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 neurotransmitters implicated in sexual response, specifically targeting the dissonance between inhibitory and excitatory pathways. This non-hormonal, daily oral treatment is the first FDA-approved medication of its kind, offering a clinically validated option for a condition that has historically been underserved by therapeutic interventions. Its development marks a pivotal shift toward addressing the neurobiological underpinnings of female sexual dysfunction.
Features
- Active ingredient: Flibanserin 100 mg
- Pharmacological class: Multifunctional serotonin receptor agonist and antagonist
- Administration: Oral tablet
- Recommended dosage: 100 mg once daily at bedtime
- Prescription status: Available only under healthcare provider supervision
- Mechanism of action: Modulates serotonin (5-HT1A agonist, 5-HT2A antagonist) and dopamine receptors in brain areas associated with sexual desire
Benefits
- Clinically proven to increase the number of satisfying sexual events (SSEs)
- Demonstrates a significant improvement in sexual desire scores as measured by validated patient-reported outcomes
- Reduces distress associated with low sexual desire, improving overall quality of life
- Offers a non-hormonal treatment alternative for premenopausal women with HSDD
- Functions through a targeted central nervous system mechanism, addressing the neurobiological basis of desire
- Supported by robust clinical trial data involving thousands of participants
Common use
Flibanserin is indicated for the treatment of premenopausal women with acquired, generalized Hypoactive Sexual Desire Disorder (HSDD). HSDD is characterized by a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity, causing marked distress or interpersonal difficulty, which is not better accounted for by a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. The diagnosis of acquired, generalized HSDD requires that the low desire must have developed in a patient who previously had no problems with sexual desire, and it must occur regardless of the type of sexual activity, situation, or partner.
Dosage and direction
The recommended dosage is 100 mg taken orally once daily, at bedtime. Administration at bedtime is intended to mitigate the risk of certain adverse reactions, such as hypotension, syncope, and central nervous system depression (e.g., somnolence, sedation), which are more likely to occur if the patient is ambulatory. The tablet should be swallowed whole and can be taken with or without food; however, consistent administration relative to food may help manage variability in absorption. Patients should be advised to avoid alcohol consumption during treatment with flibanserin due to a significant interaction that increases the risk of severe hypotension and syncope. Dose adjustment is not required for patients with mild hepatic impairment; however, flibanserin is not recommended for use in patients with moderate or severe hepatic impairment.
Precautions
Prior to initiating treatment, a thorough clinical assessment should be conducted to confirm the diagnosis of HSDD and to rule out other causes of low libido. Healthcare providers should assess the patient’s overall health status, with particular attention to conditions or medications that could lower blood pressure or cause sedation. Patients should be counseled extensively on the risks associated with alcohol use during therapy. Due to the potential for dizziness, somnolence, and fatigue, patients should exercise caution when engaging in activities requiring full alertness, such as operating machinery or driving, especially during the initial stages of treatment or after a dosage increase. Blood pressure should be monitored in patients taking concomitant medications known to lower blood pressure. Use is not recommended in patients with a history of hypotension or syncope.
Contraindications
Flibanserin is contraindicated in the following patient populations:
- Patients with a known hypersensitivity to flibanserin or any component of the formulation.
- Patients with hepatic impairment classified as moderate or severe (Child-Pugh Class B or C).
- Concomitant use with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, erythromycin, verapamil, diltiazem, grapefruit juice).
- Concomitant use with other central nervous system depressants.
- Concomitant consumption of alcohol.
Possible side effects
The most common adverse reactions (occurring in ≥2% of patients and more frequently than with placebo) associated with flibanserin include:
- Dizziness
- Somnolence (sleepiness)
- Nausea
- Fatigue
- Insomnia
- Dry mouth
- Other reported side effects can include anxiety, flushing, abdominal pain, and constipation. Of significant clinical importance are the risks of hypotension, syncope (fainting), and central nervous system depression. These events were observed more frequently in patients who consumed alcohol during treatment. The incidence of syncope in clinical trials was approximately 0.4% in flibanserin-treated patients versus 0.2% in placebo-treated patients when alcohol was prohibited.
Drug interaction
Flibanserin is primarily metabolized by the cytochrome P450 enzyme CYP3A4 and, to a lesser extent, by CYP2C19. Its pharmacokinetic profile makes it susceptible to numerous clinically significant drug interactions:
- Strong/Moderate CYP3A4 Inhibitors: Concomitant use is contraindicated. These drugs (e.g., ketoconazole, itraconazole, nefazodone, clarithromycin, diltiazem) can drastically increase flibanserin exposure, elevating the risk of severe hypotension and syncope.
- CYP2C19 Inhibitors: Concomitant use with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine) may increase flibanserin concentrations. Caution is advised.
- CNS Depressants: Concomitant use with other agents that cause CNS depression (e.g., benzodiazepines, opioids, antipsychotics, sedating antihistamines) may potentiate sedative effects and is not recommended.
- Alcohol: Concomitant use is contraindicated. Alcohol interaction studies demonstrated a significant increase in the risk of hypotension, syncope, and CNS depression.
- Other Hypotensive Agents: Additive hypotensive effects may be seen when used with antihypertensives, alpha-blockers, or PDE5 inhibitors. Blood pressure should be monitored.
Missed dose
If a dose is missed, the patient should skip the missed dose and take the next scheduled dose at the usual time the following bedtime. Patients should not take a double dose to make up for a missed one. Doubling the dose significantly increases the risk of adverse effects such as severe hypotension and syncope.
Overdose
There is limited clinical experience with flibanserin overdose. Based on its pharmacological profile, the manifestations of overdose would be expected to be an exaggeration of its known adverse effects, including severe hypotension, syncope, and profound CNS depression (somnolence, sedation). In case of suspected overdose, symptomatic and supportive measures should be initiated. This includes continuous cardiovascular and respiratory monitoring. Management of hypotension should include placing the patient in a supine position with legs elevated and administering intravenous fluids. Vasopressors may be considered if necessary. As flibanserin is highly protein-bound, dialysis is not expected to be an effective means of enhancing elimination.
Storage
Flibanserin tablets should be stored at room temperature, between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). The medication must be kept in its original container to protect it from light and moisture. It should be kept out of reach of children and pets. Unused or expired medication should be disposed of properly via a medicine take-back program or according to FDA-recommended disposal guidelines (do not flush).
Disclaimer
This information is intended for educational and informational purposes only and does not constitute medical advice. It 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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read herein. The efficacy and safety of flibanserin have been established only for its approved indication in premenopausal women. The information provided was accurate based on the manufacturer’s prescribing information at the time of writing, but may not be exhaustive. Always refer to the latest official prescribing information.
Reviews
Clinical trials and post-marketing studies have provided a substantial evidence base for flibanserin. In randomized, double-blind, placebo-controlled trials, premenopausal women with HSDD treated with 100 mg of flibanserin daily demonstrated a statistically significant increase from baseline in the number of satisfying sexual events (SSEs) and sexual desire (as measured by the Female Sexual Function Index [FSFI] desire domain score), alongside a decrease in distress related to sexual desire (as measured by the Female Sexual Distress Scale-Revised [FSDS-R] Item 13). Expert reviews in journals of psychiatry and gynecology often highlight its role as a pioneering, centrally-acting agent that validates the neurobiological model of female sexual desire, while also emphasizing the critical importance of patient selection, thorough risk-benefit discussion, and strict adherence to the alcohol contraindication to ensure patient safety.