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 prescription medication approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike medications that address physiological aspects of sexual function, flibanserin works on neurotransmitter systems in the brain to rebalance chemistry associated with sexual interest. It represents a significant advancement in the medical management of this complex condition, offering a targeted approach for women experiencing distressing low libido not attributable to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. This product card provides a comprehensive, expert-level overview of its use, mechanism, and safety profile.
Features
- Active Ingredient: Flibanserin 100 mg.
- Pharmacologic Class: Multimodal serotonin receptor agonist and antagonist.
- Mechanism of Action: Modulates neurotransmitters in the brain; decreases serotonin activity (5-HT1A receptor agonism and 5-HT2A receptor antagonism) while increasing dopamine and norepinephrine levels.
- Administration: Oral tablet.
- Prescription Status: Available by prescription only following a thorough clinical evaluation.
- Treatment Paradigm: Designed for daily, chronic use to maintain effect, not for on-demand use.
Benefits
- Increases the number of satisfying sexual events (SSEs) as reported in clinical trials.
- Enhances sexual desire by targeting the neurobiological pathways in the brain responsible for excitatory and inhibitory sexual signals.
- Reduces distress associated with low sexual desire, improving overall emotional well-being and self-image.
- Provides a non-hormonal treatment option for premenopausal women, avoiding the risks associated with exogenous hormone therapies.
- Improves overall sexual function scores across validated patient-reported outcome measures.
Common use
Flibanserin is specifically indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Acquired HSDD refers to a condition that develops in a patient who previously had no problems with sexual desire. Generalized HSDD means the low desire occurs regardless of the type of sexual activity, situation, or partner. Its use is predicated on a formal diagnosis by a healthcare provider, which involves ruling out other potential causes of low libido, such as underlying medical conditions (e.g., endocrine disorders), psychiatric comorbidities (e.g., major depressive disorder), relationship issues, or side effects from other medications (e.g., SSRIs). It is not intended for use in postmenopausal women or men.
Dosage and direction
- The recommended dosage is 100 mg taken orally once per day at bedtime.
- Administration at bedtime is mandatory to mitigate the risk of severe hypotension and syncope (fainting), which are known side effects that can be exacerbated by alcohol consumption and fatigue.
- The tablet should be swallowed whole and can be taken with or without food.
- Consistent daily use is required for efficacy. Clinical trials demonstrated that improvement in desire and distress may be observed as early as 4 weeks, with further improvement occurring at 8 and 24 weeks of treatment.
- Do not increase the dose or take more than one tablet per day.
Precautions
- Alcohol Contraindication: Patients must be advised to discontinue drinking alcohol at least two hours before taking flibanserin at bedtime, or to skip that evening’s dose if they have consumed alcohol. Concomitant use significantly increases the risk of severe hypotension and syncope.
- Hepatic Impairment: Flibanserin is not recommended in patients with hepatic impairment. It is contraindicated in patients with Child-Pugh Class B and C hepatic impairment.
- Hypotension and Syncope: Patients should be aware of the symptoms of low blood pressure (dizziness, lightheadedness) and fainting. They should lie down if such symptoms occur and remain lying down until symptoms subside.
- Central Nervous System Depression: Flibanserin can cause central nervous system (CNS) depression (e.g., somnolence, sedation). Patients should exercise caution when engaging in activities requiring full alertness, such as driving or operating machinery, until they know how the medication affects them.
- Pregnancy and Nursing: There are no adequate data on the developmental risk associated with flibanserin use in pregnant women. It is not indicated for use during pregnancy. It is unknown if flibanserin is present in human milk; a risk to the breastfed infant cannot be ruled out.
Contraindications
Flibanserin is contraindicated in the following patient populations and scenarios:
- Concomitant use with moderate or strong CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, erythromycin, verapamil, diltiazem, grapefruit juice). This combination drastically increases flibanserin exposure.
- Patients with known hepatic impairment (Child-Pugh Class B and C).
- Concomitant use with alcohol.
