Study Finds Menopause Drug Relieves Hot Flashes, Improves Sleep

The new medicine could expand options for women who can’t take hormonal therapies

Kristen Fischer,

AARP

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Published October 01, 2025

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Women who experience hot flashes and night sweats — two of the most common symptoms of menopause — could soon have a new, nonhormonal option for relief.

A study published Sept. 8 in the journal JAMA Internal Medicine found that women who took the experimental medication elinzanetant saw a 74 percent reduction in daily moderate-to-severe hot flashes over a 12-week span, compared to a 47 percent reduction in those who took a placebo. The U.S. Food and Drug Administration (FDA) is considering the medication’s approval, according to Bayer, the drug’s manufacturer.

“If approved, elinzanetant could offer relief to women who cannot take estrogen-based treatments due to medical contraindications, prefer a nonhormonal option and who struggle with disruptive hot flashes that interfere with their sleep, work or daily life,” says Dr. JoAnn V. Pinkerton, a researcher on the study and the Mamie A. Jessup professor of obstetrics and gynecology at UVA Health in Charlottesville, Virginia.

Hot flashes and night sweats are vasomotor symptoms, which are caused by diminishing estrogen levels that affect body temperature during menopause. As estrogen levels decline with menopause (or endocrine therapy for breast cancer), neurons involved in temperature regulation become hyperactive, Pinkerton explains. Elinzanetant targets those neurons.

Menopause usually occurs between the ages of 45 and 55. It can cause sudden hot flashes, accompanied by sweating, flushing and chills. Hot flashes can impact sleep and daily routines.

Evaluating the drug

For this latest study, researchers tested elinzanetant in 313 postmenopausal women ages 40 to 65 who wanted to treat their moderate-to-severe vasomotor symptoms. Additionally, 315 women received a placebo. All study participants took the pills for 52 weeks.

Women on the medication had fewer and less severe hot flashes compared with those on the placebo. Those taking elinzanetant also had fewer sleep disturbances and reported better mood.

Unlike hormone therapy, elinzanetant does not improve the progressive vaginal changes seen following menopause. It also doesn’t improve bone density, but the medication didn’t negatively affect it, either. The researchers noted only age-expected declines in bone density.

Another option for treating menopause symptoms

Elinzanetant is similar to fezolinetant (Veozah), a nonhormonal hot-flash treatment approved by the FDA in 2023. While both drugs target the NK-3 receptor, elinzanetant also blocks the NK-1 receptor, which researchers say may play a role in insomnia. That’s what gives elinzanetant a broader benefit, Pinkerton says.

An older drug, paroxetine (Brisdelle), is also FDA-approved to treat hot flashes.

Another perk of elinzanetant is that it doesn’t contain estrogen or progesterone like hormone replacement therapy (HRT) does. HRT is not recommended for those who have had breast cancer because of concerns about the cancer returning. If approved, Pinkerton says, elinzanetant will “help a large number of women who have otherwise not been helped.”

For example, a study published in June in The New England Journal of Medicine found that elinzanetant reduced the number of hot flashes and improved sleep in women with, or trying to prevent, breast cancer who were taking hormonal therapy and experienced vasomotor symptoms as a result.

It could also help other women who are not candidates for hormone therapy, Pinkerton says, including those with prior estrogen-sensitive cancers, blood clots, migraine with aura, significant endometriosis, large fibroids and an elevated risk of breast cancer. It also may be good for people who do not want to take hormone therapy or are ready to discontinue it.

What’s more, women with a history of heart attack could be candidates for elinzanetant, since hormone therapy after a heart attack is generally not recommended, says Dr. Holly N. Thomas, an assistant professor at the University of Pittsburgh who focuses on menopause.

Though there aren’t any direct head-to-head studies comparing fezolinetant and elinzanetant, they provide about 75 to 80 percent symptom improvement — significantly better than other nonhormonal treatments that typically show a 40 to 60 percent improvement, Pinkerton says.

Though many women who can’t take estrogen may benefit from elinzanetant, doctors still need to discuss all options for treatment, including the risks and benefits of any medication or therapy, says Dr. Donna Shoupe, a professor of obstetrics and gynecology at the Keck School of Medicine of the University of Southern California. Shoupe points out that estrogen replacement therapy provides more than hot-flash relief; it may also benefit your bones, brain, heart, skin and more.

Women using strong CYP3A4 inhibitors, such as the antifungal medication itraconazole, and individuals who may require dose reduction with moderate CYP3A4 inhibitors, such as the antibiotic erythromycin, should not take elinzanetant, Pinkerton says.

What’s next?

In another trial, researchers are testing how well elinzanetant reduces sleep disturbances in women going through menopause, Pinkerton says.

Many women are bothered by sleep disruption, so this may be a good option for them, Thomas adds.

Elinzanetant is already approved in the United Kingdom and Canada under the brand name Lynkuet. If it’s approved in the U.S. by the end of the year, Pinkerton estimates it could be available to consumers by May 2026.

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Kristen Fischer is a contributing writer at AARP based at the Jersey Shore. She has also written for Health, WebMD, and McKnights and is the author of Zoo Zen: A Yoga Story for Kids.