Non-hormonal menopausal medication improves mood and hot flashes

Fezolinetant, an FDA-approved non-hormone treatment for menopause, improved hot flashes, depression, and anxiety in a real-world study, according to industry-sponsored research presented Sunday at ENDO 2026 in Chicago, Ill. The OPTION-VMS study indicates that the medication’s benefits in a general population mirror results seen in restrictive clinical trials.

How does fezolinetant affect menopause symptoms?

In a group of 201 women using fezolinetant, hot flashes and night sweats improved significantly from pre-treatment through the 4, 8, and 12-week marks. Depressive and anxiety symptoms also showed significant improvement as early as 4 weeks, continuing through 12 weeks.

The study included 656 women between the ages of 40 and 75 who suffered from bothersome menopausal vasomotor symptoms. Researchers tracked changes in vasomotor symptoms over 12 weeks and monitored mood changes at 4, 8, and 12 weeks.

Did You Know? Hot flashes are a common symptom of menopause experienced by approximately 80% of women.

Why are real-world study results significant?

Clinical trials often use restrictive enrollment criteria, meaning participants are generally healthier than the general population, according to Pauline M. Maki, Ph.D. Maki is a professor of psychiatry, psychology, and OB/GYN at the University of Illinois Chicago College of Medicine.

Maki stated that demonstrating non-hormonal treatments work in the real world provides reassurance to women that effective solutions exist. She noted that fezolinetant plays an important role as an FDA-approved non-hormonal option.

Expert Insight: The transition from controlled clinical settings to real-world data is critical for establishing how a drug performs across a diverse patient base. By confirming that fezolinetant maintains its efficacy outside of strict trial parameters, providers may have more confidence in prescribing it to women with varied health profiles.

What other non-hormone treatments were tested?

The study also tracked women using other non-hormone therapies, including SSRIs/SNRIs (n=329) and medications such as gabapentin and oxybutynin (n=126). These participants also experienced improvements in anxiety and depressive symptoms from baseline to 4, 8, and 12 weeks.

Prof. Pauline Maki – Menopause and Cognition

What may happen next for menopause care?

The findings could lead to a broader adoption of non-hormonal therapies for women who cannot or choose not to use hormone treatments. This data may also encourage clinicians to monitor both physical vasomotor symptoms and psychological mood changes when prescribing these medications.

Further analysis of the ongoing OPTION-VMS study may provide more data on the long-term effects of these treatments on sleep and mood.

Frequently Asked Questions

Who was included in the OPTION-VMS study?
The study included 656 women ages 40 to 75 who experienced bothersome menopausal vasomotor symptoms.

How quickly did fezolinetant improve mood symptoms?
According to the research, depressive and anxiety symptoms improved as early as 4 weeks and continued through 12 weeks.

What other medications were compared in this research?
Researchers looked at fezolinetant alongside SSRIs/SNRIs and other non-hormone therapies, specifically gabapentin and oxybutynin.

How do you feel about the availability of non-hormonal options for managing menopause symptoms?