New Non-Hormonal Treatment Offers Relief from Menopausal Hot Flashes — With Safety Caveats

What Happened

In May 2023, the U.S. Food and Drug Administration (FDA) approved fezolinetant (brand name Veozah), the first non-hormonal medication in a new class called NK₃ receptor antagonists. It’s designed specifically to reduce moderate to severe hot flashes in menopausal women. The European Union followed with its own approval in December 2023, marking a global shift in treatment options.

However, in September 2024, the FDA issued a new safety warning after reports of rare but serious cases of liver injury among users, prompting updated guidance for monitoring.

Why It Matters

For decades, hormone therapy (HT) has been the most effective option for managing hot flashes, but not every woman can—or wants to—take hormones. Fezolinetant represents a breakthrough by offering a non-hormonal alternative backed by clinical trial data, signaling progress toward personalized menopause care.

Still, the added liver safety warning reminds both doctors and patients that no treatment is risk-free, and ongoing vigilance is essential.

What This Means for Women in Perimenopause & Menopause

If hot flashes are disrupting your sleep, mood, or daily life—and you can’t or prefer not to take hormones—fezolinetant may provide an option. Many women report meaningful relief within weeks.

But, because of the liver injury warning, doctors now recommend baseline and ongoing liver function tests while taking the drug. This means that women who choose this therapy should expect regular blood work and monitoring.

Access & Availability

U.S.: FDA-approved in May 2023; available by prescription.
EU: Approved in December 2023.
Other regions: Still under regulatory review in some countries.

Benefits & Risks

Benefits

Significantly reduces the frequency and severity of hot flashes.
Works without hormones, making it a viable option for women who cannot take estrogen.
May improve sleep and overall quality of life by easing disruptive symptoms.

Risks

Rare but serious liver injury (requires ongoing monitoring).
Common side effects reported: headache, abdominal pain, diarrhea, and insomnia.
Limited long-term safety data compared to established hormone therapies.

Next Steps / What to Watch For

Post-market safety data will shape how widely fezolinetant is prescribed.
Researchers are studying whether similar non-hormonal drugs could expand treatment options.
The FDA and EMA may issue updated guidance as more safety information emerges.

What This Means for Your Midlife Health

Fezolinetant signals hope for women who want more non-hormonal solutions for menopause care. It’s proof that research is expanding beyond hormones, but it also highlights why careful, informed decision-making with your doctor is so important. As more data comes in, you’ll know whether this medication—or future ones in its class—could be right for you.