Historic First in Women's Sexual Health: FDA Grants Approval for Addyi® (flibanserin) in Postmenopausal Women

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Dec 15, 2025, 11:05 ET

Addyi, the first and only FDA-approved pill clinically proven to treat frustrating low sexual desire in women, is now approved for use in women who have gone through menopause

RALEIGH, N.C., Dec. 15, 2025 /PRNewswire/ -- Sprout Pharmaceuticals today announced a monumental milestone for women's health: the U.S. Food and Drug Administration (FDA) has approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years. This long-awaited decision closes a gap in care for millions of postmenopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA.

Addyi® (flibanserin) is the #1 prescribed treatment for Hypoactive Sexual Desire Disorder (HSDD).

"This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized," said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals. "Over the years, we've pushed for the science to speak louder than the stigma — and today's approval shows how far we've come. I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life."

The expanded approval of Addyi follows the FDA's Priority Review designation announced earlier this year, a status reserved for drugs that represent meaningful improvements in the treatment for serious unmet medical needs. This designation underscores the Agency's increasing commitment to addressing long-standing gaps in women's health and ensuring timely access to evidence-based care.

"This is a major shift in expanding awareness and access to treatment for HSDD — a condition that is both common and profoundly undertreated— and we're grateful that the FDA has acknowledged the importance of closing this gap in women's sexual healthcare," Eckert added.

Clinicians who treat women with HSDD celebrated the Agency's decision, including those who witnessed the original milestone a decade ago.

"I was in the room a decade ago when Addyi became the historic first for women's sexual health, and I have been waiting for this moment ever since," said Dr. Rachel Rubin, urologist and sexual medicine specialist. "So many of my postmenopausal patients have carried the weight of frustrating low sexual desire with no FDA-approved option to turn to. Today's decision finally includes them. It's a critical acknowledgment that their pleasure, their wellbeing, and their quality of life matter — and that science-backed care should be available to every woman, at every stage of her life."

"Menopause does not mark the end of a woman's sexuality but for too long, medicine has treated it that way," said Dr. Mary Claire Haver, OB-GYN and leading menopause expert. "This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire. Expanding Addyi's approval is historic in validating women's experiences and ensuring that millions of women suffering have real choices when it comes to their sexual health."

Supported by the largest and most rigorous clinical trials ever conducted in women's sexual health, Addyi first received FDA approval in 2015 for premenopausal women. Its established safety and efficacy profile has been reaffirmed globally: in 2021, Health Canada approved Addyi for expanded use in postmenopausal women, paving the way for today's milestone in the United States.

With this expanded approval, Addyi becomes the first and only treatment of its kind for women <65 years marking a defining moment in the pursuit of sexual-health equity and reinforcing the essential truth that women deserve comprehensive, evidence-based care throughout their entire lives.

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About Sprout Pharmaceuticals
Sprout Pharmaceuticals is leading a revolution in women's health, pioneering innovative treatments that address long-overlooked needs. With the launch of Addyi, the first and only FDA-approved pill to treat low sexual desire (HSDD), Sprout helped shift the conversation around women's sexual wellness. The company remains committed to advancing science, expanding access, and advocating for the care women deserve.

About Addyi ® (flibanserin)
Addyi is the first and only FDA-approved pill to treat hypoactive sexual desire disorder (HSDD) in women <65. Addyi is a non-hormonal medication, prescribed by over 30,000 U.S. healthcare professionals and growing. Addyi works on key neurotransmitters that affect sexual response. Before taking Addyi, you should consult with your doctor. Learn more at addyi.com

About Hypoactive Sexual Desire Disorder (HSDD)
Hypoactive Sexual Desire Disorder (HSDD), also known as frustrating low libido, is a persistent lack of sexual interest or desire. It is the most common form of sexual dysfunction in women, impacting an estimated 40% of women according to the Mayo Clinic.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ADDYI?
Your risk of severe low blood pressure and fainting (loss of consciousness) is increased:

if you drink alcohol close to the time you take your ADDYI dose,
if you take ADDYI with certain medicines, or
if you have liver problems and you take ADDYI.

