Alongside its targeted effects on postsynaptic serotonin receptors, flibanserin exhibits limited antagonistic activity on 5-HT2B, 5-HT2C, and DA D4 receptors.

Take-Home Points

This makes flibanserin a pivotal choice for premenopausal women experiencing primary HSDD. This activity covers flibanserin's indications, contraindications, mechanism of action, administration, monitoring, and toxicity. This activity aims to enhance collaboration among healthcare professionals for improved management of HSDD in patients using flibanserin, ultimately leading to more effective patient care and superior outcomes. Identify the specific indications for flibanserin use in premenopausal women with hypoactive sexual desire disorder, distinguishing it from other therapeutic options. Assess patients for potential contraindications and monitor for adverse effects, ensuring ongoing assessment of the medication's impact on sexual function and overall well-being.

Postmarketing Reports

Apply knowledge of flibanserin's mechanism of action into clinical decision-making, aligning its pharmacological effects with patient-specific factors. Collaborate with other healthcare professionals to enhance interdisciplinary approaches in managing hypoactive sexual desire disorder, fostering comprehensive and patient-centered care. Sexual dysfunction affects approximately 50% of women in the United States. Among the various factors contributing to sexual dysfunction in women, hypoactive sexual desire disorder (HSDD) is the most commonly identified cause. [1][2] The diagnosis of this condition is unrelated to relationship issues, psychiatric or medical conditions, or the effects of medication or drugs.

Ask her, and start the conversation.

Although the exact physiological causes of HSDD remain inconclusive, a hypothesis suggests that HSDD may be influenced by neurotransmitter function and hormonal levels. Flibanserin is the first medication approved by the U.S. Food and Drug Administration (FDA) in 2015 for the management of HSDD in premenopausal women. [3] The American College of Obstetricians and Gynecologists (ACOG) supports the use of flibanserin for premenopausal women experiencing HSDD. [4] The American Psychiatric Association's guidelines also acknowledge flibanserin as a viable treatment option for HSDD. [3][11] Flibanserin is not associated with addiction or misuse potential, as it does not alter dopaminergic neurotransmission in the nucleus accumbens.

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Absorption: In healthy premenopausal women, the oral administration of a 100 mg dose of flibanserin results in a time to reach a maximum plasma concentration of approximately 0.75 hours.

Results In As Little As 4 Weeks

Your online visit today is only $49 $19. By clicking here you will go to a third-party telemedicine provider. See full prescribing Information including Boxed Warning regarding severe low blood pressure and fainting in certain settings at addyi.com/pi Your online visit today is only $49 $19. What is the most important information I should know about ADDYI? ADDYI can cause severe low blood pressure and fainting (loss of consciousness).

Approval Year

Your risk is higher if you drink alcohol close to your dose. Do not take ADDYI with certain medicines or if you have liver problems. To lower your risk of low blood pressure and fainting: Do not drink alcohol close to the time you take ADDYI. Skip your dose if you had 3 or more drinks before bedtime. Wait at least 2 hours after 1–2 alcoholic drinks before taking ADDYI.

Are you currently using Addyi (flibanserin)?

After taking ADDYI, do not drink alcohol until the next day Talk to your doctor about the medicines and supplements you take and before starting any new ones Do not take ADDYI if you have liver problems If you feel dizzy or lightheaded after taking ADDYI, lie down right away. Get medical help if symptoms do not go away. take certain medicines that increase ADDYI levels in your blood (including some treatments for HIV, fungal infections, antibiotics, hepatitis C, heart conditions, or depression such as nefazodone) What should I tell my doctor before taking ADDYI? Tell your doctor about all your medical conditions, including if you: drink alcohol, use drugs, or have a history of substance abuse have ever had depression or other mental health conditions have low blood pressure or a condition that can cause it Tell your doctor or pharmacist about all medicines and supplements you take, as they may interact with ADDYI. What should I avoid while taking ADDYI? The absolute bioavailability of flibanserin after oral dosing is 33%. Distribution: Flibanserin binds primarily to albumin, exhibiting a plasma protein binding of approximately 98%.

Bottom Line

Although flibanserin was initially developed to treat depression, studies revealed its ineffectiveness as an antidepressant compared to a placebo. However, these initial studies did identify positive results in terms of sexual function. [6] Subsequently, the effectiveness of flibanserin was analyzed through several clinical trials—3 of which involved premenopausal women who had experienced HSDD for a minimum of 6 months. The participants in the study had a mean age of 36, a relationship duration of 11 years, and an HSDD duration of 5 years. Clinical trial results demonstrated statistical significance in endpoint measurements, utilizing the Female Sexual Function Index (FSFI) and satisfying sexual events (SSE).

