TL;DR
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A meta-analysis of seven placebo-controlled trials found that two non-hormonal menopause drugs were associated with improved patient-reported sleep disturbance among women with moderate-to-severe vasomotor symptoms. Benefits were observed by four weeks and continued at later measured points, but the analysis cannot determine how much improvement came from better sleep directly versus fewer hot flashes.
A meta-analysis of seven randomized trials found that non-hormonal neurokinin-receptor antagonists were associated with less reported sleep disturbance in menopausal women with moderate-to-severe hot flashes, with a benefit detectable at four weeks. The findings, presented by Maria Julia Lemos at the Menopause Society annual meeting and published in Menopause, add evidence about sleep outcomes for women seeking alternatives to hormone therapy.
The analysis pooled data from 3,184 women enrolled in placebo-controlled trials of fezolinetant or elinzanetant. Compared with placebo, treatment was associated with improvement on the PROMIS Sleep Disturbance-Short Form 8b at four weeks, 12 weeks and 24 weeks. On that questionnaire, a lower score indicates less sleep disturbance; it asks about sleep quality, restfulness, and difficulty falling or staying asleep over the previous seven days.
Across the pooled results, the reported standardized mean difference was -3.94 at four weeks (95% confidence interval -5.71 to -2.16), -3.11 at 12 weeks (-4.60 to -1.61), and -2.04 at 24 weeks (-3.93 to -0.15), compared with placebo. The researchers also reported significant sleep improvements through 12 weeks in separate analyses of both medicines. The reported effect was larger for elinzanetant than fezolinetant at four and 12 weeks, but the findings do not come from a direct head-to-head trial.
Five included trials used the same PROMIS questionnaire and were pooled for the primary sleep analysis. Two other trials used different questionnaires and were assessed separately. The seven studies included the OASIS, SWITCH-1, DAYLIGHT and SKYLIGHT trials, as well as a 2019 study. The researchers reported that all included trials had a low risk of bias, while also noting differences among participants, treatment regimens and follow-up periods.
Sleep Benefits for Non-Hormonal Care
Sleep disruption can be a major concern for people experiencing menopause-related hot flashes and night sweats. The findings suggest that NK-receptor antagonists may ease sleep disturbance alongside their effect on vasomotor symptoms, giving clinicians and patients more evidence to discuss when considering non-hormonal treatment.
The results may be particularly relevant to women who cannot use menopausal hormone therapy or prefer not to. They do not establish that either drug should replace hormone therapy for everyone, nor do they show that the sleep effect is separate from reduced hot flashes. The analysis measured reported sleep symptoms, not an independent objective measure of sleep, and it does not compare the medicines directly.
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How the Drug Evidence Was Assembled
Menopausal hormone therapy is a preferred treatment for vasomotor symptoms, but it is not suitable or preferred for every patient. Fezolinetant blocks the NK3 receptor, while elinzanetant acts on both NK1 and NK3 receptors. These medicines target brain pathways involved in thermoregulation and are used as non-hormonal treatments for vasomotor symptoms.
Lemos and colleagues said that although major trials had measured sleep as a secondary outcome, there had not been a meta-analysis focused on sleep disturbance. Their team searched PubMed, Embase and Cochrane from their inception through May 2026. Of the 3,184 participants, 949 received fezolinetant, 864 received elinzanetant and 1,371 received placebo. The mean age was 54.5 years and the mean body mass index was 27.7.
“For women with hot flashes who can’t or don’t want to use hormone therapy, especially when poor sleep is one of their main complaints, these drugs are a good option to consider.”
— Maria Julia Lemos, MD, lead researcher, speaking to MedPage Today
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Limits of the Sleep Findings
The results do not establish how much of the improvement in sleep was a direct drug effect and how much followed from fewer or less disruptive hot flashes. The sleep outcome was patient-reported, and the researchers noted a relatively small number of trials and substantial variation in participants, treatment schedules and follow-up.
The reported differences between elinzanetant and fezolinetant come from subgroup analyses across trials, not a randomized comparison of the two drugs in the same study. The analysis also does not show that every patient will experience better sleep or establish how the measured score changes translate into everyday functioning. Longer-term effects beyond the reported follow-up and results in groups unlike those studied remain uncertain.
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Direct Drug Comparisons Still Needed
The next evidence milestone identified by Lemos is a head-to-head trial comparing fezolinetant with elinzanetant. Such a study could test whether the difference in sleep-score effects seen in the subgroup analyses persists under a direct comparison. The report does not specify when such a trial will begin or when results could be available.
For now, the findings add sleep data to the evidence on these medicines for vasomotor symptoms, but treatment decisions remain a matter for patients and clinicians. Further research can clarify whether sleep improvement is independent of hot-flash relief, how durable it is, and which patients are most likely to benefit.
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Key Questions
Which drugs were included in the analysis?
The analysis examined fezolinetant, an NK3 receptor antagonist, and elinzanetant, a dual NK1/NK3 receptor antagonist, alongside placebo groups in the included trials.
How soon did the analysis find a sleep benefit?
The pooled analysis reported improvement in patient-reported sleep-disturbance scores by four weeks, with benefits also reported at 12 and 24 weeks compared with placebo.
Does the study prove the drugs directly improve sleep?
No. The analysis found better reported sleep scores, but it could not separate a direct effect on sleep from improvement linked to fewer or less disruptive vasomotor symptoms, such as hot flashes.
Was one medicine shown to be better than the other?
Subgroup analyses showed a larger reported effect for elinzanetant than fezolinetant at four and 12 weeks. However, researchers said head-to-head trials are still needed; the meta-analysis was not a direct randomized comparison of the two drugs.
Source: rss
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