Veterans Health Library

Due to the limited sample size in moderate hepatic impairment (Child-Pugh score of 8 to 9 points), conclusive statements regarding the impact of flibanserin exposure cannot be asserted.

• In 2019, the FDA required updates to the prescribing information regarding liver injury.
• Cases of hepatitis and liver enzyme elevations were reported post-marketing.
• Patients should be monitored for symptoms of liver injury (jaundice, dark urine).
• Discontinue flibanserin if liver injury is suspected.
• The REMS was modified to strengthen the warning about hepatotoxicity.
• Patients with signs of liver disease should not start flibanserin.
• Baseline liver enzyme testing is now considered a standard part of patient assessment.
• Follow-up testing may be recommended based on clinical judgment.
• The overall incidence of serious liver injury appears to be low.

Notably, flibanserin is contraindicated for hepatic impairment. Renal impairment: The pharmacokinetic data in the labeling indicates a slight increase in the area under the curve (AUC) by 1.1-fold in mild-to-moderate renal impairment and a 1.2-fold increase in AUC for severe renal impairment compared to healthy individuals. In addition, the data suggest that patients with renal impairment may not require dosage adjustments, as the observed alteration in AUC is minimal. The FDA-approved labeling does not specify any dosage adjustments for renal impairment.

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

Pregnancy considerations: An ongoing flibanserin pregnancy registry study assesses pregnancy outcomes in women exposed to flibanserin at any stage of pregnancy ( To date, no studies on pregnant women have conclusively identified any drug-associated risks.

How much does Addyi (flibanserin) cost?

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 physiological functions, including sexual desire. The negative regulation of libido occurs through microcircuits at sites where serotonin and prolactin exert their actions. This suggests that buy cenforce pills 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.

Does Addyi interact with foods or drinks?

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. Alongside its targeted effects on postsynaptic serotonin receptors, flibanserin exhibits limited antagonistic activity on 5-HT2B, 5-HT2C, and DA D4 receptors. [3][11] Flibanserin is not associated with addiction or misuse potential, as it does not alter dopaminergic neurotransmission in the nucleus accumbens. 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.

Pregnancy Categories

The absolute bioavailability of flibanserin after oral dosing is 33%. Distribution: Flibanserin binds primarily to albumin, exhibiting a plasma protein binding of approximately 98%. 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 ed gel CYP2D6 based on in vitro and in vivo data. 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. However, studies based on animals have indicated certain adverse effects on reproduction and development, including diminished fetal weight, structural anomalies, and increased fetal loss, sex tablet for women observed at exposures significantly exceeding the maximum recommended human dosage. Notably, although flibanserin is not recommended during pregnancy, it is also not contraindicated in this population.

• 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.

Breastfeeding considerations: Although flibanserin has been detected in rat milk, its presence in human milk and its impact on the breastfed infant and milk production remains unknown.

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

Due to the potential for adverse reactions, including sedation in a breastfed infant, breastfeeding is not recommended during flibanserin treatment. Pediatric patients: Flibanserin is not approved by the FDA for use in the pediatric population.

• 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.

Older patients: Flibanserin lacks FDA approval for use in older individuals, as its safety and efficacy in this age group have not been confirmed. The most frequently reported adverse effects of flibanserin, with an incidence of over 2%, include dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth, listed in descending order of frequency.

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[15][14] Hypotension and syncope may manifest if flibanserin is combined with moderate or potent CYP3A4 inhibitors in individuals with hepatic impairment, alcohol, or other medications known for inducing hypotension and syncope. Less frequently reported adverse effects in clinical trials include anxiety, constipation, abdominal pain, sedation, accidental injury, appendicitis, and vertigo.

Microcircuits and Sexual Interest and Desire

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. 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.

What are some things I need to know or do while I take this drug?

[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. 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.

Interaction with Alcohol

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). 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. CNS depressants: CNS depressants, such as diphenhydramine, opioids, hypnotics, and benzodiazepines, pose an elevated risk of CNS depression when used concurrently with flibanserin compared to the use of flibanserin alone.

Risks and warnings for Addyi (flibanserin)

[14] However, in 2019, the FDA replaced the original REMS with a medication-guide-only REMS, eliminating the certification requirement for prescribers or pharmacists. Pharmacogenetics: Clinicians should be mindful of pharmacogenetic variations to mitigate the risk of adverse effects related to flibanserin, particularly in patients identified as poor CYP2C19 metabolizers. Individuals classified as poor CYP2C19 metabolizers may experience elevated levels of flibanserin, heightening the risk of adverse events such as hypotension, syncope, and CNS depression. This subgroup constitutes 2% to 5% of Caucasians and Africans and 2% to 15% of Asians. Hepatic impairment: Mild hepatic impairment (Child-Pugh score of 5 to 6 points) showed that single 50 mg oral doses of flibanserin led to increased systemic exposure and a longer half-life than those with normal hepatic function. Healthcare professionals should engage in a comprehensive discussion with the patient regarding the concomitant use of other CNS depressants when prescribing flibanserin, considering the potential risks and benefits.

Side effects

Notably, both of these metabolites are inactive. The average terminal half-life of flibanserin is approximately 11 hours. Flibanserin is available in a 100 mg oral tablet form and is administered once daily at bedtime. 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. In case of a missed dose, patients are recommended to take it the following night without doubling the dosage.

Advocacy groups

If the patient does not report any improvement in their symptoms after 8 weeks of compliance with the medication, flibanserin should be discontinued. Healthcare professionals should carefully consider concomitant medications outlined in the drug interactions. Healthcare providers should exercise caution when prescribing flibanserin in conjunction with potent CYP2C19 inhibitors. The combination of these medications has been associated with heightened adverse reactions, likely stemming from presumed elevated levels of flibanserin. Upon its approval in August 2015, flibanserin required a Risk Evaluation and Mitigation Strategy (REMS) program that included Elements to Assure Safe Use (ETASU), which mandated certification for both prescribers and pharmacists. The coadministration of flibanserin with alcohol is addressed explicitly in box warnings.

• The chemical name is 1,2,3,4-tetrahydro-1-{[2-(1,2,3,4-tetrahydro-8-quinolyl)ethyl]amino}methyl-6-fluorobenz[cd]indol-5(6H)-one.
• Molecular formula is C₂₀H₂₁F₃N₄O.
• It is a white to off-white powder that is slightly soluble in water.
• The tablet contains inactive ingredients: microcrystalline cellulose, croscarmellose sodium.
• Also contains magnesium stearate, hypromellose, titanium dioxide, and iron oxide red.
• Manufactured under strict Good Manufacturing Practice (GMP) standards.
• Distributed in bottles or blister packs, typically containing 30 tablets.
• National Drug Code (NDC) for Addyi 100 mg is 0187-XXXX-XX (varies by pack).
• Keep out of reach of children and pets.

Strong or moderate CYP3A4 inhibitors: Strong or moderate CYP3A4 inhibitors, including azole antifungals and protease inhibitors, warrant careful consideration in assessing a patient's current medication regimen.