Drug updated on 5/17/2024

Dosage FormTablet (oral; 100 mg)
Drug ClassSexual Disorder Agents
Ongoing and
Completed Studies


  • 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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  • 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.