FDA approves expanded use of flibanserin for hypoactive sexual desire disorder in women

Tell your doctor or pharmacist about the allergy and what symptoms you had. the following nonprescription or herbal products may interact with flibanserin: gingko; resveratrol; St.

Interaction Partner	Effect	Advice
Alcohol	Increased sedation and hypotension	Avoid concurrent use
CYP3A4 inhibitors	Elevated flibanserin levels	Dose adjustment or avoid
Other serotonergic agents	Increased risk of serotonin syndrome	Avoid concomitant use

John's wort; or medications for heartburn or indigestion such as cimetidine, esomeprazole, lansoprazole, omeprazole, or ranitidine. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking flibanserin. Do not start any of these medications while taking flibanserin without discussing with your healthcare provider. tell your doctor if you use drugs or have a history of drug abuse, or if you have or have ever had depression or other mental health problems. tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking flibanserin, call your doctor. you should know that flibanserin may make you drowsy.

Disorder of Sexual Interest and Desire, or of Arousal?

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. "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.

What are some side effects that I need to call my doctor about right away?

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. 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.

What are the most common side effects of Addyi?

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. Their low sexual desire is not due to: a medical or mental health problem, problems in the relationship or medicine or other drug use. Do not drive a car or operate machinery until at least 6 hours after your dose of flibanserin and until you know how this medication affects you.

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Do not eat grapefruit or drink grapefruit juice while taking this medication. Eating grapefruit or drinking grapefruit juice can increase the risk of having very low blood pressure. If you miss a dose at bedtime, skip the missed dose and take the next dose at bedtime the next day Do not take a double dose to make up for a missed one. hives; itching; hoarseness; difficulty breathing or swallowing; or swelling of the face, lips, or mouth Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Keep this medication in the container it came in, tightly closed, and out of reach of children.

Proper Use

Tell your doctor or pharmacist about the allergy and what symptoms you had. the following nonprescription or herbal products may interact with flibanserin: gingko; resveratrol; St. John's wort; or medications for heartburn or indigestion such as cimetidine, esomeprazole, lansoprazole, omeprazole, or ranitidine. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking flibanserin. Do not start any of these medications while taking flibanserin without discussing with your healthcare provider.

IN CLINICAL TRIALS1, WOMEN ON ADDYI EXPERIENCED:

tell your doctor if you use drugs or have a history of drug abuse, or if you have or have ever had depression or other mental health problems. tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking flibanserin, call your doctor. you should know that flibanserin may make you drowsy. Do not drive a car or operate machinery until at least 6 hours after your dose of flibanserin and until you know how this medication affects you.

Contact Us

Do not eat grapefruit or drink grapefruit juice while taking this medication. Eating grapefruit or drinking grapefruit juice can increase the risk of having very low blood pressure. If you miss a dose at bedtime, skip the missed dose and take the next dose at bedtime the next day Do not take a double dose to make up for a missed one. hives; itching; hoarseness; difficulty breathing or swallowing; or swelling of the face, lips, or mouth Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website for more information. In case of overdose, call the poison control helpline at 1-800-222-1222.

What SIDE EFFECTS can this medicine cause?

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 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. 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. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital.

Addyi (flibanserin) contraindications

You should carry the list with you in lovegra woman case of emergencies.

Metrics & Citations

Flibanserin (Addyi) is labeled for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is a nonhormonal medication that affects serotonin receptors to increase libido.1 The main risks of flibanserin are hypotension (2%) and syncope (0.4%), which are more likely to occur in patients who have also ingested alcohol. For this reason, women should not drink alcohol when taking flibanserin; about one in six persons taking this combination will experience clinically significant hypotension and syncope.1 Flibanserin should not be taken by women with hepatic impairment or women who are also taking moderate or strong cytochrome P450 3A4 inhibitors such as azole antifungals or protease inhibitors, which may increase serum levels.2 Flibanserin should be taken at night because adverse effects are more prominent when it is taken in the morning. Pregnancy and breastfeeding should be avoided while taking flibanserin, because its effects on humans are not known.2 Dizziness (11.4%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (2.4%) are reported with flibanserin but are less common when it is taken at bedtime. About one in eight patients will discontinue treatment because of adverse effects.1 Flibanserin has been evaluated in three randomized, double-blind, placebo-controlled studies of 2,375 premenopausal women with acquired, generalized HSDD, defined as low sexual desire causing marked distress or interpersonal difficulties.2 Women in monogamous, heterosexual relationships with no known cause of HSDD reported an average increase of 1.6 to 2.5 additional satisfying sexual events per month with treatment, from a baseline of 2.5 to 3.0 per month.

