Overview
- The FDA added postmenopausal women up to age 65 to Addyi’s indication on December 15, 2025.
- The label retains alcohol precautions: wait at least two hours after drinking before dosing and skip a dose after three or more drinks due to fainting and low blood pressure risk.
- Addyi remains the only FDA‑approved oral treatment for hypoactive sexual desire disorder, with Vyleesi available as an as‑needed injectable since 2019.
- Clinicians note statistically significant but modest benefits versus placebo and advise a comprehensive approach that addresses relationship, hormonal and menopause-related factors.
- Experts welcome expanded eligibility yet question the 65-year cap, call for clearer user guidance for patients and prescribers, and anticipate broader insurance coverage.