Flibanserin: A Medical Breakthrough for Hypoactive Sexual Desire Disorder
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Synonyms | |||
Flibanserin represents a significant advancement in the pharmacological management of acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. As a multifunctional serotonin agonist and antagonist, it operates centrally to rebalance neurotransmitter activity implicated in sexual motivation and response. This non-hormonal, daily oral treatment is the first FDA-approved medication of its kind, offering a targeted neurochemical approach for a complex and often distressing condition. Its approval marks a pivotal shift toward recognizing and medically addressing female sexual dysfunction with evidence-based intervention.
Features
- Active pharmaceutical ingredient: Flibanserin 100 mg
- Pharmacologic class: Multifunctional serotonin receptor agonist and antagonist
- Administration: Oral tablet, once daily at bedtime
- Mechanism of action: Modulates serotonin (5-HT1A agonist/5-HT2A antagonist), dopamine, and norepinephrine systems in brain regions governing sexual desire
- Prescription status: Schedule IV controlled substance, requiring REMS (Risk Evaluation and Mitigation Strategy) program
- Bioavailability: Approximately 33%, with peak plasma concentration reached in 0.75–1.5 hours
- Half-life: Approximately 11 hours
- Metabolism: Primarily hepatic, via CYP3A4 and CYP2C19 pathways
Benefits
- Increases the frequency of satisfying sexual events by addressing central neurochemical imbalances
- Enhances sexual desire and reduces associated distress in qualifying premenopausal women
- Provides a non-hormonal therapeutic option, avoiding systemic estrogen or testosterone exposure
- Improves overall sexual satisfaction and intimacy-related quality of life metrics
- Supported by robust clinical trial data demonstrating statistically significant efficacy over placebo
- Integrates into a holistic treatment plan that may include psychological or relationship counseling
Common use
Flibanserin is indicated for the treatment of premenopausal women with acquired, generalized Hypoactive Sexual Desire Disorder (HSDD), characterized by a persistent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty. It is not intended for use in postmenopausal women or men, nor for the treatment of sexual dysfunction due to co-existing medical or psychiatric conditions, relationship problems, or the effects of substance abuse. Diagnosis should adhere to DSM-5 criteria, and treatment should only be initiated after thorough clinical evaluation and exclusion of alternative etiologies.
Dosage and direction
The recommended dosage is 100 mg taken orally once daily, at bedtime. Administration at bedtime is advised to mitigate the risk of hypotension, syncope, and central nervous system depression. Tablets should be swallowed whole and may be taken with or without food, though consistency in timing is recommended. Dose escalation is not indicated; the 100 mg dose is the sole therapeutic strength. Treatment discontinuation should be considered after 8 weeks if no clinically meaningful improvement in desire and distress is observed. Liver function tests are recommended prior to initiation and periodically during treatment.
Precautions
Patients should be cautioned about the potential for severe hypotension and syncope, particularly in the setting of alcohol consumption. Concomitant use with moderate or strong CYP3A4 inhibitors is contraindicated. Use with caution in patients with hepatic impairment (not recommended in severe impairment). Monitor for signs of somnolence, sedation, and fatigue; patients should not drive or operate machinery until they know how flibanserin affects them. Blood pressure should be monitored in patients taking antihypertensives or other medications that may lower blood pressure. Not recommended for use in patients with a history of hypotension or syncope.
Contraindications
Concomitant use with alcohol. Concomitant use with moderate or strong CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, erythromycin, verapamil, grapefruit juice). Hepatic impairment (Child-Pugh B or C). Use in postmenopausal women or men. Hypersensitivity to flibanserin or any component of the formulation.
Possible side effects
Common adverse reactions (≥2% incidence and greater than placebo) include:
- Dizziness
- Somnolence
- Nausea
- Fatigue
- Insomnia
- Dry mouth
- Anxiety
Serious adverse reactions may include:
- Hypotension
- Syncope
- Central nervous system depression
- Accidental injury
Drug interaction
Flibanserin is primarily metabolized by CYP3A4 and CYP2C19. Concomitant use with moderate or strong CYP3A4 inhibitors is contraindicated. Weak CYP3A4 inhibitors may increase flibanserin exposure; consider alternative therapy. CYP2C19 inhibitors may also increase flibanserin levels. Concomitant use with other CNS depressants (e.g., benzodiazepines, narcotics, antipsychotics) may potentiate sedation and hypotension. Use with other medications that lower blood pressure may increase the risk of hypotension and syncope. Avoid concomitant use with alcohol.
Missed dose
If a dose is missed, it should be skipped. The next dose should be taken at the regular time the following evening. Do not double the dose to make up for a missed administration.
Overdose
In case of suspected overdose, symptomatic and supportive measures should be instituted. There is no specific antidote for flibanserin overdose. Given its pharmacological profile, overdose may manifest as severe hypotension, syncope, and profound sedation. Cardiovascular and respiratory monitoring is advised. Management may include intravenous fluids and vasopressors for hypotension. Gastric lavage or activated charcoal may be considered if ingestion was recent, though the rapid absorption may limit utility.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep in the original container, tightly closed, and protect from moisture. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging.
Disclaimer
This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read in this document. The efficacy and safety of flibanserin have been established only under the conditions outlined in the full prescribing information.
Reviews
Clinical trials and post-marketing surveillance have provided substantive data on flibanserin’s profile. In randomized, double-blind, placebo-controlled studies, women treated with flibanserin 100 mg daily reported a statistically significant increase in the number of satisfying sexual events (SSE) and a decrease in distress scores related to low sexual desire, compared to placebo. Patient-reported outcomes also indicated improvements in desire and overall sexual function. However, a notable proportion of participants discontinued treatment due to adverse events, underscoring the importance of patient selection, counseling, and adherence to the bedtime dosing regimen. Real-world evidence continues to be gathered to further characterize its effectiveness and tolerability in diverse clinical populations.