Let's Talk About Sex
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
| 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 |
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.
WHY is this medicine prescribed?
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.
Approval process and advocacy
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.
Pregnancy Categories
In best erection pills 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 United States Food and Drug Administration (FDA) approved the drug flibanserin (sold under the brand
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name Addyi) for the treatment of women with hypo-active sexual desire disorder (HSDD) in August 2015.
Addyi (flibanserin) contraindications
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. Australia hasn’t followed suit, though flibanserin is available through internet pharmacies.
What does it ‘treat’?
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 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. However, its limited effectiveness and serious side-effects should cause potential users to rethink purchasing flibanserin online.
- 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.
Hypo-active sexual desire disorder HSDD was listed in the DSM-4, the previous edition of the Diagnostic and Statistical Manual of Mental Disorders.
Risks and warnings for Addyi (flibanserin)
The agency's approach aims to ensure that patients and prescribers know about the risks so they can make informed decisions about using flibanserin. Because HSDD is symptomatic, patients can directly assess whether any improvements they experience are worth the risks. Flibanserin should be discontinued if HSDD symptoms do not improve after 8 weeks of treatment. It's impossible to know any drug's full safety profile at the time of approval. Beyond the safety measures noted above, the FDA is requiring three postapproval trials to further elucidate the alcohol interaction in women, plus enhanced pharmacovigilance for hypotension, syncope, accidental injury, and death.
Does Addyi interact with foods or drinks?
The agency will be able to take regulatory action as needed on the basis of the resulting data. We believe this is a reasonable approach that balances safety and access. Although the FDA does not regulate off-label use, we encourage responsible prescribing and emphasize that the approval is only for the population that was studied — premenopausal women with HSDD. This article was published on December 9, 2015, at NEJM.org. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
What should I do if I accidentally use too much Addyi?
Patient-focused drug development public meeting and scientific workshop on female sexual dysfunction, 2014 ( Transcript for the June 18, 2010, meeting of the Advisory Committee for Reproductive Health Drugs ( Nguyen, CP, Hirsch, MS, Moeny, D, Kaul, S, Mohamoud, M, Joffe, HV. Testosterone and “age-related hypogonadism” -- FDA concerns. N Engl J Med 2015;373:689-691 Results from the 2013 National Survey on Drug Use and Health: summary of national findings. Rockville, MD: Substance Abuse and Mental Health Administration, 2014 ( Addyi tablets (FDA staff reviews, REMS, labels and action letters). Any commercial reuse of NEJM Group content requires permission. The disorder relates to persistently deficient (or absent) sexual fantasies and desire for sexual activity, which causes marked distress and relationship problems.
Adverse Effects
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).
Addyi affects
Genitourinary Symptoms of Menopause in Patients with Serious Illness #511, Journal of Palliative Medicine, cenforce 200mg canada 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).
Storage Requirements
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 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 . 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.
- Global availability varies; approved in the US, Canada, and some other countries.
- Not approved in the European Union by the EMA as of current knowledge.
- Different brand names may be used in countries where it is marketed.
- Importing for personal use from other countries carries risks and is often illegal.
- Counterfeit versions of the medication are a potential danger.
- Patients should only obtain it from a certified, licensed pharmacy.
- Telemedicine may be used for consultations but REMS requirements still apply.
- The future of flibanserin may involve generic competition reducing cost.
- Research into its potential effects on other conditions (e.g., depression) is limited.
Others suggest up to 43% of women may experience low sexual desire.
- Flibanserin is used to treat premenopausal women with hypoactive sexual desire disorder (HSDD).
- It is marketed under the brand name Addyi.
- Flibanserin works by modulating serotonin and dopamine levels in the brain.
- It was approved by the FDA in 2015 for HSDD treatment.
- Common side effects include dizziness, nausea, and fatigue.
- Flibanserin is usually taken once daily at bedtime.
- It has contraindications with alcohol due to risk of severe hypotension.
- Patients should avoid alcohol while using flibanserin.
- It is a non-hormonal medication specifically for sexual desire issues.
However, there is fierce debate about the definition of disorders of sexual desire, with HSDD described as a “highly controversial diagnostic construct”.
| 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 |
