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Brief Explanation of Flibanserin

Flibanserin, sold under the brand name Addyi, is a medication developed and approved specifically for treating hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is a condition characterized by low sexual desire that causes personal distress or interpersonal difficulties and isn’t due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

Flibanserin is not a hormonal medication. Instead, it works by affecting the balance of certain chemicals in the brain, namely dopamine, norepinephrine, and serotonin, which are all involved in sexual desire and pleasure.

It’s important to note that Flibanserin is not a “female Viagra” as it is sometimes mistakenly called. Viagra works on a man’s physical response to sexual stimulation, specifically by enhancing blood flow to the penis to facilitate an erection, while Flibanserin works on the neurochemical aspects of sexual desire in the brain.

Flibanserin is taken once daily at bedtime to help limit certain side effects. Its use comes with a risk of serious side effects, including low blood pressure and loss of consciousness, particularly when taken with alcohol or certain other medications. Due to these potential risks, Flibanserin is only available through certified healthcare providers and pharmacies and patients are closely monitored.

Understanding the Nickname: “Pink Female Viagra”

Flibanserin, marketed under the brand name Addyi, has often been nicknamed the “Pink Female Viagra” by media and public. This nickname is catchy and has been effective in generating public interest, but it also oversimplifies and misrepresents the drug’s purpose and mechanism of action.

The comparison arises because both Viagra and Flibanserin are drugs aimed at addressing sexual dysfunction – Viagra for erectile dysfunction in men, and Flibanserin for hypoactive sexual desire disorder (HSDD) in women. Additionally, Viagra is often associated with the color blue due to the distinctive color of the pill, and so Flibanserin is associated with pink, playing off traditional gender color associations.

However, the workings of Viagra and Flibanserin are fundamentally different. Viagra, or sildenafil, works by increasing blood flow to the penis to help men achieve and maintain an erection. Its effect is purely physiological and it’s used on an as-needed basis before sexual activity.

On the other hand, Flibanserin targets the brain, not the genital area. It works by adjusting the balance of certain neurotransmitters in the brain (like dopamine and serotonin) to help increase sexual desire. Unlike Viagra, Flibanserin is taken daily, not just when a woman plans to engage in sexual activity, and it doesn’t work immediately but needs several weeks to take effect.

Therefore, while the nickname “Pink Female Viagra” is popular, it is important to clarify the distinction between these two drugs to avoid confusion and misunderstanding about their uses and effects.

What is Flibanserin (Addyi)?

  1. Drug Classification:

Flibanserin, marketed under the brand name Addyi, is classified as a non-hormonal prescription medication. It belongs to a class of drugs known as multifunctional serotonin agonist antagonist (MSAA), working by targeting certain serotonin receptors in the brain. Specifically, it acts as an agonist on the 5-HT1A receptors and an antagonist on the 5-HT2A receptors. By modifying the activities of these receptors, Flibanserin influences the balance of neurotransmitters (chemical messengers) involved in sexual desire.

  1. FDA Approval and History:

Flibanserin was originally developed by the German pharmaceutical company Boehringer Ingelheim as an antidepressant. However, during clinical trials, it showed little efficacy in treating depression but demonstrated a potential positive effect on sexual desire.

The drug was then repurposed to treat Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, but it faced a challenging path towards FDA approval. The FDA initially rejected Flibanserin twice, in 2010 and 2013, due to concerns about its effectiveness and side effects.

Boehringer Ingelheim then sold Flibanserin to Sprout Pharmaceuticals, which conducted additional studies and resubmitted the drug for approval. Amid ongoing debates about women’s sexual health and accusations of gender bias in sexual dysfunction drugs, the FDA approved Flibanserin in August 2015, making it the first drug approved to treat sexual desire disorders in women.

Despite its approval, Flibanserin has continued to be surrounded by controversy due to its modest effectiveness, potential side effects, and stringent usage guidelines. As of my knowledge cutoff in September 2021, it is still the only drug specifically approved for treating HSDD in women.

Flibanserin’s Mechanism of Action

  1. How It Works:

Flibanserin operates on the central nervous system, specifically targeting and influencing certain neurotransmitters in the brain. It does this by acting on serotonin receptors, working as an agonist (activator) on one type of receptor (5-HT1A) and an antagonist (blocker) on another type (5-HT2A).

  1. The Effect on Neurotransmitters:

The neurotransmitters affected by Flibanserin are primarily serotonin, dopamine, and norepinephrine, which are all thought to have a role in sexual desire and arousal.

Serotonin is a neurotransmitter that, among many other functions, can inhibit sexual activity. By acting as an antagonist on the 5-HT2A serotonin receptors, Flibanserin blocks the activity of these receptors and reduces the inhibitory effects of serotonin on sexual desire.

On the other hand, Flibanserin acts as an agonist on the 5-HT1A serotonin receptors. When activated, these receptors help increase the levels of dopamine and norepinephrine in certain parts of the brain. Both dopamine and norepinephrine are thought to promote sexual desire.

Through these actions on the serotonin receptors and the subsequent effects on dopamine and norepinephrine, Flibanserin can help to increase sexual desire in women diagnosed with hypoactive sexual desire disorder. However, it’s worth noting that the exact mechanism of action in treating HSDD is not fully understood and is still under investigation.

Applications and Benefits of Flibanserin

Primary Usage: Hypoactive Sexual Desire Disorder (HSDD)

Explaining HSDD:

Hypoactive Sexual Desire Disorder (HSDD) is a type of sexual dysfunction characterized by a persistent or recurring lack of sexual fantasies and desire for sexual activity that causes distress or interpersonal difficulty. This condition isn’t due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. It’s important to note that low sexual desire is only considered a disorder if it causes distress for the individual.

