Flibanserin is NOT Appropriate for Adult Males
Flibanserin is FDA-approved exclusively for premenopausal women with hypoactive sexual desire disorder and should not be used in men for low libido or erectile dysfunction. 1
FDA-Approved Indication
- Flibanserin received FDA approval in August 2015 specifically for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women only. 2, 1
- The FDA drug label explicitly states: "ADDYI is not for use for the treatment of HSDD in women who have gone through menopause or in men." 1
- This medication is contraindicated for male sexual dysfunction of any type, including low libido and erectile dysfunction. 1
Why This Matters for Male Patients
- Flibanserin works as a multifunctional serotonin agonist/antagonist that acts centrally on neurotransmitters—it increases dopamine and norepinephrine while decreasing serotonin. 3, 4
- This mechanism was studied and approved only for female sexual desire disorders, not male sexual dysfunction. 5, 3
- The drug has never been studied in male populations for efficacy or safety. 6
Appropriate Male Sexual Dysfunction Management
For adult males with low libido and erectile dysfunction not caused by SSRIs, the treatment approach should include:
- Risk factor modification: smoking cessation, weight loss, increased physical activity, and avoiding excess alcohol. 6
- Psychological evaluation: addressing underlying anxiety, depression, or relationship issues through psychotherapy or sexual/couples counseling. 6
- Specialist referral: to urology or sexual health specialists for evidence-based male sexual dysfunction treatments. 6
- Phosphodiesterase type 5 inhibitors (PDE5i): such as sildenafil or tadalafil, which are the established first-line pharmacological treatments for male erectile dysfunction (not flibanserin). 5