Actigraphy and Objective Sleep Outcomes in Menopause VMS Treatment

This content is sponsored by Astellas, Inc but was independently developed by MJH Life Sciences

Pauline M. Maki, PhD, explains the difference between measuring sleep objectively with actigraphy and asking women to rate their sleep on a questionnaire. Both are important, she says: Clinicians treat women's own perception of their sleep in day-to-day practice, but objective measures add scientific precision. Polysomnography is the gold standard but is not feasible in a real-world study such as OPTION-VMS, so actigraphy, measured with a watch-like device that tracks movement, offers a practical objective readout.

Studies comparing actigraphy with self-report generally find that the devices detect more sleep problems than women report, Maki notes, particularly wakefulness after sleep onset (WASO), the key sleep feature that worsens across the transition from premenopause to perimenopause to postmenopause. Self-report can differ because women must recall their sleep and must have been aroused from sleep long enough to perceive that they woke up.

Maki then reviews the actigraphy findings. Fezolinetant (Veozah) was associated with significant improvements in WASO at 12 weeks, the primary outcome, with sleep effects emerging even earlier. OPTION-VMS captured whatever providers prescribed, including fezolinetant, SSRIs or SNRIs used off label, and other agents such as oxybutynin or gabapentin. In this first data cut, the SSRI/SNRI group did not show a significant change in WASO from baseline to 12 weeks, which she says suggests this bothersome symptom may not improve as much, when measured objectively, in women who take these agents.1

Maki cautions that OPTION-VMS did not directly compare the treatment groups, so it did not test the magnitude of WASO improvement with fezolinetant vs SSRIs/SNRIs. Together with the subjective improvement in sleep, she describes the findings as reassuring that fezolinetant is likely working for sleep.

In the next segment, Maki walks through the real-world safety experience with fezolinetant and the hepatic monitoring and dosing details prescribers need to know.