TL;DR
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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 in menopausal women with moderate-to-severe vasomotor symptoms. Benefits appeared by four weeks and continued through 24 weeks, but the analysis cannot show whether sleep improved independently of hot-flash relief.
A meta-analysis of seven placebo-controlled trials found that neurokinin-receptor antagonists were associated with improved patient-reported sleep disturbance among menopausal women with moderate-to-severe vasomotor symptoms, with benefits measured as early as four weeks. The findings, presented by Maria Julia Lemos at the Menopause Society annual meeting and published in Menopause, add evidence on sleep outcomes for women considering nonhormonal treatment for hot flashes.
The analysis covered 3,184 women in trials of fezolinetant, elinzanetant or placebo. Five trials used the same validated sleep questionnaire, the PROMIS Sleep Disturbance-Short Form 8b, and were pooled for the main analysis; two trials used different questionnaires and were assessed separately. Lower scores on the PROMIS measure indicate less sleep disturbance.
Compared with placebo, the pooled results showed improvement at four weeks (standardized mean difference, or SMD, −3.94; 95% confidence interval −5.71 to −2.16), at 12 weeks (SMD −3.11; 95% CI −4.60 to −1.61), and at 24 weeks (SMD −2.04; 95% CI −3.93 to −0.15). The researchers reported that both drugs significantly improved sleep through 12 weeks in subgroup analyses.
The subgroup results showed a larger measured effect for elinzanetant than fezolinetant at four and 12 weeks. At four weeks, the SMDs were −5.24 and −1.98, respectively; at 12 weeks, they were −4.52 and −1.44. These are comparisons across trial data, not evidence from a direct head-to-head trial. The authors said direct comparisons are still needed.
Sleep Outcomes for Nonhormonal Care
Sleep disruption can be a major complaint for people experiencing menopausal hot flashes and night sweats. The findings give clinicians and patients more information about a potential benefit of nonhormonal treatments, particularly for those who cannot use, or prefer not to use, menopausal hormone therapy. The results do not establish that these medicines should be chosen specifically as sleep treatments, but they suggest sleep improvement may accompany treatment of vasomotor symptoms.
Maria Julia Lemos told MedPage Today that the drugs “may help women sleep better, not just have fewer hot flashes.” JoAnn E. Manson of Harvard Medical School, who was not involved in the research, called the analysis a contribution to an area where treatment evidence on sleep has been limited. She described the results as meaningful because improvement was reported early and continued over the study periods. These are expert assessments of the findings, not separate clinical trial results.
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Trials Behind the Sleep Analysis
Neurokinin-receptor antagonists act on pathways involved in the brain’s regulation of body temperature. The drugs can reduce vasomotor symptoms such as hot flashes; disrupted sleep may improve alongside those symptoms. Fezolinetant is an NK3-receptor antagonist, while elinzanetant acts on NK1 and NK3 receptors. Both are nonhormonal treatments recommended for vasomotor symptoms.
Lemos and colleagues searched PubMed, Embase and Cochrane through May 2026. They included seven placebo-controlled trials, with 949 participants taking fezolinetant, 864 taking elinzanetant and 1,371 receiving placebo. The mean participant age was 54.5 years. The researchers undertook the review because large drug trials had measured sleep as a secondary outcome, but a meta-analysis focused on sleep had not been conducted, according to the report.
“They may help women sleep better, not just have fewer hot flashes.”
— Maria Julia Lemos, MD, of Kurah Women’s Health Institute, speaking to MedPage Today
Limits of the Sleep Evidence
The findings rely in part on patient-reported sleep scores, and the analysis included relatively few trials. Lemos also cited differences among participants, treatment regimens and follow-up periods. Because sleep was assessed alongside treatment for vasomotor symptoms, the analysis cannot determine whether improved sleep resulted directly from a drug effect on sleep or from fewer hot flashes and related symptoms.
The apparent difference between the two drugs should also be interpreted cautiously: the subgroup comparisons do not replace a randomized head-to-head trial. The results do not establish which medicine is more effective for a particular patient, whether the measured improvements apply equally across groups, or how benefits compare with other approaches to sleep problems.
Direct Drug Comparisons Needed
The next evidence milestone identified by Lemos is a head-to-head trial comparing fezolinetant with elinzanetant. Such a study could more directly assess differences in sleep outcomes and reduce the uncertainty that comes from comparing results across separate trials. The meta-analysis does not specify when such research may be completed.
For now, the reported results add sleep data to evidence on nonhormonal treatment of menopausal vasomotor symptoms. The analysis does not change the need to weigh treatment options with a qualified health professional, particularly because it cannot show whether the sleep benefit is independent of hot-flash relief.
Key Questions
Which drugs were included in the meta-analysis?
The analysis included trials of fezolinetant, an NK3-receptor antagonist, and elinzanetant, a dual NK1/NK3-receptor antagonist, compared with placebo.
How soon did the analysis find a sleep benefit?
The pooled results showed improved sleep-disturbance scores by four weeks, with improvements also reported at 12 and 24 weeks. The evidence reflects trial measurements at those time points.
Does the analysis prove the drugs directly improve sleep?
No. The researchers said they could not separate sleep improvement from relief of hot flashes and other vasomotor symptoms. The sleep outcomes were also based on participants’ reports.
Was one drug shown to work better than the other?
Subgroup analyses showed larger measured effects for elinzanetant at four and 12 weeks, but the drugs were not compared in a direct head-to-head trial. The authors said such trials are still needed.
Who might find the findings relevant?
The results may be relevant to menopausal women with moderate-to-severe vasomotor symptoms who are considering nonhormonal options, including people who cannot or do not want to use hormone therapy. Treatment decisions should be discussed with a qualified health professional.
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