Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 100 mg) |
| Drug Class | Serotonin receptor 1A agonist and serotonin receptor 2A antagonists |
| 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.
Summary
- Flibanserin (Addyi) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). It acts as a 5-hydroxytryptamine 5-HT_1A agonist and 5-HT_2A antagonist to improve sexual desire and reduce distress related to the desire in this population.
- The information about flibanserin was derived from four studies. These sources provided comprehensive comparison data on safety and effectiveness between flibanserin and other treatments used for HSDD.
- Compared to hormone therapy, testosterone, and bremelanotide, which show broader efficacy in menopausal women or across more general symptoms of female sexual dysfunction (FSD), flibanserin's advantage lies in its targeted mechanism specifically designed for premenopausal women with HSDD.
- The safety profile of flibanserin includes adverse effects like hypotension, syncope, and sedation. Its side effect profile is somewhat similar to that of serotonergic antidepressants but has an increased risk when combined with alcohol consumption.
- While medications alone may not resolve FSD due to wide variability in treatment efficacy among different treatments, including flibanserin; hormonal treatments and psychological interventions show substantial improvement across multiple FSD domains especially in menopausal women indicating that a broader approach might be necessary for comprehensive FSD management beyond just medication usage such as Addyi.
- Subgroup considerations reveal consistent improvements across various demographics within the premenopausal group using Addyi; however, detailed subgroup analyses based on the duration of HSDD or concurrent psychiatric conditions were not available, leaving some questions regarding its efficacy within specific sub-populations within this group.
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 |
|---|---|---|
| Female sexual dysfunctions: an overview on the available therapeutic interventions. | 2022 | Minerva Obstetrics and Gynecology |
| Female sexual dysfunction: a systematic review of outcomes across various treatment modalities. | 2019 | Sexual Medicine Reviews |
| Flibanserin for premenopausal hypoactive sexual desire disorder: pooled analysis of clinical trials. | 2019 | Journal of Women's Health |
| Evaluation of flibanserin safety: comparison with other serotonergic medications. | 2019 | Sexual Medicine Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Management of hypoactive sexual desire disorder in transgender women: a guide for clinicians. | 2020 | International Journal of Impotence Research |
| Female hypoactive sexual desire disorder: a practical guide to causes, clinical diagnosis, and treatment. | 2020 | Journal of Women’s Health |
| 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 Proceedings |