From the Guidelines
Flibanserin is not approved or recommended for use in men. This medication, sold under the brand name Addyi, is specifically FDA-approved only for premenopausal women with hypoactive sexual desire disorder. There are no established dosing regimens for men because clinical trials have not demonstrated efficacy for male sexual dysfunction, as noted in the guidelines from the National Comprehensive Cancer Network 1. The medication works by affecting brain neurotransmitters, particularly serotonin, dopamine, and norepinephrine, which influence sexual desire differently in women than in men.
Men with sexual desire issues should instead consider medications specifically tested and approved for male sexual dysfunction, such as:
- Sildenafil (Viagra)
- Tadalafil (Cialis)
- Vardenafil (Levitra) for erectile dysfunction Or seek evaluation for testosterone replacement if low testosterone is diagnosed, as suggested by the American College of Physicians 1. The fundamental difference lies in how sexual desire is regulated - male sexual dysfunction often involves blood flow and hormonal issues, while female hypoactive sexual desire disorder involves more complex neurochemical pathways that flibanserin targets. Men experiencing sexual desire problems should consult with a healthcare provider for appropriate evaluation and treatment options suited to their specific condition.
From the FDA Drug Label
ADDYI is not for use for the treatment of HSDD in women who have gone through menopause or in men. ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men. The answer is no, Flibanserin (Addyi) is not approved for use in men 2.
From the Research
Flibanserin Approval for Use in Men
- There is no evidence to suggest that Flibanserin (Addyi) is approved for use in men 3, 4, 5, 6, 7.
- All the studies found indicate that Flibanserin is approved for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women 3, 4, 5, 6, 7.
- The US Food and Drug Administration (FDA) approved Flibanserin for the treatment of HSDD in premenopausal women in 2015, but there is no mention of its approval for use in men 3, 4, 6, 7.
Studies on Flibanserin
- The studies reviewed focus on the efficacy and safety of Flibanserin in premenopausal women with HSDD, with no mention of its use in men 3, 4, 5, 6, 7.
- The studies report on the benefits and risks of Flibanserin in women, including increased satisfying sexual events and sexual desire, as well as adverse effects such as dizziness and somnolence 4, 5, 6, 7.
- There is no evidence to suggest that Flibanserin has been studied or approved for use in men, and therefore its safety and efficacy in this population are unknown 3, 4, 5, 6, 7.