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The FSFI addressed the following 2 questions: "Over the past 4 weeks, how often did you feel sexual desire or interest?" "Over the past 4 weeks, how would you rate your level of sexual desire or interest?" Furthermore, patient responses to the statement, "Indicate your most intense level of sexual desire." For both endpoint measurements, values were calculated on a scale of 1 to 5 (ranging from almost never or never to almost always or always) or 0 to 3 (ranging from no desire to strong desire). All 3 clinical trials included an additional endpoint assessing, "How often did you feel bothered by low sexual desire?" on a scale of 0 to 4 (ranging from never to always) over 7 days. The results of this endpoint were comparable to that of the FSFI score, suggesting improvement in sexual satisfaction. The mean change from baseline at week 24 was approximately 0.7 for FSFI and -0.7 for the additional endpoint. [9][10] Serotonin influences various tadalista professional physiological functions, including sexual desire.

Comparison table

The negative regulation of libido occurs through microcircuits at sites where serotonin and prolactin exert their actions. This suggests that an imbalance in these microcircuits may contribute to the development of HSDD, indicating reduced levels of DA and NE and increased amounts of 5-HT. Flibanserin selectively targets central serotonin postsynaptic receptors, exhibiting both agonistic and antagonistic effects on 5-HT1A and 5-HT2A, respectively. Flibanserin's activity on these specific serotonin receptors distinguishes it from other drugs targeting serotonin receptors. The activity of flibanserin on 5-HT1A and 5-HT2A receptors leads to elevated NE and DA levels and reduced serotonin levels within the prefrontal cortex intracellularly. Metabolism: Flibanserin undergoes primary metabolism through the cytochrome P450 enzymes CYP3A4 and CYP2C19,[12] with minimal contributions to its metabolism made from CYP1A2, CYP2B6, CYP2C8, CYP2C9, and CYP2D6 based on in vitro and in vivo data.

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

Flibanserin undergoes extensive metabolism, resulting in at least 35 metabolites, most of which are present in low concentrations in plasma. Among these, only 2 metabolites—6,21-dihydroxy-flibanserin-6,21-disulfate and 6-hydroxy-flibanserin-6-sulfate—exhibit plasma concentrations comparable to flibanserin.

• Flibanserin's prescribing information highlights the risk of severe hypotension.
• The drug’s efficacy is evaluated via sexual desire and satisfaction questionnaires.
• It is meant to be part of a comprehensive approach to female sexual dysfunction.
• Some women report improved libido and satisfaction after consistent use.
• Flibanserin can impair alertness, affecting daily activities.
• Medical professionals should counsel patients thoroughly before initiating therapy.
• The medication is not recommended in women with certain pre-existing health conditions.
• Insurance approval may require documentation of HSDD diagnosis.
• Long-term use data for flibanserin is limited, and ongoing studies are necessary.

Notably, both of these metabolites are inactive.

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

The average terminal half-life of flibanserin is approximately 11 hours.

• 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.

Flibanserin is available in a 100 mg oral tablet form and is administered once daily at bedtime.

Proper Use

Do not drink alcohol close to your dose Do not drive or operate machinery for at least 6 hours after taking ADDYI Do not take supplements such as St. John’s Wort, ginkgo, or resveratrol, or certain medicines like cimetidine, without talking to your doctor What are the possible side effects of ADDYI? ADDYI can cause serious side effects, including: See “What is the most important information I should know about ADDYI?” This is not a complete list of side effects. ADDYI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women < 65 years of age who have not had problems with low sexual desire in the past, no matter the type of sexual activity, situation, or sexual partner, and it is troubling to them. Their low sexual desire is not due to a medical or mental health problem, problems in the relationship, medicine or other delayed ejaculation pills drug use.

Interaction with Alcohol

ADDYI is not for use in men or to improve sexual performance. This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal. A service of the National Library of Medicine, National Institutes of Health. Treasure Island (FL): StatPearls Publishing; 2026 Jan-.

Other Medical Problems

Flibanserin, initially developed as an antidepressant, is the first medication approved by the U.S. Food and Drug Administration (FDA) for the management of hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by limited or absent sexual fantasies or desires, resulting in interpersonal strain or heightened distress, which persist for a minimum of 6 months. Flibanserin is specifically indicated for patients whose diagnosis is unrelated to relationship issues, psychiatric or medical conditions, or the effects of medication or drugs. Recent trials involving premenopausal women who have endured HSDD for a minimum of 6 months have further reinforced the drug's potential as a practical therapeutic option. Flibanserin is recommended to be taken at bedtime to minimize the risk of hypotension, syncope, accidental injury, or central nervous system (CNS) depression during waking hours.

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