Drug updated on 9/4/2024
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.
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Summary
- Addyi (flibanserin) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), 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.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- In premenopausal women with Hypoactive Sexual Desire Disorder (HSDD), flibanserin increased satisfying sexual events (SSEs) by 2.1 ± 0.14 over 28 days, compared to 1.2 ± 0.11 with placebo (p < 0.0001). Flibanserin also increased FSFI-d scores by 0.9 ± 0.04 versus 0.6 ± 0.04 with placebo (p < 0.0001) and decreased FSDS-R-13 scores by -0.9 ± 0.04 versus -0.6 ± 0.04 with placebo (p < 0.0001).
- Bremelanotide, while not directly compared numerically, was noted to improve desire, arousal, and orgasm scores in premenopausal women, suggesting a broader impact on sexual function than flibanserin, which primarily affects sexual desire and distress.
- Hormone therapy and testosterone showed effectiveness in improving sexual desire in menopausal women, but these were not directly comparable to flibanserin, which is indicated for premenopausal women with HSDD.
- The most common adverse events reported in premenopausal women with HSDD using flibanserin were dizziness and somnolence, occurring in ≥10% of patients, with additional concerns about hypotension, syncope, and sedation, particularly when combined with alcohol, as well as nausea, insomnia, and dry mouth.
- The safety profile of flibanserin includes similar incidences of hypotension, syncope, and sedation-related adverse events compared to serotonergic antidepressants, though these events occurred less frequently than with triptans. The risk of severe adverse events is notably increased with alcohol use, necessitating a boxed warning and contraindication.
- There is no population types or subgroups 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 |
---|---|---|
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 |