- On December 15, 2025, the U.S. FDA approved Addyi (flibanserin) for the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women under the age of 65.
- Addyi was previously approved in 2015 for the treatment of HSDD in premenopausal women.
- Past research shows that between 40-55% of people advancing through menopause experience low sexual desire, and about 9% of postmenopausal women have HSDD.
Addyi was previously approved in 2015 for the treatment of HSDD in premenopausal women. Premenopause or “before” menopause refers to the reproductive time in a cisgender woman’s life when they have regular menstrual cycles.
Postmenopause refers to the time period after the person finishes menopause and no longer has a menstrual cycle. The majority of people start menopause between the ages of 49 and 52.
While people can experience HSDD at any age, it is not uncommon to experience a low libido during menopause and postmenopause. Past research shows that between 40-55% of women advancing through menopause experience low sexual desire, and about 9% of postmenopausal women have HSDD.
With the expanded approval to postmenopausal women under 65, Medical News Today spoke with three women’s health experts to find out more about how Addyi works, its side effects, what does this approval mean for menopausal women, and any non-medication alternatives they suggest for low libido.
Addyi is a prescription medication manufactured by Sprout Pharmaceuticals.
“Addyi is a non hormonal medication that works on neurotransmitters in the brain to help regulate mood and increase sex drive,” Susan Marie Pacana, MD, minimally invasive gynecologic surgeon and OB/GYN at Hackensack Meridian Jersey Shore University Medical Center in New Jersey, told MNT.
“Addyi is a medication for women that, according to the manufacturer, increases sexual desire,” Prudence Hall, MD, an OB/GYN in private practice in Santa Monica, CA, and author of Radiant Again & Forever: Overcome Menopause & Restore Your Radiance, added.
How Addyi boosts sex drive
“After taking it for a month, dopamine and serotonin levels are apparently enhanced, which supposedly increases sexual desire.”
— Prudence Hall, MD
With the expanded approval for postmenopausal women under the age of 65, G. Thomas Ruiz, MD, a board certified OB/GYN at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, told MNT that Addyi could now help a greater number of women.
“The group of women where I get the biggest complaints of decreased libido is in the 50 to 60 year old age bracket, so potentially this could be a very important medication for them,” Ruiz added.
Pacana, who is also a Menopause Society Certified Practitioner, commented that the lack of medications for low libido has been a long-standing issue, but the new FDA approval for this treatment up to age 65 is a major step forward.
“Women of all ages present to our office with complaints of low sex drive that affect their relationships, self-esteem, and body image,” she explained. “It often is accompanied by feelings of shame, frustration and guilt when women are unable to meet their partner’s sexual expectations.”
Drug to be covered by insurance
“Previously, I could prescribe it off-label for postmenopausal women, but they were unfairly denied insurance coverage. Now, with this official approval, we can finally expect insurers to cover this necessary treatment for a wider population of women.”
— Susan Marie Pacana, MD
Like all medications, Addyi has known potential side effects, including:
- Constipation
- Dizziness
- Dry mouth
- Headache
- Nausea
- Sleepiness or insomnia
- Stomach or back pain
- Tiredness
Ruiz said it would be very helpful for the drug company to issue a simple handout of all the “do’s and don’ts” associated with Addyi.
“They’ve got to make it as least confusing for patients to use as possible, so a simple do’s and don’ts information sheet would be useful,” he detailed. “And that would be useful for providers.”
For women who may not want to take medication, what other things can they do to help with a low libido? For perimenopausal and menopausal women, Hall said optimizing their declining and absent hormones is extremely effective.
“Over the 40 years of my work in this area, I commonly see women’s sexuality bloom into a renaissance of youthful passion,” she explained.
One alternative: estradiol
“Estradiol is extremely effective for this, with the estradiol patch and compounded cream being my top two choices. When testosterone is low and replaced to youthful levels, orgasms become more easily accessed and are stronger. It is not uncommon for women to tell me that their desire is completely gone and that they can’t even have an orgasm.”
— Prudence Hall, MD
“Also when thyroid and adrenal stress hormones are precisely optimized, energy is increased and depression recedes. Women report that their sexuality returns to youthful levels causing a resurgence of intimacy and contentment with themselves and their relationships,” Hall continued.
‘Scheduling’ sex may help
Ruiz said that sometimes a low libido comes down to a lack of a female patient’s understanding of how their body functions sexually, and how to communicate it to her partner.
Spontaneous vs. responsive desire
“In terms of the first stage of sexual activity, for men arousal is instantaneous. For women, [i]t’s a little bit more diffused and not as direct, so that arousal time may take 20 to 30 minutes.”
— G. Thomas Ruiz, MD
“Scheduling time for intimacy where that is the primary goal, things like that are helpful. Common activities where they’re together with their partner. Foreplay may take all day — it’s not a crazy thing to think about. And of course a good relationship with your partner — if you don’t have a good relationship with your partner, there’s not going to be a sex drive,” Ruiz explained.
“I also will also encourage women to practice with self stimulation so that they understand how their body works and they communicate that to their partner,” he added. “And that actually works for menopausal women as well.”
