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A meta-analysis of seven placebo-controlled trials found that neurokinin-receptor antagonists were associated with improved patient-reported sleep disturbance among women with moderate-to-severe menopausal hot flashes. Benefits were reported from four weeks, but the analysis cannot show whether sleep improved separately from hot flashes, and it did not compare the drugs directly in head-to-head trials.
A meta-analysis of seven placebo-controlled trials found that two non-hormonal neurokinin-receptor antagonists were associated with less patient-reported sleep disturbance among menopausal women with moderate-to-severe vasomotor symptoms, with improvement reported as early as four weeks. The findings, presented at the Menopause Society annual meeting and reported by MedPage Today, may help inform treatment discussions for women who cannot or do not want to use hormone therapy.
The review, led by Maria Julia Lemos, MD, of Kurah Women’s Health Institute in Brazil, combined results from seven placebo-controlled trials of fezolinetant and elinzanetant. The trials included 3,184 women: 949 received fezolinetant, 864 received elinzanetant and 1,371 received placebo. Their mean age was 54.5 years. The researchers reported that all included trials had a low risk of bias.
In studies using the same validated sleep questionnaire, the combined analysis found improvement relative to placebo at four weeks, 12 weeks and 24 weeks. Five trials used the PROMIS Sleep Disturbance Short Form 8b, which asks about sleep quality, restfulness, and difficulty falling or staying asleep during the previous seven days. On that scale, lower scores indicate less reported sleep disturbance. Two other trials used different questionnaires and were analyzed separately.
In subgroup analyses, both drugs significantly improved sleep through 12 weeks. The analysis reported a larger effect for elinzanetant than fezolinetant at four and 12 weeks. Those estimates are comparisons across trial subgroups, not results from a direct head-to-head trial, and should not be read as proof that one drug is superior for individual patients.
Sleep as a Treatment Outcome
Hot flashes and other vasomotor symptoms can disrupt sleep, and poor sleep is a major concern for some women seeking menopause treatment. The findings add evidence about a possible non-hormonal treatment option for patients whose symptoms warrant treatment but who cannot use, or prefer not to use, hormone therapy. The reported early change may also be relevant to conversations about how soon a patient might notice a difference.
The result does not establish that these medicines treat insomnia as a separate condition. The researchers said the analysis could not distinguish sleep improvement caused directly by the drugs from improvement resulting from fewer or less severe hot flashes. Treatment decisions still depend on a patient’s health history, symptoms, and discussion with a clinician; this analysis does not establish which drug is best for a particular person.
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How the Trial Evidence Was Combined
Menopausal hormone therapy is a preferred treatment for vasomotor symptoms for many patients, but it is not appropriate for everyone, and some women seek alternatives. Fezolinetant, sold as Veozah, blocks the NK3 receptor; elinzanetant, sold as Lynkuet, acts on both NK1 and NK3 receptors. These medicines target brain pathways involved in temperature regulation and are used for vasomotor symptoms, including hot flashes.
Lemos and colleagues searched PubMed, Embase and Cochrane for studies available through May 2026. Their review followed earlier large trials in which sleep was measured as a secondary outcome. Lemos told MedPage Today that the lack of a previous meta-analysis focused on sleep was the reason for undertaking this review. The new analysis brings those trial results together but relies on participants’ own reports of sleep rather than a single objective measure.
“They may help women sleep better, not just have fewer hot flashes.”
— Maria Julia Lemos, MD, speaking to MedPage Today
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Limits of the Sleep Findings
The analysis included only seven trials, with differences in participants, treatment regimens and follow-up periods. Lemos said the review had high heterogeneity, and sleep outcomes were based on patient-reported measures. Although the authors reported improvements through 24 weeks in the pooled results, the subgroup finding for each drug was described through 12 weeks.
The analysis also cannot determine how much of the sleep change was independent of relief from hot flashes. The reported larger effect for elinzanetant came from comparisons of separate trial subgroups, not a randomized direct comparison between the medicines. The findings do not establish comparative effectiveness, long-term sleep outcomes, or which patients are most likely to benefit.
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Direct Comparisons Still Needed
The immediate next step identified by Lemos is head-to-head research comparing fezolinetant and elinzanetant. Such trials could help clarify their relative effects on sleep and vasomotor symptoms under the same study conditions. Further research may also help separate changes in sleep from changes in hot flashes.
For now, the findings provide additional evidence from existing trials rather than a new treatment recommendation. Patients considering a non-hormonal medicine for menopause symptoms should discuss options and personal health factors with a qualified clinician.
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Key Questions
Which medicines were included in the analysis?
The analysis included trials of fezolinetant and elinzanetant, non-hormonal neurokinin-receptor antagonists used for menopausal vasomotor symptoms.
How soon did the analysis find a sleep benefit?
The pooled results showed improved sleep-disturbance scores relative to placebo as early as four weeks. This refers to group-level trial findings, not a guarantee of when an individual will notice a change.
Does the study show that one drug works better?
No direct head-to-head trial was included. The analysis reported a larger effect for elinzanetant in subgroup comparisons, but those comparisons do not establish that it is superior to fezolinetant.
Can the drugs be considered treatments for insomnia?
The review examined sleep disturbance in women being treated for vasomotor symptoms. It could not separate sleep changes from relief of hot flashes, so it does not establish these medicines as stand-alone insomnia treatments.
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