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. Unlike treatments that address physiological aspects of sexual function, flibanserin works on neurotransmitter systems in the brain to help restore balance and improve spontaneous sexual desire and associated distress. It represents a significant advancement in addressing a complex and often overlooked aspect of women’s health, offering a clinically validated option for those experiencing this specific form of sexual dysfunction.
Features
- Active ingredient: Flibanserin 100 mg
- Pharmacological class: Multifunctional serotonin agonist and antagonist (MSAA)
- Administration: Oral tablet, taken once daily at bedtime
- Prescription status: Available by prescription only after thorough medical evaluation
- Mechanism of action: Modulates neurotransmitters; decreases serotonin activity and increases dopamine and norepinephrine to target desire
- FDA-approved indication: For premenopausal women with acquired, generalized HSDD
Benefits
- Increases the frequency of satisfying sexual events and desire
- Reduces distress associated with low sexual desire
- Non-hormonal mechanism avoids systemic hormonal side effects
- Once-daily dosing supports treatment adherence
- Improves overall sexual satisfaction and intimacy
- Addresses the neurochemical basis of desire, not just symptoms
Common use
Flibanserin is specifically indicated for premenopausal women diagnosed 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, causing marked distress or interpersonal difficulty, which is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. It is intended for daily use to achieve and maintain therapeutic effect and is not an as-needed medication.
Dosage and direction
The recommended dosage is 100 mg taken orally once daily, at bedtime. Taking it at bedtime is advised to mitigate the risk of hypotension, syncope, and central nervous system depression such as somnolence. It can be taken with or without food; however, consumption with alcohol is contraindicated. Dosage adjustment is not recommended for patients with mild hepatic impairment but is contraindicated in those with moderate or severe hepatic impairment. Treatment efficacy should be re-evaluated after 8 weeks of use.
Precautions
Patients should be advised of the potential for severe hypotension and syncope, particularly in the setting of concomitant alcohol use. Due to central nervous system depression (e.g., somnolence, sedation), patients should exercise caution when engaging in activities requiring full alertness, such as operating machinery or driving, until they know how flibanserin affects them. Use of other CNS depressants (e.g., benzodiazepines, narcotics, sleep aids) may potentiate these effects. Blood pressure should be monitored in patients taking antihypertensive medications or other drugs that can lower blood pressure.
Contraindications
Flibanserin is contraindicated in patients with hepatic impairment (Child-Pugh B or C). Concomitant use with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, erythromycin) is contraindicated due to significantly increased flibanserin exposure and associated risks. Use with alcohol is absolutely contraindicated due to the increased risk of severe hypotension and syncope. It is also contraindicated in postmenopausal women, men, and patients with a known hypersensitivity to flibanserin or any component of the formulation.
Possible side effects
Common adverse reactions (≥2% incidence and greater than placebo) include:
- Dizziness
- Somnolence (sleepiness)
- Nausea
- Fatigue
- Insomnia
- Dry mouth
- Hypotension
- Syncope (fainting)
Serious side effects can include hypotension, syncope, and central nervous system depression. Patients should be aware of the signs of hypotension (e.g., lightheadedness, dizziness) and should sit or lie down if these occur.
Drug interaction
Flibanserin is primarily metabolized by CYP3A4 and, to a lesser extent, by CYP2C19. Concomitant use is contraindicated with strong and moderate CYP3A4 inhibitors. Concomitant use with other CNS depressants (including alcohol) increases the risk of hypotension, syncope, and CNS depression. Use with other medications that can lower blood pressure may have additive hypotensive effects. Concomitant use with CYP2C19 inhibitors (e.g., proton pump inhibitors like omeprazole) may increase flibanserin exposure. Healthcare providers should review all concomitant medications prior to initiation.
Missed dose
If a dose is missed, it should be skipped, and the next dose should be taken at the regular time the following bedtime. Do not double the dose to make up for a missed one, as this increases the risk of adverse effects such as hypotension and syncope.
Overdose
In case of suspected overdose, symptomatic and supportive measures should be instituted. Given the drug’s potential to cause severe hypotension and CNS depression, close medical supervision and monitoring of vital signs are essential. There is no specific antidote for flibanserin overdose. Management should include ensuring a patent airway and administering intravenous fluids for hypotension if needed.
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, tightly closed, and protect from moisture and light. Keep out of reach of children and pets.
Disclaimer
This information is intended for educational purposes 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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read herein.
Reviews
Clinical trials and post-marketing studies have demonstrated that flibanserin provides a statistically significant increase in the number of satisfying sexual events (SSEs) and a decrease in distress associated with low sexual desire compared to placebo over 24 weeks of treatment. Patient-reported outcomes indicate meaningful improvement in desire for a subset of women with HSDD. However, individual responses can vary, and the benefit must be weighed against the risk of side effects, particularly concerning hypotension and sedation. Adherence to prescribing guidelines and contraindications is critical for patient safety.