Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 100 mg) |
| Drug Class | Serotonin modulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: a co-existing medical or psychiatric condition; problems within the relationship; or the effects of a medication or other drug substance.
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Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Satisfying Sexual Events (SSE): In premenopausal women, flibanserin 100 mg increased the mean number of SSE per month compared to placebo (mean difference (MD) 0.69, 95% confidence interval (CI) [0.39, 0.99]).
- Sexual Desire and Function Scores: Flibanserin significantly improved the eDiary sexual desire score (MD 1.71, 95% CI [0.43, 2.98]), Female Sexual Function Index (FSFI) desire domain (MD 0.30, 95% CI [0.29, 0.31]), and total FSFI score (MD 2.51, 95% CI [1.47, 3.55]) compared to placebo.
- Sexual Distress and Overall Improvement: Reductions were observed in Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (MD -0.30, 95% CI [-0.31, -0.29]) and FSDS-R total score (MD -3.30, 95% CI [-3.37, -3.23]), with increased odds of improvement in Patient's Global Impression of Improvement (PGI-I) score (OR 1.93, 95% CI [1.58, 2.36], P < .00001).
- Common Adverse Events: Flibanserin use was associated with increased risks of mild adverse events, including dizziness, fatigue, nausea, somnolence, and insomnia, compared to placebo, with no significant differences in the incidence of serious or severe adverse events between groups.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Addyi (flibanserin) Prescribing Information. | 2021 | Sprout Pharmaceuticals, Inc., Raleigh, NC |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Role of flibanserin in managing hypoactive sexual desire disorder in women: A systematic review and meta-analysis | 2024 | Medicine |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Treatments for postmenopausal hypoactive sexual desire disorder | 2020 | American Family Physician |
| The International Society for the Study of Women’s Sexual Health process of care for the identification of sexual concerns and problems in women | 2019 | Mayo Clinic |