IMS: Fezolinetant's improvements in sleep quality, hot flashes as early as week 4

Treatment with fezolinetant (Veoza; Astellas) was associated with statistically significant improvements in bothersome vasomotor symptoms (VMS) and in both patient-reported and objectively measured sleep outcomes as early as week 4, according to a preliminary analysis of the phase 4 OPTION-VMS real-world study presented at the 2026 International Menopause Society (IMS) 20th World Congress on Menopause.

"Hot flushes and night sweats can have a far-reaching impact on women's daily lives, including their sleep, quality of life and overall well-being,” said Marla Shapiro, C.M., of the Department of Family and Community Medicine at the University of Toronto, Canada, and lead author of the OPTION-VMS oral presentation.

“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,” Shapiro said.

According to an announcement from Astellas, improvements were maintained through weeks 8 and 12, including a mean reduction of 2.6 nighttime awakenings from baseline at week 12.

Fezolinetant is a nonhormonal, selective neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B binding on kisspeptin/neurokinin/dynorphin (KNDy) neurons, which can help regulate the temperature control center in the hypothalamus.

Sleep disturbances are among the most commonly reported and bothersome menopause symptoms, affecting an estimated 40% to 60% of menopausal women, according to Astellas. Women with moderate to severe hot flushes are almost 3 times more likely to report frequent nighttime awakenings than women without hot flushes.

How was the OPTION-VMS real-world study designed?

OPTION-VMS (NCT06049797) is an ongoing phase 4, longitudinal, observational study of women aged 40 to 75 years with confirmed menopausal VMS who were prescribed a nonhormonal therapy by their health care provider in routine clinical practice. Therapies included fezolinetant 45 mg, SSRIs or SNRIs, and other non-hormonal options such as gabapentin and oxybutynin.

The primary endpoint was change from baseline in bothersome VMS after 12 weeks, measured by the MENQOL VMS domain score. Additional outcomes include sleep quality, menopause-related quality of life, sexual health, mood, work productivity, and safety.

The study pairs patient-reported sleep measures with objective actigraphy data collected through a medical-grade wearable device, but was not designed to assess differences between treatment groups.

Fezolinetant effects on VMS and sleep through week 12

Among women treated with fezolinetant, MENQOL VMS domain scores improved significantly from baseline at weeks 4, 8, and 12 (P < 0.001 for all), with reductions exceeding the threshold for minimal clinically important difference.

Patient-reported sleep disturbance, assessed with the PROMIS SD SF 8b, also improved significantly at each time point (P < 0.001). Scores moved from the mild sleep disturbance range at baseline to the no sleep disturbance range by week 4, with improvements maintained through week 12, according to Astellas.

Objective measures followed a similar pattern, as wakefulness after sleep onset, sleep efficiency, sleep latency, and nighttime awakenings each improved significantly from baseline at weeks 4, 8, and 12 (P < 0.05).

No new safety signals were observed. Hepatic laboratory findings were mild and infrequent, with 2 nonserious cases of mildly elevated tests, none of which led to treatment or study discontinuation.

“We could see that there were improvements in all of this at week 4, which was the first time point assessed, and it reassures me when I see objective findings that are consistent with improvements in the patient-reported outcome,” Shapiro told Contemporary OB/GYN in a recent interview. “So when the subjective patient-reported and the objective actigraph improvements in sleep are noted at the same time points, week 4 and sustained, they are concordant. They show us that we have objective measurements that there are improvements in sleep disturbances and improved sleep quality,” she said.

Reference:

New preliminary real-world VEOZA (fezolinetant) data highlights improvements in menopause-related symptoms and sleep outcomes. Astellas. Email News release. Published October 1, 2026. Accessed October 1, 2026.