Published November 14, 2025
FDA Approves Nonhormonal Treatment for Menopausal Hot Flashes
The US Food and Drug Administration (FDA) recently approved elinzanetant, marketed as Lynkuet, for moderate to severe hot flashes due to menopause, the third FDA-approved nonhormonal treatment option for vasomotor symptoms, which include hot flashes and night sweats.
Elinzanetant blocks 2 types of neurokinins, molecules involved in the brain’s temperature control system, to alleviate hot flashes. An invited commentary on one of the drug's clinical trials and a recent viewpoint highlight the value of nonhormonal options for menopause care. Results from a randomized clinical trial of year-long elinzanetant use in 628 postmenopausal women experiencing vasomotor symptoms were recently published in JAMA Internal Medicine. At 12 weeks, women taking elinzanetant experienced a daily reduction of 5.4 moderate to severe hot flashes compared with 3.5 in the placebo group, a 74% vs 47% decrease from baseline. Elinzanetant use was also associated with improved sleep and quality of life.
Two trials previously published in JAMA showed significant improvements in vasomotor symptoms as early as at 1 and 4 weeks of treatment. Elinzanetant is expected to be available in capsule form in November. The FDA advised close monitoring because the drug may cause increased liver enzyme levels.
Vasomotor symptoms (VMS) and sleep disturbances are common menopause symptoms and adversely affect menopause-related quality of life. Menopause occurs between ages 45 and 56 years for 90% of women in the US. Growing evidence suggests that VMS and primary insomnia in menopause are driven, at least in part, by the effect of declining estrogen levels on the thermoregulatory function of the hypothalamus and hypothalamic neurokinin neurons, which is a target of Elinzanetant.