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A meta-analysis of seven placebo-controlled trials found that neurokinin-receptor antagonists were associated with improved sleep-disturbance scores in women with moderate-to-severe menopausal hot flashes. Improvements were reported from four weeks through 24 weeks, but the analysis does not show whether sleep improved independently of hot-flash relief, and it did not directly compare the drugs.
A meta-analysis of seven placebo-controlled trials found that neurokinin-receptor antagonists were associated with reduced sleep disturbance among women with moderate-to-severe menopausal hot flashes, with improvement reported as early as four weeks. The findings, presented by researchers at the Menopause Society annual meeting, add evidence about sleep outcomes for women considering nonhormonal treatment for vasomotor symptoms.
The analysis included 3,184 women: 949 who received fezolinetant, 864 who received elinzanetant and 1,371 who received placebo. Across the pooled results, sleep-disturbance scores favored the medicines at four, 12 and 24 weeks. The reported standardized mean differences were -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).
Those pooled estimates came from five trials that used the same Patient-Reported Outcomes Measurement Information System sleep questionnaire. The other two trials used different questionnaires and were analyzed separately. On the PROMIS measure, lower scores indicate less sleep disturbance; participants reported on sleep quality, restfulness, and difficulty falling or staying asleep over the previous seven days.
In subgroup analyses, both drugs were associated with significant sleep improvements through 12 weeks. The researchers reported a larger effect for elinzanetant than fezolinetant at four weeks and 12 weeks. These are comparisons across trial data, however, and not the result of a head-to-head trial directly assigning patients to one drug or the other.
Sleep Outcomes Beyond Hot Flashes
Sleep disruption can be a major concern for people experiencing menopause-related hot flashes, but trials of treatments for vasomotor symptoms have often treated sleep as a secondary outcome. The analysis brings together results from multiple trials to assess that outcome, offering more information for patients and clinicians weighing nonhormonal options.
The findings may be particularly relevant to women who cannot take menopausal hormone therapy or prefer not to use it. The authors and outside expert quoted by MedPage Today said the results support considering these drugs when sleep problems accompany hot flashes. The study does not establish that the medicines treat sleep disorders generally, nor does it show that sleep improvement is separate from relief of hot flashes.
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How the Trial Evidence Was Combined
Researchers led by Maria Julia Lemos, MD, of Kurah Women’s Health Institute in Macaé, Brazil, searched PubMed, Embase and Cochrane for studies published through May 2026. Their review included seven placebo-controlled trials: OASIS I, II and III; SWITCH-1; DAYLIGHT; pooled SKYLIGHT I and II results; and Depypere 2019. The trials were rated as having a low risk of bias by the review team.
Both medicines belong to a class of drugs that acts on neurokinin receptors involved in thermoregulation, the process by which the brain regulates body temperature. Fezolinetant is an NK3 receptor antagonist; elinzanetant targets NK1 and NK3 receptors. In the report, both were described as recommended nonhormonal treatments for vasomotor symptoms. Menopausal hormone therapy remains a preferred treatment for vasomotor symptoms for many patients, but it is not suitable or desired for everyone.
“They may help women sleep better, not just have fewer hot flashes.”
— Maria Julia Lemos, MD, lead researcher, speaking to MedPage Today
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Limits of the Sleep Findings
The review included only seven trials, and the studies varied in patient groups, treatment regimens and follow-up periods. Sleep outcomes were based on patient reports rather than a single objective measure. Although five trials used the same questionnaire and could be pooled, two used different measures and were considered separately.
The results also cannot establish whether the sleep changes occurred directly or followed improvements in hot flashes. The reported difference between elinzanetant and fezolinetant came from subgroup analyses, not a randomized comparison of the two drugs within the same trial. Direct comparative evidence is still needed, and the report does not establish how these results apply to people without moderate-to-severe vasomotor symptoms.
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Evidence Needed From Direct Comparisons
Lemos said that head-to-head trials comparing fezolinetant with elinzanetant are still needed. Such studies could test differences between the drugs more directly and help clarify whether one has a greater effect on sleep under comparable conditions.
For now, the meta-analysis offers a pooled view of sleep-related outcomes from existing trials, rather than a new trial or a change to treatment guidance. Clinicians and patients will need to weigh the findings alongside individual symptoms, treatment preferences and medical circumstances; the review itself does not determine which option is appropriate for a particular person.
Key Questions
What did the meta-analysis find?
It found that neurokinin-receptor antagonists were associated with improved sleep-disturbance scores in trial participants with moderate-to-severe menopausal hot flashes. Improvements were reported at four, 12 and 24 weeks in pooled results.
Which drugs were included?
The analysis covered fezolinetant and elinzanetant, along with placebo groups. Fezolinetant targets NK3 receptors, while elinzanetant targets NK1 and NK3 receptors.
Does the study prove these medicines improve sleep independently of hot-flash relief?
No. The researchers said it was not possible to separate sleep benefits from relief of vasomotor symptoms in the included evidence.
Was one drug shown to work better than the other?
Subgroup analyses found a larger reported effect for elinzanetant at four and 12 weeks. But the drugs were not compared directly in a head-to-head trial, so the result does not establish which is more effective.
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