Is Addyi (flibanserin) effective for treating Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women?

Efficacy of Addyi (Flibanserin) in Postmenopausal Women with HSDD

Although Addyi (flibanserin) is not FDA-approved for postmenopausal women, some clinical evidence suggests it can be effective and safe in treating Hypoactive Sexual Desire Disorder (HSDD) in this population. 1

Evidence for Postmenopausal Use

The NCCN Guidelines (2024) specifically note that while flibanserin is FDA-approved only for premenopausal women with HSDD, some data suggest it can be effective and safe in postmenopausal women as well 1. This is supported by clinical research:

• The PLUMERIA study, a randomized, double-blind, placebo-controlled trial in postmenopausal women with HSDD, found:

  • Significant improvement in Female Sexual Function Index desire domain (FSFI-d) scores compared to placebo (p=0.011)
  • The study was discontinued early by the sponsor, which affected the power to detect differences in satisfying sexual events 2

• The SNOWDROP trial (referenced in PLUMERIA) previously demonstrated efficacy of flibanserin in postmenopausal women with HSDD 2

Mechanism of Action and Expected Benefits

Flibanserin works by:

• Increasing dopamine and norepinephrine (responsible for sexual excitement)
• Decreasing serotonin (responsible for sexual inhibition) 3

In premenopausal women, flibanserin results in approximately one additional satisfying sexual event every two months 1. Similar modest benefits may be expected in postmenopausal women.

Safety Considerations

Common side effects include:

• Dizziness (6.4% in postmenopausal women)
• Somnolence/drowsiness (6.9%)
• Insomnia (7.7%)
• Nausea 2

These adverse events are typically mild to moderate and consistent with the drug's central nervous system activity 3, 4.

Alternative Options for HSDD in Postmenopausal Women

If flibanserin is not suitable, other options include:

• Off-label use of bupropion and buspirone 1
• Cognitive behavioral therapy
• Mindfulness meditation
• Pelvic floor therapy 5

For vaginal dryness that may contribute to sexual dysfunction:

• Non-hormonal vaginal moisturizers and water-based lubricants
• Vaginal estrogen therapy (if not contraindicated) 6

Clinical Approach

When considering flibanserin for postmenopausal women with HSDD:

1. Confirm diagnosis of HSDD (acquired, generalized lack of sexual desire causing distress)
2. Discuss the off-label nature of this use
3. Review potential side effects and drug interactions
4. Start at the standard dose of 100 mg daily at bedtime
5. Assess efficacy after 8-12 weeks of treatment
6. Monitor for adverse effects, particularly dizziness and somnolence

Important Caveats

• The FDA has not approved flibanserin for postmenopausal women
• Benefits are modest (similar to premenopausal women)
• Long-term safety data in postmenopausal women are limited 4
• Alcohol should be avoided when taking flibanserin due to increased risk of hypotension and syncope