The “pink pill” made for women’s sexual health, sounds almost unreal, right?
But it has come true, the FDA-approved drug is rewriting the way we talk about women’s desire.
We’re finally living in an era where women don’t need to hide, minimize, or feel ashamed of their sexual needs. For decades, sexual health revolved around men and taking a pill to enhance desire was a luxury reserved only for them. But with Addyi, often called the pink pill, women finally stepped into that conversation.
ow libido in women wasn’t seen as a treatable medical concern, it was brushed off as “stress,” “mood,” or simply “normal.” That changed in August 2015, when the FDA approved Addyi (flibanserin), the first-ever medication specifically designed to treat female sexual interest/arousal disorder (FSIAD).
It was more than a pharmaceutical milestone but was a cultural shift.
A breakthrough born not just from demand, but from decades of scientific persistence, clinical trials, and a recognition of a very real, deeply unmet need.
Female sexual interest/arousal disorder (FSIAD) was previously known as hypoactive sexual desire disorder (HSDD).
Female sexual interest/arousal disorder represents a significant health concern characterized by persistently reduced or absent sexual interest and arousal in women. According to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), diagnosis requires three or more specific symptoms lasting at least six months, including:
Reduced interest in sexual activity
Absence of sexual or erotic thoughts and fantasies
Decreased initiation of sexual activity
Lack of sexual excitement or pleasure during intimacy
Diminished sexual interest in response to erotic cues
Reduced genital or non-genital sensations during sexual activity 1
Research indicates that between 6% and 46% of premenopausal women experience symptoms of sexual desire disorders, with approximately 10% experiencing desire disorders specifically.
Studies have shown higher rates among Asian ethnicities, including Chinese and Japanese women.
Sometimes the most significant medical breakthroughs come from unexpected places. Flibanserin's journey exemplifies this perfectly, a story of scientific perseverance and serendipitous discovery.
Originally it was developed by Boehringer Ingelheim as a treatment for major depressive disorder. However, as clinical trials progressed, the medication failed to demonstrate significant efficacy in treating depression. But something remarkable emerged from those clinical trials: female participants reported an unexpected side effect “increased libido.”
Boehringer Ingelheim is a German pharmaceutical company that is research-driven and operates globally. Founded in 1885, it is the world's largest private pharmaceutical company.
The First Attempt: Lessons in Persistence
Recognizing the potential, Boehringer Ingelheim pivoted their research focus entirely. In 2009, they filed a new drug application (NDA) with the FDA for flibanserin's use in treating female hypoactive sexual desire disorder. However, the FDA denied approval. Two clinical trials had failed to show statistical improvement in the coprimary endpoint of sexual desire.
A New Drug Application (NDA) is a formal process where a company submits a detailed application to a regulatory body like the U.S. Food and Drug Administration (FDA) to request approval to market a new drug.
Then Sprout Pharmaceuticals, a company that saw beyond the initial rejection. In a bold move, Sprout purchased the rights to flibanserin, believing in both the science and the unmet medical need. They recognized that millions of women suffered from HSDD with no FDA-approved treatment options available.
They conducted additional research, refined their approach, and filed a new drug application (NDA) in 2013, demonstrating renewed commitment to bringing this treatment to women who desperately needed it. The FDA did not approve the application, citing safety concerns, and requested additional studies, including a trial examining the effects of the drug on driving ability due to its potential to cause severe drowsiness. 1
After multiple submissions and additional safety studies, Addyi received FDA approval, becoming the first drug of its kind for treating HSDD (hypoactive sexual desire disorder) in premenopausal women.
Significant regulatory changes removed the alcohol contraindication and REMS certification requirement, though important alcohol consumption guidelines remain.
Addyi has been prescribed by over 30,000 healthcare providers, demonstrating a decade of scientific commitment to product quality and safety monitoring.
The story of Addyi cannot be told without recognizing Cindy Eckert, the visionary entrepreneur who refused to let this treatment disappear. Born in Western New York in 1973, Eckert co-founded Sprout Pharmaceuticals with her husband Bob Whitehead, acquiring the rights to flibanserin from Boehringer Ingelheim.
She had previously co-founded Slate Pharmaceuticals in 2007, which focused on men's sexual health and sold for a significant sum in 2011.
But it was her work with Sprout that would make history. After the dramatic $1 billion sale to Valeant in 2015, just one day after FDA approval and subsequent re-acquisition in 2017, Eckert founded The Pink Ceiling, an investment firm dedicated to improving access to capital for female-led startups and companies delivering products for women. Through this venture and its affiliated "Pinkubator" incubator in Raleigh, North Carolina, she continues to champion women entrepreneurs and innovation in women's health.