- Concomitant use with other CNS depressants (e.g., benzodiazepines, narcotics, sleep aids).
Possible side effect
The most common adverse reactions (≥2% incidence and greater than placebo) observed in clinical trials include:
- Dizziness
- Somnolence (sleepiness)
- Nausea
- Fatigue
- Insomnia
- Dry mouth
- Hypotension (low blood pressure) and orthostatic hypotension
- Syncope (fainting) Most side effects are mild to moderate in severity. The incidence of syncope in clinical trials was approximately 0.4% in flibanserin-treated patients versus 0.2% in placebo-treated patients. The risk of syncope and hypotension is significantly increased with alcohol use.
Drug interaction
Flibanserin is primarily metabolized by the cytochrome P450 CYP3A4 enzyme system and, to a lesser extent, by CYP2C19. This makes it highly susceptible to drug-drug interactions.
- Strong/Moderate CYP3A4 Inhibitors: Contraindicated. Concomitant use causes a massive increase in flibanserin plasma levels, dramatically raising the risk of severe hypotension, syncope, and CNS depression. Examples include ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, verapamil, diltiazem, and grapefruit juice.
- Weak CYP3A4 Inhibitors: Use with caution. May increase flibanserin concentration. Examples include oral contraceptives, ginkgo biloba, and cimetidine.
- CYP2C19 Inhibitors: Concomitant use with strong CYP2C19 inhibitors (e.g., fluvoxamine) may increase flibanserin exposure. Caution is advised.
- CNS Depressants: Concomitant use with other agents that cause CNS depression (e.g., benzodiazepines, opioids, antipsychotics, antidepressants, sedating antihistamines) may increase the risk of sedation and somnolence.
- CYP3A4 Inducers: Concomitant use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort) may decrease flibanserin plasma concentrations, potentially reducing its efficacy.
Missed dose
If a dose is missed, it should be skipped. The patient should not take a double dose the next day to make up for the missed dose. They should resume their regular dosing schedule of one tablet at bedtime the following night.
Overdose
In the event of a suspected overdose, medical attention should be sought immediately. There is no specific antidote for flibanserin overdose. Based on its known pharmacological effects, the primary expected manifestations of overdose would be a pronounced exaggeration of its adverse effects: severe hypotension, syncope, and profound CNS depression (somnolence, sedation). Treatment should consist of supportive measures, including continuous ECG and vital sign monitoring, and management of hypotension. Due to high protein binding, flibanserin is not expected to be dialyzable.
Storage
- Store flibanserin tablets at room temperature, between 20°C to 25°C (68°F to 77°F).
- Excursions are permitted between 15°C and 30°C (59°F and 86°F).
- Keep the medication in its original container to protect it from light and moisture.
- Keep out of reach of children and pets.
Disclaimer
This information is for educational purposes only 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 here. The information provided is based on the manufacturer’s prescribing information and clinical trial data but may not be exhaustive.
Reviews
- Clinical Trial Data (Pooled Analysis): In randomized, placebo-controlled trials involving over 3,000 premenopausal women with HSDD, flibanserin 100 mg daily demonstrated a statistically significant increase from baseline in the number of satisfying sexual events (SSEs) and sexual desire score, alongside a significant decrease in distress score related to low sexual desire, compared to placebo. The therapeutic effect was sustained over 24 weeks of treatment.
- Patient Reported Outcomes: Many women in clinical practice report a meaningful improvement in spontaneous and responsive sexual desire, a decrease in the anxiety and distress surrounding their sexual relationship, and an overall improvement in sexual satisfaction. The necessity of avoiding alcohol is frequently cited as a significant lifestyle consideration.
- Expert Consensus (Medical Community): Flibanserin is recognized by specialists in sexual medicine as a valuable, though not first-line, tool for managing HSDD. Its use requires careful patient selection, extensive education on risks (especially regarding alcohol), and management of expectations, as the effect is modest and requires chronic administration. It is considered a serious pharmacologic intervention for a legitimate medical condition.