Fezolinetant Linked to 2.6 Fewer Nighttime Awakenings in Women With Menopausal VMS

Women experiencing menopause prescribed fezolinetant (Veozah; Astellas) for vasomotor symptoms (VMS) had a mean of 2.6 fewer nighttime awakenings from baseline at week 12 in a preliminary analysis of the phase 4 OPTION-VMS study. Both patient-reported and wearable-measured sleep outcomes improved, along with the study’s primary measure of how bothersome hot flashes and night sweats were, according to findings presented at the 2026 International Menopause Society World Congress on Menopause.¹

The observational study followed women aged 40 to 75 years with confirmed menopausal VMS who were prescribed nonhormonal treatment during routine care. Options included fezolinetant 45 mg, selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors, gabapentin, and oxybutynin. Investigators measured changes from baseline within treatment groups; the study was not designed to compare the therapies with one another.¹

Bothersome VMS and Sleep Measures Improved by Week 4

Among women treated with fezolinetant, scores on the Menopause-Specific Quality of Life questionnaire VMS domain improved at weeks 4, 8, and 12 (P < .001 at each assessment). Astellas said the reductions exceeded the threshold for a minimal clinically important difference. The week 12 change was the study’s primary endpoint.¹

Patient-reported sleep disturbance, measured with the PROMIS Sleep Disturbance Short Form 8b, also improved at weeks 4, 8, and 12 (P<.001). Mean scores moved from the mild sleep disturbance range at baseline to the no sleep disturbance range by week 4 and remained there through week 12, according to the company.¹

Actigraphy from a medical-grade wearable showed improvements in wakefulness after sleep onset, sleep efficiency, sleep latency, and nighttime awakenings at all 3 follow-up visits (P < .05), Astellas reported. The mean reduction in nighttime awakenings reached 2.6 by week 12. The release did not provide baseline awakening frequency, absolute changes in the other sleep measures, or the number of participants included in this analysis.¹

“Hot flashes and night sweats can have a far-reaching impact on women’s daily lives, including their sleep, quality of life and overall well-being,” lead author Marla Shapiro, CM, of the University of Toronto, said in a press release.² “These preliminary real-world findings add to the growing body of evidence from OPTION-VMS, demonstrating improvements in bothersome vasomotor symptoms and sleep outcomes among women treated with fezolinetant. Taken together with the broader study findings, these data contribute to a more complete understanding of women's experiences in routine clinical practice and may help inform discussions between women and their healthcare providers."

Two Mild Liver Test Elevations Reported; Monitoring Still Required

Astellas reported 2 cases of mildly elevated liver tests that were nonserious and did not lead to treatment or study discontinuation. No new safety signals were identified in this preliminary analysis.¹ Fezolinetant carries an FDA boxed warning for hepatotoxicity. Its prescribing information calls for hepatic laboratory testing before treatment, monthly during the first 3 months, and again at months 6 and 9.³

Fezolinetant is a neurokinin 3 receptor antagonist approved in the US for moderate to severe VMS due to menopause. These findings add objective sleep measurements to the reported experience of women receiving the drug in practice. Because OPTION-VMS is observational and this analysis compared outcomes with each patient’s baseline, the results cannot establish that fezolinetant caused the sleep changes or that it improves sleep more than another nonhormonal treatment.¹

References

1. Shapiro M, et al. Fezolinetant and real-world sleep outcomes in the phase 4 OPTION-VMS study: second preliminary analysis of patient-reported and actigraphy-derived endpoints. Abstract 2693-MA-3457. Presented at: IMS 20th World Congress on Menopause; 2026.
2. Astellas Pharma. New preliminary real-world Veozah (fezolinetant) data highlights improvements in menopause-related symptoms and sleep outcomes. News release. Published October 2, 2026. Accessed October 2, 2026. https://www.prnewswire.com/news-releases/new-preliminary-real-world-veozah-fezolinetant-data-highlights-improvements-in-menopause-related-symptoms-and-sleep-outcomes-302896843.html
3. US Food and Drug Administration. Veozah (fezolinetant) prescribing information. Revised December 2024. Accessed October 2, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s004lbl.pdf