For many women, waking up drenched in sweat or suddenly feeling overheated is all too familiar. Hot flashes and night sweats are a hallmark of menopause, affecting more than 80% of women. It’s more than a minor inconvenience; hot flashes and night sweats can seriously disrupt sleep, focus and mood and the symptoms can last for more than a decade.
Hormone replacement therapy (HRT) and a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) have been the best options to find relief. But these medications aren’t the right choice for everyone, especially women with a history of breast cancer, blood clots or other health risks. Nonhormonal options have existed, but they’ve been hit or miss.
The U.S. Food and Drug Administration (FDA) recently approved a medication called Lynkuet (elinzanetant). It’s a new nonhormonal medication designed to treat hot flashes and night sweats, and clinical trials showed that about 80% of women saw their hot flashes cut in half after 26 weeks; many women noticed a difference within the first week.
To understand what makes this medication different — and what women can do right now to manage symptoms — we spoke with Novant Health gynecologist Dr. Claire Bowles.
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Why are hot flashes and night sweats an issue, and what can women do to manage them?
When estrogen levels drop during perimenopause and menopause, your body can overreact to tiny changes in temperature and trigger a hot flash. It causes a sudden feeling of heat that starts in your core and spreads up through your face, neck and chest and makes you feel flushed and sweaty. Sometimes they are also associated heart palpitations and other physical symptoms. When a hot flash happens during sleep, it’s called a night sweat.
Women often try lifestyle changes like keeping the bedroom cool, cutting back on caffeine and alcohol and managing stress to cope with hot flashes.
When lifestyle changes are not enough, what medications are available?
Hormone therapy is still the gold standard. It’s very effective at calming hot flashes because it replaces the estrogen your body’s missing. But not everyone can or wants to take hormones. Women who have hormone-sensitive cancers or a history of blood clots or other complex medical histories might not be candidates for hormone replacement and will need non-hormonal options.
The FDA recently removed the “black box” warning on hormone replacement products. What does this mean?
The change reflects decades of additional data showing that the earlier concerns about the risks of HRT do not apply to most healthy, recently menopausal women. New evidence shows that for most women in their 40s and 50s, the risks from modern hormone therapy remain very low.
Removing the boxed warning reduces fear and stigma, allowing patients and clinicians to have more informed, individualized discussions about HRT for hot flashes and night sweats. (A black box warning is the FDA’s strongest alert for prescription drugs that have the potential to cause death or serious injury. It appears in a black-bordered box on the drug’s prescribing information.)
What makes this new drug, Lynkuet, different?
Lynkuet is exciting because it’s a non-hormonal oral medication that targets certain brain receptors that control body temperature, so it goes straight to the source of the problem.
In studies, women saw a big improvement quickly. There was a 38% reduction in daily hot flashes after one week and 80% of women had their hot flashes cut in half by week 26. It also seemed to help women sleep better, which is a huge bonus because night sweats can really disrupt sleep.
Are there any side effects or safety issues women should know about?
The most common side effects were mild things like headache or nausea.
There was a small risk of changes in liver function, so doctors will usually check liver labs before starting and once after. With some of the older drugs, we check liver function when you start, once a month for three months and every three months for the rest of the year, so there is a lot less testing with Lynkuet.
Do you think this will be a game changer for patients?
I think it’s a big step forward. We’ve needed more nonhormonal options for a long time. Hormone therapy is great for many women but it’s not for everyone. Having an effective non-hormonal option gives us more ways to personalize care.
The biggest challenges now will be cost and access. New medications can be pricey at first, but companies usually roll out assistance programs. I’m hopeful this will become a realistic option for more women soon.
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