Flibanserin: Restoring Female Sexual Desire and Satisfaction

Flibanserin
| Product dosage: 100mg | |||
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Synonyms | |||
Flibanserin is a groundbreaking, non-hormonal prescription medication specifically developed to address the complex condition of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. As the first FDA-approved treatment of its kind, it represents a significant advancement in women’s sexual health, targeting neurochemical pathways in the brain to help restore natural desire and reduce associated distress. This medication offers a clinically validated approach for those experiencing a persistent lack of sexual interest that causes personal concern, providing a pathway toward improved intimacy and overall quality of life. It is intended for use under careful medical supervision as part of a comprehensive treatment plan.
Features
- Active pharmaceutical ingredient: Flibanserin 100 mg
- Pharmacological class: Multifunctional serotonin agonist and antagonist (MSAA)
- Administration: Oral tablet
- Prescription status: Schedule IV controlled substance, Rx only
- Packaging: Available in 30-tablet monthly packs with child-resistant packaging
- Manufacturer: Certified pharmaceutical facilities following cGMP standards
- Stability: Shelf-stable formulation requiring no refrigeration
Benefits
- Increases spontaneous sexual desire and reduces distress associated with low libido
- Enhances satisfying sexual events frequency through central nervous system modulation
- Non-hormonal mechanism avoids systemic hormonal side effects
- Improves overall sexual satisfaction and intimacy in relationships
- Provides a targeted approach to neurochemical balance affecting sexual response
- Supported by clinical trials demonstrating statistically significant efficacy
Common use
Flibanserin is specifically indicated for the treatment of acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. HSDD is characterized by a persistent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by another medical condition, substance use, or severe relationship distress. The condition must be acquired (developing in a patient who previously had no problems with sexual desire) and generalized (not situational or partner-specific). Clinical studies have shown effect typically within 4-8 weeks of consistent use, with optimal results often observed by 12 weeks of treatment.
Dosage and direction
The recommended dosage is 100 mg taken orally once daily at bedtime. Administration at bedtime is crucial due to the risk of hypotension, syncope, and central nervous system depression. Tablets should be swallowed whole with water and not crushed, chewed, or split. Patients should avoid consuming alcohol during treatment with flibanserin due to potentially serious interactions. Treatment efficacy should be evaluated after 8 weeks of continuous use. If no meaningful improvement in sexual desire and associated distress is observed after discontinuing concomitant moderate or strong CYP3A4 inhibitors for at least 2 weeks, discontinuation of treatment should be considered.
Precautions
Patients should be cautioned about the risk of hypotension and syncope, particularly within the first few weeks of treatment. Blood pressure should be monitored, especially in patients taking antihypertensive medications. Due to CNS depression effects, patients should exercise caution when engaging in activities requiring complete mental alertness, such as operating machinery or driving, until they know how flibanserin affects them. Hepatic impairment requires dosage adjustment or avoidance, as flibanserin is extensively metabolized by the liver. Patients should be monitored for signs of depression or changes in mood. Use with caution in patients with a history of depression or other psychiatric disorders.
Contraindications
Flibanserin is contraindicated in patients with hepatic impairment. Concomitant use with strong or moderate CYP3A4 inhibitors is prohibited, including medications such as ketoconazole, fluconazole, erythromycin, and verapamil. Use with alcohol is absolutely contraindicated due to the risk of severe hypotension and syncope. Pregnancy and breastfeeding are contraindications due to unknown fetal risk and potential for serious adverse reactions in nursing infants. Concomitant use with other CNS depressants should be avoided. Patients with a history of hypersensitivity to flibanserin or any component of the formulation should not use this medication.
Possible side effects
Common adverse reactions (≥2%) include dizziness (11.4%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (3.3%). Syncope has been reported in 0.4% of patients at the 100 mg dose. Hypotension occurred in 0.2% of patients. Less common side effects include anxiety, palpitations, and abdominal pain. Most side effects are dose-related and often diminish with continued use. Patients should report persistent or severe side effects to their healthcare provider immediately, particularly signs of hypotension such as lightheadedness, dizziness, or feeling faint.
Drug interaction
Flibanserin is primarily metabolized by CYP3A4 and secondarily by CYP2C19. Concomitant use with strong CYP3A4 inhibitors increases flibanserin exposure approximately 7.5-fold and is contraindicated. Moderate CYP3A4 inhibitors increase exposure approximately 4-fold and are also contraindicated. Weak CYP3A4 inhibitors may increase flibanserin exposure by approximately 1.8-fold and require careful monitoring. Concomitant use with alcohol significantly increases the risk of severe hypotension and syncope. CNS depressants, including benzodiazepines, narcotics, and sleep aids, may potentiate sedation effects. Flibanserin may increase exposure to drugs that are CYP2C9 substrates. Healthcare providers should conduct a comprehensive medication review before initiation.
Missed dose
If a dose is missed at the usual bedtime time, the patient should skip the missed dose and take the next dose at the regular time the following bedtime. Patients should never double the dose to make up for a missed dose due to the increased risk of adverse effects. If vomiting occurs shortly after taking flibanserin, the dose should not be repeated that same night. Consistent daily administration is important for maintaining therapeutic effect, but occasional missed doses are not expected to significantly impact overall efficacy.
Overdose
In case of suspected overdose, immediate medical attention should be sought. Symptoms may include severe hypotension, syncope, and profound sedation. There is no specific antidote for flibanserin overdose. Treatment should consist of supportive measures, including continuous hemodynamic monitoring and appropriate management of hypotension. Activated charcoal may be considered if administered within one hour of ingestion. Hemodialysis is unlikely to be effective due to flibanserin’s high protein binding and extensive tissue distribution. Patients should be monitored for at least 24 hours due to the drug’s half-life of approximately 11 hours.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture and light. Keep out of reach of children and pets. Do not use if the packaging is damaged or shows signs of tampering. Properly discard any unused medication after the expiration date printed on the packaging. Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Flibanserin is available by prescription only and should be used under the direct supervision of a qualified healthcare provider. Individual results may vary, and not all patients will experience the described benefits. Patients should discuss their complete medical history, including all medications and supplements, with their healthcare provider before starting treatment. This medication is not intended for use in men, postmenopausal women, or for the enhancement of sexual performance.
Reviews
Clinical trial data demonstrate that 46-60% of women treated with flibanserin 100 mg daily experienced meaningful improvement in sexual desire, compared to 29-38% with placebo. Patients reported approximately 0.8-1.0 additional satisfying sexual events per month over placebo. In open-label extension studies, improvements were maintained for up to 36 months of treatment. Real-world evidence suggests similar efficacy patterns, though individual responses vary based on underlying factors contributing to HSDD. Patient-reported outcomes indicate significant reduction in distress associated with low sexual desire, with many women reporting improved relationship satisfaction and quality of life.