FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder
Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated. INDICATION ADDYI (flibanserin) is indicated for the treatment of women less than 65 years of age 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, The effects of a medication or other drug substance.
- Flibanserin was one of the first drugs approved specifically for female hypoactive sexual desire.
- The drug's mechanism is different from that of PDE5 inhibitors used in men.
- It can induce side effects like low blood pressure and syncope, requiring caution.
- Patients should be monitored regularly for adverse effects during therapy.
- Flibanserin's approval marked significant progress in women's sexual health.
- It should be used with caution in women on other serotonergic medications.
- The medication's safety profile is still under ongoing research.
- It is not indicated for women with a history of alcohol abuse.
- The benefits of flibanserin are generally seen as modest but meaningful for some women.
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner. ADDYI is not indicated best pill for ed to enhance sexual performance. Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors Known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported. Hypotension and Syncope Due to an Interaction with Alcohol: See Boxed Warning for risks associated with alcohol consumption.
| Property | Description | Status |
|---|---|---|
| Approved Uses | Hypoactive Sexual Desire Disorder (HSDD) in women | Yes |
| Mechanism of Action | Serotonin receptor modulator | Partial agonist & antagonist |
| FDA Approval Year | 2015 | |
| Common Brand Name | Addyi |
After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.
IN THEIR WORDS
Sexual desire and the Female Sexual Function Index (FSFI): a sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study.
How is this drug best taken?
Neural basis of hypoactive sexual desire disorder in women: an event-related fmri study. Holstege G. How the emotional motor system controls the pelvic organs. Attitudinal survey of women blue 100 pill living with low sexual desire. Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): Results from a randomized withdrawal trial. Hypotension and Syncope with CYP3A4 Inhibitors: See Boxed Warning and Contraindication about use with moderate or strong cytochrome P450 3A4.
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Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope.
Addyi is the #1 Prescribed Treatment for HSDD.1
Their low sexual desire is not due to: a medical or mental health problem, problems in the relationship or medicine or other drug use. Addyi is not for use for the treatment of HSDD in women who have gone through menopause or in men or children. Addyi is not cost of vardenafil for use to enhance sexual performance. “Addyi has impacted the way we approach women’s sexual health. Seeing my patients feel like themselves again has been incredibly rewarding.” “Addyi has impacted the way we approach women’s sexual health.
Brand Names: US
Seeing my patients feel like themselves again has been incredibly rewarding.” Women may experience results in as little as 4 weeks but set her expectations to give Addyi 2 months to experience full effects. Let her know she may begin to notice sexual fantasies returning, become more receptive to her partner, and even initiate sex herself.* *Not all women will experience similar improvement in their HSDD. Some women may see results in as early as 4 weeks. Addyi should be discontinued if there is no improvement after 8 weeks. “When I heard about Addyi, I was curious if it would work for me.
Administration Notes
After only a few weeks on Addyi I’m already thinking about and wanting sex again!” “Addyi has been an invaluable addition to my toolbox, becoming a crucial component in the comprehensive care of my female patients experiencing stress due to low libido.” “I used to dread going to bed with my husband, because I was never in the mood… he thought it was his fault. * Based on IQVIA data as of November 2024 * Based on IQVIA data as of November 2024 MEDICAL INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com MEDICAL INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. Ryan KL, Arbuckle-Bernstein V, Smith G, Phillips J. Let’s Talk About Sex: A Survey of Patients’ Preferences When Addressing Sexual Health Concerns in a Family Medicine Residency Program Office. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone and is exacerbated by other CNS depressants.
Side Effects of flibanserin
In addition, its approval process and the role of its manufacturer in that process have sparked controversy.4 Unless further studies demonstrate better safety and effectiveness, flibanserin is best reserved for a few select patients after more conservative options have been tried. Flibanserin (Addyi) is now approved for treating HSDD in postmenopausal women, expanding its previous indication for premenopausal women. The FDA's priority review designation for flibanserin underscores its potential to significantly improve treatment safety and effectiveness. With this approval, flibanserin becomes the first and only treatment of its kind for women younger than 65 years. On December 15, 2025, the FDA approved an expanded indication for flibanserin 100 mg (Addyi) for hypoactive sexual desire disorder (HSDD) in postmenopausal women younger than 65 years, Sprout Pharmaceuticals announced in a news release.1 Flibanserin was previously approved by the FDA in 2015 to treat HSDD in certain premenopausal women.2 Health Canada has also approved expanded use of the non-hormonal medication in women who have gone through menopause.
Does Addyi interact with foods or drinks?
"I was in the room a decade ago when Addyi became the historic first for women's sexual health, and I have been waiting for this moment ever since," said Rachel S. Rubin, MD, urologist and sexual medicine specialist, in the news release.1 "So many of my postmenopausal patients have carried the weight of frustrating low sexual desire with no FDA-approved option to turn to. It's a critical acknowledgment that their pleasure, their wellbeing, and their quality-of-life matter—and that science-backed care should be available to every woman, at every stage of her life." This approval follows the FDA’s priority review designation for flibanserin in July 2025. Priority review is granted to drugs that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” according to the FDA.3 With the approval today, flibanserin becomes the first and only treatment of its kind for women younger than 65 years, Sprout Pharmaceuticals noted. "This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized," said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals, in the news release.1 "Over the years, we've pushed for the science to speak louder than the stigma—and today's approval shows how far we've come.
Other Interactions
I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life." Historic First in Women's Sexual Health: FDA Grants Approval for Addyi® (flibanserin) in Postmenopausal Women. Sprout Pharmaceuticals receives FDA approval of Addyi (flibanserin 100 mg). The only FDA-approved pill proved safe and effective for Hypoactive Sexual Desire Disorder (HSDD) in certain premenopausal women. Addyi is for women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. The risk of CNS depression is also increased if ADDYI is taken during waking hours. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least six hours after each dose and until they know how ADDYI affects them.
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Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. Effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with hypoactive sexual desire disorder: A post hoc analysis. WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning. Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope. Hypotension and Syncope with ADDYI Alone: The use of ADDYI - without other concomitant medications known to cause hypotension or syncope - can cause hypotension and syncope. The risk is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken.
- Flibanserin's development was rooted in attempts to find antidepressants with sexual side effects.
- It was repurposed as a treatment for female sexual desire disorder.
- The medication is available by prescription only.
- It belongs to the class of serotonergic drugs affecting brain chemistry.
- Women with liver disease should avoid taking flibanserin.
- The medication is primarily metabolized in the liver via CYP3A4.
- Flibanserin has been the subject of debates over its cost-benefit ratio.
- It is not approved for use in men or non-binary individuals.
- Clinical guidelines recommend using flibanserin only after other causes of low desire are addressed.
Syncope and Hypotension in Patients with Hepatic Impairment: Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope. ADDYI is contraindicated in patients with hepatic impairment. Hypersensitivity Reactions: Reactions including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported with ADDYI.