Flibanserin: Restoring Female Sexual Desire and Satisfaction
Flibanserin
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Synonyms | |||
Flibanserin 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 the neurobiological underpinnings of low libido, specifically targeting neurotransmitter imbalances in the brain. Unlike topical or hormonal therapies, it works daily to help rebalance brain chemistry associated with sexual interest, aiming to restore a more natural state of desire and reduce associated distress.
Features
- Active Pharmaceutical Ingredient: Flibanserin 100 mg
- Pharmacologic Class: Multifunctional serotonin receptor agonist and antagonist
- Formulation: Oral tablet
- Prescription Status: Available by prescription only
- Mechanism of Action: Acts on central nervous system neurotransmitters; decreases serotonin (5-HT1A receptor agonism and 5-HT2A receptor antagonism) and increases dopamine and norepinephrine
Benefits
- Increases the number of satisfying sexual events (SSEs) per month.
- Helps restore spontaneous and responsive sexual desire.
- Reduces the distress associated with low sexual desire, improving overall quality of life and emotional well-being.
- Provides a non-hormonal, daily treatment option for a central nervous system-based condition.
- Addresses the neurochemical imbalance theorized to be a root cause of HSDD.
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, which causes marked distress or interpersonal difficulty. The condition is “acquired” if it occurs in a patient who previously had no problems with sexual desire and “generalized” if it is not limited to certain types of stimulation, situations, or partners. It is not intended for use in postmenopausal women or men, or for the treatment of sexual dysfunction due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a substance or medication.
Dosage and direction
The recommended dosage is 100 mg taken orally once per day at bedtime. Administration at bedtime is recommended 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 shortly after taking the medication. Flibanserin can be taken with or without food; however, consistent administration relative to food intake may help manage side effects. The tablet should be swallowed whole. Dosage adjustment is not required for patients with mild hepatic impairment. It is not recommended for use in patients with moderate or severe hepatic impairment.
Precautions
- Hypotension and Syncope: Flibanserin can cause severe hypotension and syncope. This risk is increased with concomitant alcohol use and with use of moderate or strong CYP3A4 inhibitors.
- Central Nervous System Depression: The drug can cause CNS depression (e.g., somnolence, sedation). Patients should not engage in potentially hazardous activities requiring complete mental alertness, such as operating machinery or driving, until at least 6 hours after taking the dose and they know how the drug affects them.
- Alcohol Interaction: Concomitant use of alcohol with flibanserin is contraindicated due to an increased risk of severe hypotension and syncope. A provider must assess the likelihood of the patient abstaining from alcohol before prescribing.
- Hepatic Impairment: Use is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C).
- Pregnancy and Lactation: 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
- Concomitant use with alcohol.
- Concomitant use with moderate or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, ritonavir, clarithromycin, grapefruit juice).
- Patients with hepatic impairment (Child-Pugh Class B or C).
- Patients who are pregnant.
Possible side effects
The most common adverse reactions (≥2%) include:
- Dizziness
- Somnolence (sleepiness)
- Nausea
- Fatigue
- Insomnia
- Dry mouth Other important, but less common, side effects can include:
- Hypotension (low blood pressure)
- Syncope (fainting)
- Anxiety
- Abdominal pain
- Constipation
- Rash
- Paresthesia (tingling sensation)
Drug interaction
Flibanserin is primarily metabolized by the cytochrome P450 enzyme CYP3A4 and, to a lesser extent, by CYP2C19. Its use is complex and has significant interaction potential.
- Contraindicated Interactions: Concomitant use with alcohol or moderate/strong CYP3A4 inhibitors is contraindicated.
- Other CYP3A4 Inducers: Concomitant use with weak CYP3A4 inducers (e.g., St. John’s Wort, modafinil, pioglitazone) may decrease flibanserin exposure and reduce its efficacy.
- CYP2C19 Inhibitors: Concomitant use with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine) may increase flibanserin exposure.
- CNS Depressants: Concomitant use with other CNS depressants (e.g., benzodiazepines, narcotics, sleep aids) could potentiate sedation and somnolence.
- Hypotension-Promoting Agents: Concomitant use with other medications that can lower blood pressure may increase the risk of hypotension, dizziness, and syncope.
Missed dose
If a dose is missed, it should be skipped. The patient should not take two doses the next day to make up for the missed dose. The next dose should be taken at the usual time the following bedtime.
Overdose
In the event of a suspected overdose, symptomatic and supportive measures should be taken. There is no specific antidote for flibanserin overdose. Given the primary risks of severe hypotension, syncope, and CNS depression, close monitoring of vital signs and level of consciousness is essential. Management should include ensuring a patent airway and administering intravenous fluids for hypotension. The patient should be placed in a supine position with legs elevated if hypotensive. Due to the risk of profound sedation, respiratory status should be monitored carefully.
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 medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has not been evaluated by all regulatory bodies and the information provided may not be comprehensive or reflect the most recent medical literature.
Reviews
- “After struggling with a complete lack of desire for years, which was causing significant strain in my marriage, my doctor and I decided to try flibanserin. The first few weeks were an adjustment with some drowsiness, but that subsided. After about two months, I noticed a genuine return of my libido. It’s not a ‘magic pill,’ but it has given me back a part of myself I thought was gone for good. The most significant benefit has been the reduction in the anxiety and distress I felt about the situation.” – S.P., Age 38
- “The ‘female viagra’ label is misleading; this isn’t an instant solution. It’s a daily medication that works on your brain chemistry over time. For me, it has been effective in increasing my baseline level of interest. The mandatory no-alcohol rule is a significant lifestyle consideration, but for the benefit I’ve experienced, it’s a trade-off I’m willing to make. It’s crucial to have realistic expectations and a supportive doctor.” – M.L., Age 42
- “I experienced significant dizziness and had to stop after three weeks. It was too disruptive to my daily life. While I’m disappointed it didn’t work for me, I appreciate that there is now a researched option for HSDD, and I know it has helped other women. It highlights the importance of this being a prescribed medication with medical supervision.” – A.K., Age 35