Common Adverse Effects

In comparison, women in the placebo group had an increase of 0.8 to 1.5 additional events per month. However, women taking flibanserin typically did not notice an increase in the intensity or frequency of sexual desire. In two of the three studies, distress associated with low sexual desire was not significantly improved with treatment compared with placebo.1 The effects of flibanserin on quality of life or patient or partner satisfaction have not been studied. Flibanserin has not been studied in nonheterosexual women or in women who are not in stable relationships. A one-month supply of flibanserin (100 mg per day) costs approximately $830.

Brand Names: US

Flibanserin is taken once daily at night to lessen the likelihood of adverse effects. If not effective after eight weeks of treatment, the medication should be discontinued. Certification is required of physicians before prescribing, and prescriptions can only be dispensed by pharmacists who have completed this training as well.3 Although flibanserin results in a modest improvement in the number of satisfying sexual events (approximately one more per month vs. placebo), it does not improve other measures, is considerably expensive, and has significant adverse effects. 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 labeled for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is a nonhormonal medication that affects serotonin receptors to increase libido.1 The main risks of flibanserin are hypotension (2%) and syncope (0.4%), which are more likely to occur in patients who have also ingested alcohol. For this reason, women should not drink alcohol when taking flibanserin; about one in six persons taking this combination will experience clinically significant hypotension and syncope.1 Flibanserin should not be taken by women with hepatic impairment or women who are also taking moderate or strong cytochrome P450 3A4 inhibitors such as azole antifungals or protease inhibitors, which may increase serum levels.2 Flibanserin should be taken at night because adverse effects are more prominent when it is taken in the morning. Pregnancy and breastfeeding should be avoided while taking flibanserin, because its effects on humans are not known.2 Dizziness (11.4%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (2.4%) are reported with flibanserin but are less common when it is taken at bedtime. About one in eight patients will discontinue treatment because of adverse effects.1 Flibanserin has been evaluated in three randomized, double-blind, placebo-controlled studies of 2,375 premenopausal women with acquired, generalized HSDD, defined as low sexual desire causing marked distress or interpersonal difficulties.2 Women in monogamous, heterosexual relationships with no known cause of HSDD reported an average increase of 1.6 to 2.5 additional satisfying sexual events per month with treatment, from a baseline of 2.5 to 3.0 per month. In comparison, women in the placebo group had an increase of 0.8 to 1.5 additional events per month. However, women taking flibanserin typically did not notice an increase in the intensity or frequency of sexual desire. In two of the three studies, distress associated with low sexual desire was not significantly improved with treatment compared with placebo.1 The effects of flibanserin on quality of life or patient or partner satisfaction have not been studied. Flibanserin has not been studied in nonheterosexual women or in women who are not in stable relationships. A one-month supply of flibanserin (100 mg per day) costs approximately $830. Flibanserin is taken once daily at night to lessen the likelihood of adverse effects.

Issue	Description
Efficacy Debate	Some experts question the clinical significance of benefits
Side Effect Concerns	Risks of hypotension, syncope, and severe allergic reactions
Marketing & Approval Controversies	Criticism over FDA approval process and marketing practices
Post-Marketing Surveillance	Ongoing monitoring for rare adverse events

If not effective after eight weeks of treatment, the medication should be discontinued. Certification is required of physicians before prescribing, and prescriptions can only be dispensed by pharmacists who have completed this training as well.3 Although flibanserin results in a modest improvement in the number of satisfying sexual events (approximately one more per month vs. placebo), it does not improve other measures, is considerably expensive, and has significant adverse effects. 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.

Country	Approval Status	Year
United States	Approved	2015
Canada	Approved	2016
European Union	Pending/Under review	N/A
Australia	Not approved	N/A

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. "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. 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.

• 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.

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. 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.

dopamine, norepinephrine, and serotonin3

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. Dispose of unneeded medications in a way so that pets, children, and other people cannot take them.

Addyi (filbanserin)

Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website for more information. In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

A note about sex and gender

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in lovegra woman case of emergencies. Addyi is not 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.

• Reporting of adverse events is encouraged through the FDA MedWatch program.
• Healthcare providers should report syncope, severe hypotension, or liver injury.
• Post-marketing surveillance is critical for understanding rare, long-term risks.
• Drug utilization reviews track prescribing patterns and potential misuse.
• In case of suspected pregnancy, patients should contact their doctor immediately.
• Animal studies showed developmental toxicity at doses much higher than human dose.
• Lactation studies in animals showed excretion in milk; human data are lacking.
• Decision to breastfeed while on flibanserin requires weighing potential risks.
• The benefit for an individual patient must justify the potential risk to a fetus/infant.

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.