
FDA approved flibanserin (Addyi) for treating frustrating low sexual desire in postmenopausal women under 65—the first approval of its kind for this population. An estimated 40% of women experience hypoactive sexual desire disorder (HSDD), the most common female sexual dysfunction, with postmenopausal women previously having no FDA-approved treatment options.
⚖️ PROFESSIONAL IMPACT
- FDA granted Priority Review designation, signaling agency recognition of HSDD as serious unmet medical need in postmenopausal population
- Approval based on largest clinical trials ever conducted in women’s sexual health, with safety/efficacy profile established since 2015 premenopausal approval
- Health Canada approved expanded use in 2021, providing international precedent for postmenopausal treatment safety and efficacy
- Treatment prescribed by more than 30,000 US healthcare professionals, suggesting established clinical familiarity despite previous age limitation
🎯 ACTION ITEMS
- Screen postmenopausal patients under 65 for HSDD using validated assessment tools during routine wellness visits
- Counsel patients on absolute alcohol restrictions: no alcohol within 2 hours of dosing; skip dose if 3+ drinks consumed
- Review contraindicated medications before prescribing, particularly HIV antiretrovirals, azole antifungals, and certain cardiovascular agents
- Document that liver disease is absolute contraindication and assess hepatic function before initiating therapy
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PATIENT EDUCATION
OBESITY/WEIGHT MANAGEMENT
EXERCISE/TRAINING
LEGAL MATTERS
GUIDELINES/RECOMMENDATIONS