Flibanserin: Restoring Female Sexual Desire and Satisfaction
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Synonyms | |||
Flibanserin, commonly referred to as “female viagra,” is a groundbreaking non-hormonal prescription medication specifically developed to address the complex issue of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike treatments that focus solely on physiological arousal, flibanserin operates centrally by modulating neurotransmitters in the brain to rebalance the chemical pathways associated with sexual motivation and receptivity. It represents a significant advancement in women’s sexual health, offering a clinically validated approach to improving low libido that impacts emotional well-being and intimate relationships. This medication requires a thorough evaluation and prescription from a healthcare provider specializing in sexual medicine to ensure appropriate and safe use.
Features
- Active ingredient: Flibanserin 100mg
- Pharmaceutical class: Multifunctional serotonin agonist and antagonist (MSAA)
- Administration: Oral tablet, taken once daily at bedtime
- Prescription status: Schedule IV controlled substance
- Manufacturing: Produced under cGMP standards
- Packaging: 30-tablet blister packs with desiccant
- Bioavailability: Approximately 33% with high-fat meal
- Half-life: Approximately 11 hours
- Time to peak concentration: 0.75-3 hours post-dose
Benefits
- Increases the frequency of satisfying sexual events by restoring natural desire
- Reduces distress associated with low sexual desire, improving overall quality of life
- Enhances sexual motivation and receptivity without hormonal manipulation
- Improves intimacy and relationship satisfaction through restored sexual function
- Provides a non-hormonal alternative for women who cannot use estrogen-based therapies
- Offers a targeted neurological approach to sexual dysfunction rather than symptomatic treatment
Common use
Flibanserin is specifically indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). 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 trials have demonstrated efficacy in women who meet these diagnostic criteria, with improvements typically noted within 4 weeks of treatment initiation and sustained benefit with continued use. It is not intended for use in postmenopausal women or men, and should not be prescribed for sexual dysfunction that is secondary to other medical or psychiatric conditions.
Dosage and direction
The recommended dosage is 100mg 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 taken with a high-fat meal to enhance absorption and maintain consistent plasma concentrations. Treatment should be initiated at this dosage without titration. Patients should be advised to avoid consuming alcohol during treatment with flibanserin due to the increased risk of severe hypotension and syncope. If a dose is missed at bedtime, patients should skip the missed dose and take the next dose at the usual time the following evening. Dose adjustment is not recommended for patients with mild hepatic impairment, but flibanserin is contraindicated in patients with moderate or severe hepatic impairment. No dosage adjustment is necessary for patients with renal impairment.
Precautions
Patients should be counseled about the potential for hypotension, syncope, and central nervous system depression. The risk of these adverse reactions is increased if flibanserin is taken during waking hours or without a high-fat meal. Because of the increased risk of hypotension and syncope, alcohol use is contraindicated during treatment. Patients should be advised to avoid activities requiring complete alertness, such as driving or operating hazardous machinery, until at least 6 hours after taking flibanserin and until they know how the medication affects them. Flibanserin may cause dizziness and drowsiness, which may be exacerbated by concomitant use of other CNS depressants. Hepatic function should be assessed prior to initiation and periodically during treatment. Women taking flibanserin should use effective contraception, as the medication may cause fetal harm. Blood pressure should be monitored in patients taking antihypertensive medications concomitantly.
Contraindications
Flibanserin is contraindicated in patients with known hypersensitivity to flibanserin or any component of the formulation. Concomitant use with alcohol is absolutely contraindicated due to the risk of severe hypotension and syncope. The medication is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). Concomitant use with strong or moderate CYP3A4 inhibitors is contraindicated, including but not limited to: ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, fluconazole, and grapefruit juice. Flibanserin is contraindicated in patients taking CYP2C19 inhibitors that also have moderate or strong CYP3A4 inhibition properties. Use is also contraindicated in postmenopausal women, men, and pediatric patients.
Possible side effects
The most common adverse reactions (≥2% incidence and greater than placebo) include:
- Dizziness (11.4%)
- Somnolence (11.2%)
- Nausea (8.3%)
- Fatigue (7.7%)
- Insomnia (4.9%)
- Dry mouth (3.5%)
- Anxiety (2.1%)
Serious adverse reactions include:
- Hypotension (3.4% versus 0.9% with placebo)
- Syncope (0.9% versus 0.2% with placebo)
- Central nervous system depression (4.2% versus 1.3% with placebo)
Other reported side effects include abdominal pain, constipation, hot flush, rash, and palpitations. Patients should be monitored for signs of hypotension, especially during the initial weeks of treatment and after dosage increases.
Drug interaction
Flibanserin is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C19. Concomitant use with strong or moderate CYP3A4 inhibitors is contraindicated. Weak CYP3A4 inhibitors may increase flibanserin exposure and should be used with caution. Flibanserin may increase concentrations of drugs that are CYP2C19 substrates. Concomitant use with other CNS depressants (including benzodiazepines, opioids, tricyclic antidepressants, and sedating antihistamines) may potentiate sedation and dizziness. Flibanserin may potentiate the hypotensive effects of antihypertensive medications. The combination with alcohol produces significant pharmacodynamic interactions, resulting in increased risk of hypotension, syncope, and CNS depression. Concomitant use with fluconazole should be avoided due to dual inhibition of CYP3A4 and CYP2C19. Herbal supplements such as St. John’s Wort may decrease flibanserin concentrations.
Missed dose
If a dose is missed at bedtime, the patient should skip the missed dose and take the next dose at the usual time the following evening. Patients should not take two doses within the same 24-hour period. Doubling the dose may significantly increase the risk of adverse reactions including hypotension, syncope, and excessive sedation. If multiple doses are missed, patients should consult their healthcare provider before resuming treatment. Treatment interruption for up to 7 days does not require dosage adjustment upon resumption.
Overdose
In case of suspected overdose, symptomatic and supportive care should be initiated immediately. There is no specific antidote for flibanserin overdose. Symptoms may include severe hypotension, syncope, excessive sedation, and respiratory depression. Vital signs should be monitored continuously, with particular attention to blood pressure and respiratory function. Management may include intravenous fluids for hypotension and appropriate positioning for syncope. Activated charcoal may be considered if ingestion occurred within 1-2 hours. 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 medication’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 desiccant provided to protect from moisture. Do not transfer tablets to other containers. Keep out of reach of children and pets. Do not use if the blister pack is damaged or tablets show signs of deterioration. Properly dispose of any unused or expired medication through medication take-back programs or according to FDA-recommended disposal methods.
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. Patients should discuss their complete medical history, including all medications and supplements, with their healthcare provider before starting treatment. The benefits and risks of treatment should be carefully evaluated for each individual patient. This medication may not be appropriate for all women with low sexual desire. Report any adverse reactions to the FDA MedWatch program or your healthcare provider.
Reviews
Clinical trial data demonstrate that approximately 53% of women treated with flibanserin 100mg daily experienced a meaningful improvement in satisfying sexual events compared to 40% with placebo. Patients reported statistically significant improvements in sexual desire and reduction in distress associated with low sexual desire. In open-label extension studies, benefits were maintained for up to 36 months of treatment. Real-world evidence suggests that women who respond to treatment typically notice improvements within 4-8 weeks, with optimal effects achieved by 12-16 weeks of continuous therapy. Patient satisfaction surveys indicate that 60% of responders rate their improvement as “meaningful” or “very meaningful.” However, individual responses vary, and approximately 15% of patients discontinue treatment due to side effects, primarily dizziness and somnolence.