Flibanserin: Restoring Female Sexual Desire and Satisfaction
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Synonyms | |||
Flibanserin, commonly referred to as “female viagra,” is a non-hormonal, centrally-acting medication approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It represents a significant advancement in addressing a complex neurobiological condition, targeting neurotransmitter systems in the brain to help restore balance and improve sexual motivation. Unlike treatments that focus solely on physiological arousal, this medication works on the central nervous system to enhance spontaneous and responsive sexual desire, thereby improving overall sexual satisfaction and reducing associated distress.
Features
- Active ingredient: Flibanserin 100 mg
- Pharmacological class: Multifunctional serotonin agonist and antagonist (5-HT1A receptor agonist and 5-HT2A receptor antagonist)
- Administration: Oral tablet
- Prescription status: Available by prescription only following thorough clinical assessment
- Packaging: Typically supplied in 30-tablet monthly packs with child-resistant packaging
- Manufacturer compliance: Produced under current Good Manufacturing Practices (cGMP)
Benefits
- Increases the frequency of satisfying sexual events by addressing central desire mechanisms
- Reduces distress associated with low sexual desire, improving overall quality of life
- Works on brain chemistry to help restore natural sexual motivation without hormonal manipulation
- Provides a targeted approach for premenopausal women with acquired, generalized HSDD
- Non-hormonal mechanism avoids systemic hormonal side effects
- Clinical studies demonstrate statistically significant improvement in desire scores and distress measures
Common use
Flibanserin is specifically indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder. 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 assessment should rule out other potential causes of low desire including endocrine disorders, medication side effects, psychiatric conditions, or relationship factors that would require alternative interventions.
Dosage and direction
The recommended dosage is 100 mg taken orally once daily at bedtime. Administration at bedtime is crucial to minimize the risk of hypotension, syncope, and central nervous system depression. The tablet should be swallowed whole with water and not crushed, chewed, or split. Patients should avoid consuming alcohol during treatment with flibanserin due to the risk of severe hypotension and syncope. Treatment efficacy should be evaluated after 8 weeks of continuous therapy. If insufficient response is observed after this period, discontinuation should be considered. Dose adjustment is not recommended for patients with mild hepatic impairment, but the medication is contraindicated in patients with moderate or severe hepatic impairment.
Precautions
Patients should be thoroughly counseled about the risk of hypotension and syncope, particularly in the initial weeks of treatment or following dosage increases. Caution is advised when using concomitant medications that are moderate or strong CYP3A4 inhibitors, as they can significantly increase flibanserin exposure. Blood pressure should be monitored periodically, especially when initiating treatment. Patients should be advised to avoid activities requiring complete alertness, such as driving or operating machinery, until they know how the medication affects them. The medication may cause central nervous system depression; concurrent use with other CNS depressants should be approached with caution. Hepatic function should be assessed prior to initiation and periodically during treatment.
Contraindications
Flibanserin is contraindicated in patients with hepatic impairment (Child-Pugh Class B or C). Concomitant use with strong or moderate CYP3A4 inhibitors is absolutely contraindicated, including medications such as ketoconazole, itraconazole, nefazodone, ritonavir, clarithromycin, grapefruit juice, and others. The medication is contraindicated in patients with a history of hypersensitivity to flibanserin or any component of the formulation. Use during pregnancy is contraindicated unless the potential benefit justifies the potential risk to the fetus. Concomitant alcohol consumption is contraindicated due to the risk of severe hypotension and syncope.
Possible side effects
The most commonly reported adverse reactions include:
- Dizziness (11.4%)
- Somnolence (11.2%)
- Nausea (8.3%)
- Fatigue (7.5%)
- Insomnia (4.9%)
- Dry mouth (3.5%)
- Hypotension (2.5%)
- Syncope (0.4%)
Less common but serious adverse effects may include hypotension requiring medical intervention, syncope with loss of consciousness, and central nervous system depression. Most adverse reactions are mild to moderate in severity and tend to decrease in frequency with continued treatment. Patients should be monitored for the development of any concerning symptoms, particularly during the initial weeks of therapy.
Drug interaction
Flibanserin is primarily metabolized by CYP3A4 and CYP2C19 enzymes and has multiple significant drug interactions. 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. Concomitant use with alcohol significantly increases the risk of severe hypotension and syncope and is absolutely contraindicated. Flibanserin may enhance the effects of CNS depressants including benzodiazepines, opioids, and sedating antihistamines. Use with other medications that affect blood pressure may potentiate hypotensive effects. Healthcare providers should conduct a comprehensive medication review before initiation and during treatment.
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 evening. Patients should not take a double dose to make up for a missed dose. If vomiting occurs shortly after taking flibanserin, the dose should not be repeated that same evening. Consistent daily administration is important for maintaining therapeutic effect, but occasional missed doses are not expected to significantly impact overall treatment efficacy.
Overdose
In case of suspected overdose, symptomatic and supportive care should be initiated immediately. Medical attention should be sought promptly. Symptoms of overdose may include severe hypotension, syncope, and marked central nervous system depression. There is no specific antidote for flibanserin overdose. Management should include continuous blood pressure monitoring, ECG monitoring, and appropriate supportive measures. Hemodialysis is unlikely to be effective due to flibanserin’s high protein binding and extensive tissue distribution. Gastric lavage or activated charcoal may be considered if presentation is early after ingestion.
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 appears tampered with or if tablets show signs of discoloration or deterioration. Properly discard any unused medication after the expiration date printed on the packaging.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Flibanserin is available by prescription only and should be used under the 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 should only be used for its FDA-approved indication after thorough evaluation and diagnosis by a qualified medical professional.
Reviews
Clinical trials demonstrate that flibanserin treatment results in statistically significant improvements in the number of satisfying sexual events and sexual desire scores compared to placebo. In phase III clinical trials, treatment with flibanserin 100 mg once daily at bedtime resulted in approximately 0.5-1.0 additional satisfying sexual events per month and significant improvements in desire scores measured by validated questionnaires. Patient-reported outcomes showed meaningful reduction in distress associated with low sexual desire. Real-world evidence continues to support the efficacy and safety profile observed in clinical trials, though individual responses vary based on numerous factors including adherence to dosing instructions, concomitant medications, and underlying medical conditions.