How Flibanserin Helps:

Flibanserin is specifically designed to treat premenopausal women diagnosed with HSDD. It works by affecting the balance of certain neurotransmitters in the brain that are involved in sexual desire, including dopamine, norepinephrine, and serotonin. By influencing the action of these neurotransmitters, Flibanserin may help increase sexual desire in women with HSDD.

Other Potential Applications of Flibanserin

While Flibanserin is specifically approved for treating HSDD in premenopausal women, there is ongoing research to explore other potential applications of this drug. However, as of my knowledge cut-off in September 2021, Flibanserin has not been approved for other indications. Any off-label use should be done under careful medical supervision.

Flibanserin Reviews: Real-life Experiences and Case Studies

Patient reviews and case studies of Flibanserin are diverse, reflecting individual experiences with the drug. Some women report significant improvements in their sexual desire and reduction in distress, enhancing their overall quality of life. However, others may not experience a substantial change or may experience side effects that outweigh the benefits. It’s important for each woman to discuss with her healthcare provider to weigh the potential benefits and risks before starting Flibanserin.

Flibanserin Interactions and Safety Measures

A. Common Interactions and How to Avoid Them
CYP3A4 Inhibitors: Drugs like ketoconazole and ritonavir, among others, can increase the levels of Flibanserin in the blood, leading to an increased risk of side effects. Avoid these drugs when taking Flibanserin.
CYP3A4 Inducers: Drugs such as rifampin and St. John’s Wort can decrease the levels of Flibanserin in the blood, which may reduce its effectiveness. It’s advisable to avoid these medications while on Flibanserin.
Certain CNS Depressants: Flibanserin may enhance the central nervous system depression effects of certain medications, increasing the risk of side effects like drowsiness and hypotension.
B. Precautions when Using Flibanserin
Pregnancy and Breastfeeding: Flibanserin is not recommended for use during pregnancy or breastfeeding. Always inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.
Liver Impairment: Flibanserin is contraindicated in women with significant liver impairment due to the increased risk of low blood pressure and fainting.
Low Blood Pressure and Fainting: Use of Flibanserin can lead to a drop in blood pressure and episodes of fainting, especially when used with alcohol or certain other medications. It should be taken at bedtime to reduce the risk of these side effects.
C. Interaction with Alcohol and Other Medications
Alcohol: Combining Flibanserin with alcohol can lead to severe low blood pressure and fainting. It’s advisable to avoid alcohol completely when taking Flibanserin.
Certain Other Medications: As mentioned earlier, medications that inhibit or induce CYP3A4 can interact with Flibanserin, potentially increasing side effects or reducing efficacy. Always inform your healthcare provider of any other medications or supplements you are taking.

Understanding Flibanserin Side Effects

Common Side Effects Dizziness: This is one of the most common side effects. The drug’s impact on neurotransmitters can lead to feelings of dizziness in some patients.
Nausea: Some patients report feeling nauseous when starting the medication. This side effect often decreases over time.
Fatigue: Flibanserin can cause sleepiness or fatigue, which is why it’s recommended to take it at bedtime.
Insomnia: While less common, some patients report difficulties sleeping when on Flibanserin.
Serious Side Effects Hypotension (low blood pressure): Flibanserin can cause a drop in blood pressure, which can make you feel dizzy or faint, especially when standing from a sitting or lying position.
Syncope (fainting): Some patients may experience episodes of fainting, especially when taking Flibanserin with alcohol or certain other medications.
Management of Side Effects – It’s important to discuss any side effects with your healthcare provider, who may adjust your dose or suggest other ways to manage side effects.
– Always take the medication as instructed, typically at bedtime, to help minimize the impact of side effects such as drowsiness or dizziness.
– Avoid alcohol and other substances that can enhance the drug’s side effects.
– Inform your healthcare provider of all other medications you are taking to avoid potential drug interactions.

References and Additional Resources

List of Sources Used:

  1. FDA Drug Safety Communication: FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women. U.S. Food and Drug Administration. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-treatment-hypoactive-sexual-desire-disorder-premenopausal-women
  2. Addyi (flibanserin) tablets, for oral use. U.S. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf
  3. Mayo Clinic: Hypoactive sexual desire disorder. Available from: https://www.mayoclinic.org/diseases-conditions/hypoactive-sexual-desire-disorder/symptoms-causes/syc-20374515
  4. Jaspers L, Feys F, Bramer WM, Franco OH, Leusink P, Laan ET. Efficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women: a systematic review and meta-analysis. JAMA Intern Med. 2016;176(4):453-462.

Resources for Further Information and Support:

  1. National Women’s Health Network: A Critical Look at Flibanserin (Addyi), the Female “Viagra”. Available from: https://nwhn.org/critical-look-flibanserin-addyi-female-viagra/
  2. Mayo Clinic: Women’s Health. Available from: https://www.mayoclinic.org/healthy-lifestyle/womens-health/in-depth/sexual-health/art-20047771

Contacts for Relevant Health Organizations and Helplines:

  1. The American Congress of Obstetricians and Gynecologists: www.acog.org
  2. National Sexual Violence Resource Center: www.nsvrc.org
  3. American Association of Sexuality Educators, Counselors, and Therapists: www.aasect.org
  4. International Society for Sexual Medicine: www.issm.info