[5 min read]
In this article:
- The U.S. Food and Drug Administration (FDA) recently approved a new non-hormonal menopause drug for patients who are not eligible for hormone replacement therapy.
- The FDA also removed a "black box" warning from hormone replacement therapy (HRT), making HRT expanding availablity for more patients who are without underlying health conditions, which include a history of clotting disorders, certain cancers and cardiovasuclar events.
- Providence Swedish clinicians and physicians are committed to ensuring that women are aware of all their options for menopause care and helping patients make the most educated decisions about their care.
Menopause marks a major transition in a woman’s life, bringing a host of physical and emotional changes. Menopause typically occurs between the ages of 45 and 55. In the United States alone, nearly 1.3 million women enter menopause each year. The most common—and often most disruptive—symptoms are hot flashes and night sweats. It’s estimated that up to 75% of menopausal women experience hot flashes, with about 20% reporting severe symptoms that impact daily life. While hormone replacement therapy (HRT) has long been the go-to treatment, it isn’t suitable for everyone.
Last November, the U.S. Food and Drug Administration (FDA) approved a new non-hormonal menopause drug, elinzanatant, which is sold under the brand name Lynkuet, which offers relief to women in menopause who are not eligible for hormone replacement therapy (HRT). Around the same time, officials revised long-standing HRT guidance, making it available to more women. Both of these advances are big news for women seeking relief from menopause symptoms and better options to support the hormone changes that come with menopause. To learn more, we spoke with Elizabeth Skelly, ARNP, a women’s health and menopause expert at the Swedish Gynecology Specialty Center in First Hill.
How Lynkuet differs from other menopause drugs
“Lynkuet is used to treat vasomotor symptoms associated with menopause, which include hot flashes and night sweats,” says Skelly. “It belongs to the medication class of neurokinin one and neurokinin 3 receptor blockers—which essentially target pathways to calm the internal thermostat. The relief that many women are getting can be pretty life-changing, especially for patients who have not been getting relief with what’s available to them.”
What sets Lynkuet apart from other menopause treatments is how it works in the body. While older non-hormonal options like antidepressants or gabapentin have been used “off-label” to treat hot flashes, they were not specifically developed for menopause and may come with unwanted side effects or limited effectiveness. Lynkuet does not contain estrogen or progesterone. Instead, it targets pathways in the brain that regulate body temperature, helping reduce the frequency and severity of hot flashes and night sweats, making it an excellent option for women who are not candidates for hormone therapy.
The drug does have some side effects, advises Skelly.
“The most common side effects of Lynkuet (elinzanetant) are fatigue, dizziness, and drowsiness; for women who struggle with sleep disturbance, these effects may actually be beneficial by helping to improve sleep, a common concern during perimenopause and menopause.”
“I’m very excited about these new developments, and many of my colleagues are as well, particularly because women’s health has historically been underrepresented,” says Skelly. “For a long time, women’s voices and experiences were largely overlooked. With generational change, we’re now able to speak more openly about our concerns and symptoms. In the past, perimenopause and menopause weren’t widely discussed, nor were treatment options. Advances like Lynkuet are encouraging because they expand our choices beyond hormone therapy when needed.”
Taking hormone therapy: removing the black box warning
Hormone replacement therapy (HRT) has helped millions manage menopause symptoms by replacing hormones the body no longer produces. And like most treatments for any condition, HRT is not suitable for everyone. But for years, HRT products carried a prominent “black box warning”—the FDA’s strictest safety alert—due to concerns about increased risks of breast cancer, heart disease, stroke, and blood clots. This warning led many women and doctors to avoid HRT, even when it might have been safe and beneficial.
Recent studies have clarified that the risks are lower than previously thought, especially for younger women or those starting HRT close to menopause. In November 2025, the FDA announced that it was removing the black box warning from HRT for women without underlying risk factors. This change allows more women to consider HRT as a safe option and encourages open discussions between patients and healthcare providers.
“For the past 20 to 30 years, hormone therapy has been portrayed in a very negative way.That has done women a disservice,” says Skelly. "Menopause and HRT were long treated as something to fear, and now we’re working to change that narrative. Women are owed an apology, and in our practice we make it a priority to educate them about the full range of options available. It’s something we focus on every day, and it’s what I love most about our work.”
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Information for patients and visitors
Related resources
You can thrive, not just survive, during perimenopause and menopause
Perimenopause and menopause: myths, reality and how to cope
New Swedish Gynecology Specialty Center brings a host of women’s health services under one roof
When menopause and breast cancer treatment overlap, supportive, experienced care teams help patients
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