In 2015, the U.S. Food and Drug Administration (FDA) made history by approving Flibanserin, the first treatment for female sexual dysfunction, specifically addressing hypoactive sexual desire disorder (HSDD) in premenopausal women. Marketed under the brand name Addyi. This medication provides an option for women experiencing distress due to low sexual desire. This approval represents a significant advancement in recognizing and addressing female sexual health needs. Flibanserin (Addyi) is a Viagra-like drug for cisgender women and others assigned female at birth.
FDA Approval and Clinical Trials
The FDA approved Flibanserin after many clinical trials showed it can help women with low sexual desire. Here are the key points:
- Effectiveness: Flibanserin was found to increase the number of satisfying sexual experiences and reduce distress about low sexual desire.
- Trial Results: In clinical trials, women who took Flibanserin had a noticeable increase in sexual desire and less distress compared to those who took a placebo (a sugar pill).
Understanding HSDD and the Need for Flibanserin
Hypoactive sexual desire disorder (HSDD) is a condition where women feel a lack of sexual desire that causes distress. Unlike physical issues that affect sexual function, HSDD is often linked to the brain’s chemicals, like serotonin, dopamine, and norepinephrine, which play an essential role in regulating mood and desire.
Historically, treatments for sexual dysfunction were focused on men, such as Viagra for erectile dysfunction. This left a gap for women with specific problems like HSDD. Now, with Flibanserin, women have a treatment approved by the FDA that works directly on the brain to help increase sexual desire.
How Flibanserin Works
Unlike drugs like Viagra, which work on blood flow to address erectile dysfunction, Flibanserin works on the brain’s chemical balance, particularly targeting the neurotransmitters that affect sexual desire.
Flibanserin lowers serotonin levels and increases dopamine and norepinephrine, which can help to improve sexual desire and reduce the distress caused by HSDD.
Who Can Take Flibanserin?
Flibanserin is approved for premenopausal women who have been diagnosed with hypoactive sexual desire disorder (HSDD).
How to Take Flibanserin
For the best results, Flibanserin should be taken as directed by a healthcare provider.
The standard dosage is 100 mg taken once daily at bedtime. Taking the medication at bedtime helps to minimize the risk of side effects, such as dizziness or sleepiness, during the day.
- Missed Doses: If you miss a dose, skip it and take the next dose at your regular bedtime the following night. Do not double the dose to make up for a missed dose.
- When to Stop: If you don’t notice any improvement in your symptoms after 8 weeks, it’s recommended to stop using the medication, as it’s unlikely to work after that time.
Flibanserin Side Effects
Like many medications, Flibanserin comes with its own set of side effects, although they are generally mild for most users.
Common Side Effects:
- Dizziness
- Sleepiness
- Nausea
- Fatigue
- Dry mouth
- Tiredness
- Low blood pressure, also known as hypotension
- Fainting or loss of consciousness
Here are the Flibanserin warnings:
Avoid Alcohol: Women should not drink alcohol while taking Flibanserin to prevent severe side effects like low blood pressure and fainting.
Medication Interactions: Flibanserin can interact with certain medications, such as antifungal drugs and blood pressure medications, potentially increasing side effects.
Benefits and Limitations of Flibanserin
Benefits:
Addresses a neurological cause of HSDD: Flibanserin offers a unique solution to a problem that has historically been overlooked, directly affecting the neurotransmitters that influence desire.
Improves overall sexual satisfaction: Studies show that women taking Flibanserin experience more frequent satisfying sexual experiences and reduced distress about low desire.
Non-hormonal treatment: Flibanserin offers an alternative to hormone-based therapies, appealing to women who prefer not to use hormonal treatments.
Limitations:
Not an immediate solution: Unlike Viagra, which works quickly, Flibanserin must be taken daily, with results building over time, often requiring 8 weeks of consistent use before the full effects are realized.
Limited to premenopausal women: While it addresses an important issue, Flibanserin is not suitable for all women, particularly postmenopausal women or those with sexual dysfunction caused by factors other than HSDD.
Warning:
Flibanserin has a boxed warning because it can cause severe low blood pressure and fainting, especially when mixed with alcohol or certain medications.
Conclusion: A Step Forward for Female Sexual Health
Flibanserin may not be perfect, but its approval was a landmark moment in women's sexual health. It addresses an area of female sexual dysfunction that has long been ignored, providing a treatment option for women suffering from HSDD. While the medication has limitations and potential side effects, it is a step forward in recognizing and treating the complex nature of female sexual desire. As more research is conducted and awareness grows, Flibanserin may pave the way for more advanced treatments that continue to empower women to take control of their sexual health.
For now, it remains a valuable tool for premenopausal women struggling with HSDD, offering hope for improved sexual satisfaction and quality of life.
