Flibanserin hydrochlorideProduct ingredient for Flibanserin

Flibanserin is the first drug to be approved for hypoactive sexual desire disorder (HSDD) in premenopausal women by the FDA in August 2015. In February of 2018 Flibanserin was approved by Health Canada under the brand name Addyi for a similar indication as approved by the FDA. It was originally developed as an antidepressant medication by Boehringer Ingelheim, but showed lack of efficacy in trials and was further developed as a hypoactive sexual disorder drug by Sprout Pharmaceuticals. Flibanserin's mechanism of action is attributed to its high affinity for 5-HTA1 and 5-HTA2 receptors, displaying agonist activity on 5-HTA1 and antagonist on 5-HTA2, resulting in lowering of serotonin in the brain as well as an effect on increasing norepinephrine and dopamine neurotransmitters.

In December of 2025 the FDA expanded the age of the indication to include postmenopausal women, a first for the FDA and sexual health in that age group. ¹⁰