenopausal women, suggesting a broader impact on sexual function than flibanserin, which primarily affects sexual desire and distress.
• Hormone therapy and testosterone showed effectiveness in improving sexual desire in menopausal women, but these were not directly comparable to flibanserin, which is indicated for premenopausal women with HSDD.
• The most common adverse events reported in premenopausal women with HSDD using flibanserin were dizziness and somnolence, occurring in ≥10% of patients, with additional concerns about hypotension, syncope, and sedation, particularly when combined with alcohol, as well as nausea, insomnia, and dry mouth.
• The safety profile of flibanserin includes similar incidences of hypotension, syncope, and sedation-related adverse events compared to serotonergic antidepressants, though these events occurred less frequently than with triptans. The risk of severe adverse events is notably increased with alcohol use, necessitating a boxed warning and contraindication.
• There is no population types or subgroups information available in the reviewed studies.