Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 100 mg) |
Drug Class | Sexual Disorder Agents |
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.
Latest News
![loading GIF](/img/news-loading.gif)
Summary
- Flibanserin (Addyi) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), characterized by low sexual desire causing marked distress or interpersonal difficulty.
- Four studies were reviewed to gather information about this drug's safety and effectiveness in comparison to other treatments for female sexual dysfunction (FSD).
- The analysis shows that flibanserin improves sexual desire and reduces related distress in premenopausal women. It demonstrates significant improvements supported by data pooled from three pivotal trials.
- Compared to hormonal therapies and psychotherapeutic interventions, flibanserin offers a pharmacological option directly targeting HSDD in premenopausal women. However, it does not consistently resolve the condition, indicating the need for multifaceted approaches.
- Adverse events associated with flibanserin include dizziness, somnolence, hypotension, syncope, and sedation-related events, which have a similar incidence rate as other serotonergic medications, but its contraindication with alcohol requires particular attention.
- Flibanserin is specifically indicated for premenopausal women with HSDD within the broader category of FSD sufferers. Its effectiveness varies based on demographic and baseline characteristics, necessitating cautious use, especially regarding alcohol consumption.
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 |
---|---|---|
Treatments for postmenopausal hypoactive sexual desire disorder. | 2020 | American Family Physician |
Female hypoactive sexual desire disorder: a practical guide to causes, clinical diagnosis, and treatment. | 2020 | Journal of Women’s Health |
Management of hypoactive sexual desire disorder in transgender women: a guide for clinicians. | 2020 | International Journal of Impotence Research |
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 |