US Food and Drug Administration Approval of Addyi (Flibanserin) for Treatment of Hypoactive Sexual Desire Disorder

The newer DSM-5, published in May 2013, combined features of HSDD and another condition known as female sexual arousal disorder, to form a new condition, female sexual interest/arousal disorder (FSIAD).

This has stricter diagnostic criteria and as yet unknown prevalence. Originally trialled as an antidepressant, flibanserin found new life as a treatment for low sexual desire in women.

After being rejected for approval by the FDA in 2010, developers Boehringer Ingelheim transferred the rights to Sprout Pharmaceuticals, which finally and controversially secured FDA approval in August 2015.

• 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.

Flibanserin modulates neurotransmitters in the brain, increasing levels of dopamine and norepinephrine and decreasing serotonin.

• Flibanserin was developed by Boehringer Ingelheim, later licensed to Sprout Pharmaceuticals.
• It is considered a "female Viagra," though its mechanism differs from male erectile drugs.
• The medication is part of the growing field of female sexual dysfunction treatment.
• Most clinical trials showed a modest increase in satisfying sexual events.
• Flibanserin should be taken consistently for best results.
• It is not recommended for women who are pregnant or breastfeeding.
• Common adverse reactions include dry mouth and insomnia.
• The drug was approved after extensive clinical trials involving thousands of women.
• Long-term safety data is still being collected.

As dopamine and norepinephrine promote sexual arousal, and serotonin reduces sexual arousal, flibanserin may increase libido by improving the balance between these neurotransmitter systems.

Addyi is the #1 Prescribed Treatment by doctors for HSDD.1

Published ahead of print: December 9, 2015 From the Food and Drug Administration, Silver Spring, MD. Select the format you want to export the citation of this publication. Management of sexual dysfunction in menopause: an update on evidence-based strategies, Expert Review of Endocrinology & Metabolism, 21, 1, (13-27), (2025). Impact of Hypoactive Sexual Desire Disorders on Mental Well-Being and Daily Activities: Pharmacological Therapy?, Hypoactive Sexual Desire Disorder, (55-63), (2025). Practical considerations and emerging approaches for the management of vasomotor and sexual symptoms in breast cancer patients on endocrine therapies, Expert Review of Clinical Pharmacology, 18, 10, (739-751), (2025).

Hepatic Impairment

Genitourinary Symptoms of Menopause in Patients with Serious Illness #511, Journal of Palliative Medicine, 28, 10, (1409-1411), (2025). Single-nucleus RNA sequencing reveals cellular and molecular signatures in the prefrontal cortex of a hypoactive sexual desire disorder rat model, The Journal of Sexual Medicine, 22, 11, (1911-1922), (2025). Advancing Women’s Health: A Scoping Review of Pharmaceutical Therapies for Female Sexual Dysfunction, Sexes, 6, 3, (38), (2025). Enhancing Sexual Health for Cancer Survivors, American Society of Clinical Oncology Educational Book, 45, 3, (2025). Sexual health in cancer care: a narrative review and position statement from the Italian Association of Medical Oncology (AIOM), ESMO Open, 10, 6, (105311), (2025). The US FDA approval process was mired in controversy, particularly in relation to the active role of Sprout Pharmaceuticals in lobbying.

It funded a high-profile public advocacy campaign called Even the Score, which misleadingly claimed the drug was initially rejected because of FDA sexism.

Reward Processing as a Symptom Dimension in Psychiatric Disorders

Recommended dosage is 100 mg taken once daily at bedtime, discontinue treatment after 8 weeks if no improvement Curator's Comment: Flibanserin behaves as a 5-HT1A agonist in the cortex and hippo-campus of human and rat brain The concentration that reduces forskolin-induced cAMP formation by 50% in human hippocampus tissue was 4 nM. The United States Food and Drug Administration (FDA) approved the drug flibanserin (sold under the brand name Addyi) for the treatment of women with hypo-active sexual desire disorder (HSDD) in August 2015. Australia hasn’t followed suit, though flibanserin is available through internet pharmacies. However, its limited effectiveness and serious side-effects should cause potential users to rethink purchasing flibanserin online. Hypo-active sexual desire disorder HSDD was listed in the DSM-4, the previous edition of the Diagnostic and Statistical Manual of Mental Disorders.

Advocacy groups

The disorder relates to persistently deficient (or absent) sexual fantasies and desire for sexual activity, which causes marked distress and relationship problems. For a diagnosis, HSDD could not be due to the physiological effects of a substance or a general medical condition. Estimates of the prevalence of sexual desire problems vary widely depending on the criteria used – from 3% to 31% in one study. Others suggest up to 43% of women may experience low sexual desire. However, there is fierce debate about the definition of disorders of sexual desire, with HSDD described as vardenafil best price a “highly controversial diagnostic construct”. Despite counter campaigns by scientists and doctors, the FDA scientific advisory committee voted 18 to six in favour of approving the drug, with the condition that risk-management options were put in place.

