Flibanserin

Flibanserin is not for use for the treatment of HSDD in women who have one through menopause or in men or children. Flibanserin is not for use to enhance sexual performance.

Product dosage: 100mg
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Synonyms Flibanserin Bimt-17 Bimt 17 Addyi

Flibanserin represents a significant pharmacological development in the treatment of premenopausal women diagnosed with acquired, generalized Hypoactive Sexual Desire Disorder (HSDD). As a multifunctional serotonin agonist and antagonist, it is the first FDA-approved medication of its kind specifically targeting the neurobiological pathways associated with low sexual desire. This product card provides a comprehensive, expert-level overview of its clinical profile, intended for healthcare professionals to facilitate informed prescribing decisions and patient counseling.

Features

• Active Pharmaceutical Ingredient: Flibanserin
• Pharmacologic Class: Multifunctional serotonin receptor agonist and antagonist
• Available Dosage Form: Oral tablet
• Standard Strength: 100 mg
• Mechanism of Action: Modulates neurotransmitter activity; decreases serotonin (5-HT1A receptor agonism and 5-HT2A receptor antagonism) while increasing dopamine and norepinephrine in key brain areas, rebalancing the excitatory/inhibitory pathways involved in sexual desire.

Benefits

• Provides a non-hormonal, centrally-acting pharmacological option for managing HSDD.
• Clinically demonstrated to increase the number of satisfying sexual events (SSEs).
• Shown to significantly reduce the distress associated with low sexual desire.
• Offers a targeted approach to a complex biopsychosocial condition.
• May restore a more natural balance of neurotransmitters involved in the sexual response circuit.

Common use

Flibanserin is indicated for the treatment of premenopausal women with acquired, generalized Hypoactive Sexual Desire Disorder (HSDD). Acquired HSDD refers to a condition that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to a condition that occurs regardless of the type of sexual activity, situation, or partner. It is critical that other potential causes of low libido (e.g., co-morbid medical or psychiatric conditions, relationship issues, or side effects of concomitant medications) are ruled out prior to diagnosis and treatment initiation.

Dosage and direction

• The recommended dosage is 100 mg taken orally once daily at bedtime.
• Administration at bedtime is recommended to mitigate the risk of adverse reactions such as hypotension, syncope, and central nervous system depression (e.g., somnolence, sedation).
• The medication can be taken with or without food; however, consistent administration relative to food may help manage variability in absorption.
• Efficacy should be re-evaluated after 8 weeks of treatment to determine if continued therapy is warranted.

Precautions

• Hypotension and Syncope: Flibanserin can cause severe hypotension and syncope. Risk is increased with concomitant alcohol use and with use of moderate or strong CYP3A4 inhibitors. Patients should be advised of the risk and the strict avoidance of alcohol.
• Central Nervous System Depression: Flibanserin can cause CNS depression (e.g., somnolence, sedation). Patients should not engage in potentially hazardous activities requiring complete alertness until at least 6 hours after taking the dose and they know how the drug affects them.
• Hepatic Impairment: Flibanserin is not recommended in patients with hepatic impairment.
• Pregnancy and Lactation: There are no adequate data on the developmental risk associated with use in pregnant women. Use during lactation is not recommended.

Contraindications

• Concomitant use with alcohol.
• Concomitant use with moderate or strong CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, erythromycin, verapamil, grapefruit juice).
• Patients with hepatic impairment.
• A history of hypersensitivity to flibanserin or any of its components.

Possible side effect

Common adverse reactions (incidence ≥2% and greater than placebo) include:

• Dizziness
• Somnolence (sleepiness)
• Nausea
• Fatigue
• Insomnia
• Dry mouth
• Other reported side effects can include anxiety, decreased blood pressure, and syncope (fainting).

Drug interaction

Flibanserin is primarily metabolized by CYP3A4 and, to a lesser extent, by CYP2C19. Its pharmacokinetic profile is highly susceptible to drug-drug interactions.

• Contraindicated Interactions: Alcohol and moderate/strong CYP3A4 inhibitors (see Contraindications).
• CYP2C19 Inhibitors: Concomitant use with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine) may increase flibanserin exposure. Consider alternative therapies.
• CYP3A4 Inducers: Concomitant use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort) may significantly decrease flibanserin exposure and reduce its efficacy. Avoid concomitant use.
• CNS Depressants: Concomitant use with other CNS depressants (e.g., benzodiazepines, narcotics, sleep aids) may potentiate sedation and somnolence. Use with caution.
• Digoxin: Flibanserin may increase digoxin concentrations. Monitor digoxin levels when initiating or discontinuing flibanserin.

Missed dose

If a dose is missed, it should be skipped. The patient should not take a double dose to make up for the missed dose. The next dose should be taken at the usual time the following bedtime.

Overdose

In cases of suspected overdose, symptomatic and supportive measures should be initiated. There is no specific antidote for flibanserin overdose. Given the drug’s primary effects, overdose is likely to manifest as an exaggeration of its known adverse effects, including severe hypotension, syncope, and profound CNS depression (sedation, somnolence). Vital signs should be monitored, and appropriate management for hypotension and sedation should be provided. Due to the high protein binding of flibanserin, dialysis is unlikely to be effective.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F).
• Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Keep in the original container to protect from light and moisture.
• Keep out of reach of children and pets.

Disclaimer

This information is intended for educational and informational purposes for healthcare professionals only and is not a substitute for professional medical advice, diagnosis, or treatment. It is derived from the manufacturer’s prescribing information but may not be exhaustive. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or a specific medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The prescriber holds the ultimate responsibility for verifying the latest prescribing information, evaluating the patient’s individual case, and making the final treatment decision.

Reviews

• “As a clinician specializing in women’s sexual health, flibanserin provides a valuable tool in our limited arsenal for HSDD. It is not a ‘female Viagra’ but a nuanced treatment that requires careful patient selection and extensive counseling on contraindications, especially alcohol avoidance. In the right patient population, the improvement in desire and, more importantly, the reduction of associated distress can be clinically meaningful.” – Sexual Health Specialist, MD
• “The clinical trial data supporting flibanserin demonstrates a statistically significant, though modest, increase in satisfying sexual events and a decrease in distress scores compared to placebo. The safety profile necessitates a strict Risk Evaluation and Mitigation Strategy (REMS) program. It is a medication that demands a strong therapeutic alliance and patient compliance for safe and effective use.” – Clinical Researcher, PhD
• “Managing patient expectations is paramount. This is not a quick fix. It requires daily dosing and time to assess effect. For my motivated patients who understand the risks and commit to the lifestyle modifications (no alcohol), it has been a beneficial part of a comprehensive treatment plan that often includes psychotherapy.” – Gynecologist, MD