Can Addyi (Flibanserin) Help in Postmenopausal Women?
No, Addyi (flibanserin) is NOT FDA-approved for postmenopausal women and should not be routinely used in this population, though emerging evidence suggests it may be effective off-label in select cases. 1
FDA Approval Status
The FDA label explicitly states that flibanserin is indicated only for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), and specifically notes that it is NOT indicated for the treatment of HSDD in postmenopausal women. 1 This represents the highest level regulatory guidance and should frame clinical decision-making.
Off-Label Evidence in Postmenopausal Women
Despite the FDA limitation, some data suggest potential efficacy:
The PLUMERIA trial (2017) demonstrated that flibanserin was generally well tolerated in naturally postmenopausal women and showed statistically significant improvement in the Female Sexual Function Index desire domain score compared to placebo (P = .011), though the study was terminated early by the sponsor. 2
The most common adverse events in postmenopausal women were insomnia (7.7%), somnolence (6.9%), and dizziness (6.4%), which are typical of centrally acting medications. 2
NCCN guidelines (2024) acknowledge that "although it is not FDA-approved for use in postmenopausal individuals, some data suggest that it can be effective and safe in the postmenopausal setting as well." 3
Clinical Context and Alternatives
The modest efficacy of flibanserin should be considered—it results in approximately 1 additional satisfying sexual event every 2 months in premenopausal women. 4, 5 This same modest benefit would be expected in postmenopausal women if used off-label.
For postmenopausal women with sexual dysfunction, prioritize FDA-approved and guideline-supported alternatives first:
Ospemifene (a SERM) is FDA-approved and effectively treats vaginal dryness and dyspareunia in postmenopausal women, though it should be avoided in those with estrogen-dependent cancers. 3
Vaginal estrogen, testosterone cream, or DHEA (prasterone) are effective options for vaginal atrophy and dyspareunia. 3
Non-hormonal vaginal moisturizers and lubricants remain first-line for many patients. 3
Key Clinical Caveats
The validity of using "satisfying sexual events" as an outcome measure in HSDD studies has been questioned, which was a limitation of the postmenopausal trials. 2
Flibanserin has not been evaluated in women with a history of cancer or those on endocrine therapy, and the risk/benefit ratio in these populations remains uncertain. 5
Common adverse effects (dizziness, somnolence, insomnia) may be more problematic in older postmenopausal women at higher risk for falls. 2