Key Takeaways
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Elinzanetant, a new drug to treat moderate-to-severe hot flashes and night sweats, has received federal approval
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The drug is a nonhormonal menopause treatment that works in the brain and appears to help reduce sleep disturbances
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In clinical trials, 80% of patients saw a 50% drop in hot flash frequency after 26 weeks
MONDAY, Oct. 27, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has approved a new nonhormonal treatment to help women manage menopause symptoms such as hot flashes and night sweats.
Elinzanetant (Lynkuet), a once-daily pill, is expected to be available within weeks.
These uncomfortable symptoms affect up to 80% of women during menopause and can last a decade or more, significantly affecting quality of life and sleep, according to The Menopause Society.
For women seeking treatment who cannot safely take hormone therapy or are uncomfortable with it, this new option is another tool in the toolbox.
“To have nonhormonal options for them is tremendously important,” Dr. JoAnn Manson, an endocrinologist and professor at Harvard Medical School in Boston, told The New York Times.
Elinzanetant is the first FDA-approved drug that works by targeting and blocking two specific types of receptors in the brain.
These receptors are involved in the body’s temperature regulation system. By blocking them, the drug helps stabilize a woman’s internal thermostat, reducing the frequency and severity of hot flashes and night sweats.
The manufacturer, Bayer, says the once-daily pill will be available to women in November.
A similar nonhormonal drug, fezolinetant (Veozah), blocks one receptor.
Experts believe the additional receptor blocked by elinzanetant may also regulate sleep, potentially treating sleep disturbances caused by menopause.
Dr. JoAnn Pinkerton, a trial investigator and professor at the University of Virginia Health System in Charlottesville, told The New York Times that patients in the clinical trials experienced significantly less sleep disturbance in addition to fewer hot flashes.
She said the clinical trials, which focused on postmenopausal women aged 40 to 65 with persistent hot flashes, showed:
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Symptom improvement began just one week after patients started the treatment.
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At 12 weeks, more than 70% of women reported at least a 50% drop in the frequency of their hot flashes. This improvement continued, with over 80% reporting the same reduction at 26 weeks.
Common side effects reported included headache, fatigue and joint pain.
Since a few patients showed elevated liver enzyme levels, Lynkuet will not be recommended for women with known liver issues. As with fezolinetant, patients taking elinzanetant will be advised to have regular liver function tests.
Dr. Jewel Kling, a menopause expert at the Mayo Clinic, said she was relieved to see “no clear sign of liver toxicity in the trials of elinzanetant.”
She cautioned, however, that rare side effects sometimes appear only once a drug is widely available.
More information
The Mayo Clinic has more information on menopause treatments.
SOURCES: The New York Times, Oct. 24, 2025; Bayer, news release, Oct. 24, 2025
What This Means For You
If you are struggling with severe hot flashes and night sweats, especially if you have been advised against hormone therapy, ask your health care provider whether a nonhormonal treatment is right for you.