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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. Curator's Comment: Description was created based on several sources, including Flibanserin is the first drug to be approved for hypoactive sexual desire disorder (HSDD) in premenopausal women by the FDA in August 2015. It was originally developed as an antidepressant medication by Boehringer Ingelheim, but showed lack of efficacy vardenafil pills in trials and was further developed as a hypoactive sexual disorder drug by Sprout Pharmaceuticals. Flibanserin's mechanism of action is attributed to its high affinity for 5-HTA1 and 5-HTA2 receptors, displaying agonist activity on 5-HTA1 and antagonist on 5-HTA2, resulting in lowering of serotonin in the brain as well as an effect on increasing norepinephrine and dopamine neurotransmitters. Flibansetrin has high affinity for serotonin receptors in the brain: it acts as an agonist on 5-HT1A and an antagonist on 5-HT2A.

Other Medical Problems

In vivo, flibanserin binds equally to 5-HT1A and 5-HT2A receptors. However, under higher levels of brain 5-HT (i.e., under stress), flibanserin may occupy 5-HT2A receptors in higher proportion than 5-HT(1A) receptors. It may also moderately antagonize D4 (dopamine) receptors and 5-HT2B and 5-HTB2C. Its action on neurotransmitter receptors may contribute to reduction in serotonin levels and increase in dopamine and norepinephrine levels, all of which may play part in reward processing. Flibanserin is sold under the trade name Addyi and 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. The committee members were concerned the drug had significant risks from side-effects, particularly if used off label or taken in combination with alcohol, and few benefits.

What does it ‘treat’?

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: normal menstrual bleeding occurring earlier, possibly lasting longer than expected Other side effects not listed may also occur in some patients. Drug class: miscellaneous central nervous system agents Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The only FDA-approved pill proven safe and effective for Hypoactive Sexual Desire Disorder (HSDD) in BOTH premenopausal and postmenopausal women (<65). 70% of women want you to start the convo about sexual health.2 70% of women want you to start the convo about sexual health.2 The exact mechanism of action of Addyi is unknown. I testified at the FDA 10 years ago when Addyi was approved — a watershed moment that validated women’s sexual health with the first FDA approved option to treat women with frustrating low libido.

renal dosing

In my practice, it opened conversations that had long been silenced and gave patients hope. “Addyi has helped me get my libido back. My sweet husband has been so patient with me for years now – I dreaded his advances – I can’t tell you how wonderful it has been to want sex again.” “When I heard about Addyi, I was curious if it would work for me. After only a few weeks on Addyi I’m already thinking about and wanting sex again!” “I used to dread going to bed with my husband, because I was never in the mood… he thought it was his fault. IQVIA Monthly Total Prescriptions Volume Data in the US. The committee’s recommendation that the drug be approved therefore attracted widespread criticism that it allowed politics to trump clinical science.

IMPORTANT WARNING:

Addressing Sexual Health in Breast Cancer Survivors: Evidence-Based Practices and Clinical Considerations, Current Treatment Options in Oncology, 26, 6, (476-485), (2025). Female Sexual Dysfunctions and Reproductive tadalis oral jelly Psychiatry, Textbook of Women’s Reproductive Mental Health, (67-92), (2024). Generic name: flibanserin [ flib-AN-ser-in ] Brand name: Addyi Drug class: Miscellaneous central nervous system agents The use of flibanserin and alcohol together close in time increases the risk of severe hypotension and syncope. Counsel patients to wait at least 2 hours after consuming 1 or 2 standard alcoholic drinks before taking flibanserin at bedtime or to skip their bedtime flibanserin dose if they have consumed 3 or more standard alcoholic drinks that evening. Flibanserin is contraindicated with moderate or strong CYP3A4 inhibitors and in patients with hepatic impairment due to risk of severe hypotension and syncope .

Consumer Information Use and Disclaimer

Flibanserin is used to treat hypoactive sexual desire disorder (HSDD) in women who have not gone through menopause. This medicine should only be used by women who have low sexual desire that is troubling to them and is caused by a medical or mental problem, problems in the relationship, or medicine or other drug use. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Make sure you tell your doctor if you have any other medical problems, especially: Depression or mental illness, history of or Drug or alcohol abuse, or history of or Hypotension (low blood pressure)—Use with caution. Within hours of the FDA approval, Sprout Pharmaceuticals was acquired by Valeant for $US1 billion.