Unlike previous attempts to address female sexual dysfunction, flibanserin operates through a unique multimodal serotonergic mechanism. The medication targets specific serotonin receptors in the central nervous system, particularly:
5-HT1A Receptor Agonism: Flibanserin shows high affinity for postsynaptic 5-HT1A receptors in the hippocampus and prefrontal cortex, influencing downstream neurotransmitter levels.
5-HT2A Receptor Antagonism: Combined with 5-HT1A activity, this antagonism helps boost dopamine levels in the mesocortical area of the prefrontal cortex.
Neurotransmitter Modulation: The drug increases dopamine and norepinephrine concentrations selectively in the prefrontal cortex while reducing serotonin levels with chronic administration.
Addyis is not a "Female Viagra": Understanding the Fundamental Difference: It is often referred to as "female Viagra," but this comparison is misleading and overlooks crucial differences in how these medications work. While a Viagra pill treats erectile dysfunction by improving blood flow to the penis, flibanserin was developed as an anti-depressant and boosts sexual desire by balancing chemicals in the brain.
Dopamine plays a crucial role in boosting sexual desire, while norepinephrine stimulates sexual arousal. Conversely, serotonin modulates sexual activity in an inhibitory fashion.
By carefully balancing these neurotransmitters, flibanserin theoretically improves sexual desire and arousal in women with FSIAD. 1
The standard dosage is 100 mg taken once daily at bedtime. This timing is critical because administration during waking hours significantly increases risks of hypotension, syncope, accidental injury, and CNS depression. 1
Healthcare providers should evaluate treatment effectiveness after eight weeks,as per FDA guidelines. If no improvement is observed, discontinuation should be considered.
Patients should observe the following alcohol consumption rules:
Wait two hours after consuming one or two standard drinks before taking Addyi at bedtime
Skip the Addyi dose entirely if three or more drinks have been consumed
A standard drink equals one 12-ounce beer, 5 ounces of wine, or 1.5 ounces of distilled spirits
As per FDA, Addyi use is contraindicated in patients with:
Concurrent alcohol consumption
Use of moderate or strong CYP3A4 inhibitors
Hepatic impairment
Hypotension and Syncope: Patients experiencing pre-syncope should immediately lie down and seek medical attention if symptoms persist.
CNS Depression: Somnolence and sedation can occur, increased when combined with other CNS depressants. Patients should avoid activities requiring alertness, including driving or operating machinery, for at least six hours after each dose.
Drug Interactions: Oral contraceptives and other weak CYP3A4 inhibitors can increase flibanserin exposure and adverse reaction incidence. Strong CYP2C19 inhibitors similarly increase exposure and associated risks.
The most frequently reported side effects (occurring in 2% or more of patients) include:
Dizziness
Somnolence
Nausea
Fatigue
Insomnia
Dry mouth
Addyi remains available through a restricted program designed to ensure appropriate use and patient safety. This program emphasizes the importance of healthcare provider education and patient counseling regarding alcohol abstinence and potential risks.
Addyi (flibanserin) requires a prescription from a certified healthcare provider and can be filled at various pharmacies.
Addyi is specifically indicated for premenopausal women with acquired, generalized HSDD characterized by low sexual desire causing marked distress or interpersonal difficulty that is not attributable to:
Co-existing medical or psychiatric conditions
Relationship problems
Medication or substance effects
Important limitations include:
Not indicated for postmenopausal women or men
Not approved for enhancing sexual performance
Requires careful patient selection and monitoring
After a decade of clinical use, Addyi continues to represent an important therapeutic option for women experiencing distressing symptoms of FSIAD. The medication's journey from an unsuccessful antidepressant to the first FDA-approved treatment for female sexual desire disorder illustrates the importance of recognizing and addressing unmet needs in women's sexual health.
What are Addyi tablets used for?
Addyi (flibanserin) is used to treat female sexual interest/arousal disorder (FSIAD) in premenopausal women who experience low sexual desire.
How long does Addyi take to work?
Clinical trials show that improvements in sexual desire, satisfying sexual events, and related distress can begin as early as 4 weeks. However, the full evaluation should be done in 8 weeks. If no improvement is seen after 8 weeks, Addyi should be discontinued.
What happens if a woman takes Addyi?
Addyi works by adjusting neurotransmitters in the brain, increasing dopamine and norepinephrine (which promote desire and arousal) and reducing serotonin (which can inhibit sexual drive).
How expensive is Addyi?
With insurance: as low as $20 per month
Without insurance (cash pay): approximately $199 per month