To lower your risk of low blood pressure and fainting (loss of consciousness):

Do not drink alcohol close to the time you take your ADDYI dose

Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime.
Skip your ADDYI dose if you drink 3 or more standard alcoholic drinks that evening.

After taking ADDYI at bedtime do not drink alcohol until the following day.

Examples of 1 standard alcoholic drink include:

one 12-ounce regular beer
5 ounces of wine
1.5 ounces of distilled spirits or shot

Tell your doctor about other medicines you take. Do not take or start taking any prescription or over-the-counter medicines, or herbal supplements without first talking to your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI.

Do not take ADDYI if you have liver problems.

If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you feel like you could faint (lose consciousness). If you faint, tell your doctor as soon as you can.

Who should not take ADDYI?
Do not take ADDYI if you:

take certain medicines. Taking ADDYI with certain other medicines can increase the amount of ADDYI in your blood and cause severe low blood pressure, fainting (loss of consciousness), and sleepiness.
Do not take ADDYI if you are taking any of the following medicines:
Certain medicines used to treat HIV-1 infection

Certain medicines that you take by mouth used to treat fungal infections
Certain antibiotics
Certain medicines used to treat Hepatitis C infection
Certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems
Nefazodone: a medicine used to treat depression

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above. These are examples of the medicines that you should not take if you are taking ADDYI. Tell your doctor about all the medicines you take before you start taking ADDYI
have liver problems
are allergic to flibanserin or any of the ingredients in ADDYI. See Medication Guide for the full list of ingredients.

What should I tell my doctor before taking ADDYI?
Before you take ADDYI, tell your doctor about all of your medical conditions, including if you:

drink alcohol, use drugs, or have a history of alcohol or drug abuse
have ever had depression or other mental health problems
have low blood pressure or a medical condition that can cause low blood pressure
are pregnant or plan to become pregnant. It is not known if ADDYI will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ADDYI passes into your breast milk. You and your doctor should decide if you will take ADDYI or breastfeed. You should not do both.

Tell your doctor if you have had an allergic reaction such as hives, itching, or trouble breathing during or after receiving a dose of ADDYI.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADDYI can affect the way other medicines work, and other medicines can affect the way ADDYI works, and can cause serious side effects.

What should I avoid while taking ADDYI?

Do not drink alcohol close to the time you take your ADDYI dose because this increases your risk of severe low blood pressure and fainting (loss of consciousness).
Do not drive, operate machinery, or do things that require clear thinking until at least 6 hours after you take ADDYI and until you know how ADDYI affects you.
Do not drink grapefruit juice if you take ADDYI. Drinking grapefruit juice during your treatment with ADDYI increases your risk of severe low blood pressure and fainting (loss of consciousness).
You should not take the herbal supplements St. John's Wort, ginkgo, or resveratrol or certain over-the-counter medicines such as cimetidine until you talk to your doctor. Taking ADDYI with these herbal supplements and over-the-counter medicines may increase your risk of low blood pressure, fainting (loss of consciousness), and sleepiness.

What are the possible side effects of ADDYI?
ADDYI can cause serious side effects, including:

Sleepiness is a common side effect of ADDYI and can be serious. Taking ADDYI can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements.
Low blood pressure and fainting (loss of consciousness) can happen when you take ADDYI even if you do not drink alcohol or take other medicines or herbal supplements. Your risk of low blood pressure and fainting (loss of consciousness) is increased if ADDYI is taken during waking hours, if you drink alcohol within 2 hours of taking ADDYI, or if you take certain medicines or herbal supplements.

The most common side effects of ADDYI include:

Dizziness
Difficulty falling asleep or staying asleep
Nausea
Dry mouth
Tiredness

These are not all of the possible side effects of ADDYI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information, including Boxed Warning regarding severe low blood pressure and fainting in certain settings, and Medication Guide at addyi.com/pi.
This information does not take the place of talking with your doctor.

INDICATION

What is ADDYI (add-ee) (flibanserin) Tablets?
ADDYI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women <65 years of age who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to: