Longevity
Non-hormonal menopause drugs ease sleep problems in meta-analysis of 3,184 women
By John Hyland, . Life and Health Today.
Sleep improved meaningfully within a month of starting a non-hormonal menopause drug, according to a meta-analysis of seven placebo-controlled randomized trials covering 3,184 women, presented at the Menopause Society annual meeting and published simultaneously in the journal Menopause.
The drugs studied belong to a class called neurokinin-receptor antagonists, which work by targeting the brain's thermoregulation center, the system that governs body temperature and is disrupted during menopause, producing hot flashes and the broken sleep that often follows. Two drugs in this class are currently FDA-approved for vasomotor symptoms, the medical term for hot flashes and night sweats: fezolinetant, sold as Veozah, and elinzanetant, sold as Lynkuet.
What the analysis measured
Maria Julia Lemos, a physician at Kurah Women's Health Institute in Maceá, Brazil, led the research team. They searched three major medical databases through May 2026 and identified seven eligible trials: OASIS I, II, and III; SWITCH-1; DAYLIGHT; and SKYLIGHT I and II pooled, along with a 2019 trial by Depypere. All seven were rated low risk of bias.
Five of the seven trials used the same validated sleep questionnaire, the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b, which asks participants about sleep quality, restfulness, and difficulty falling and staying asleep over the previous seven days. Those five were pooled for the primary analysis; the other two used different instruments and were analyzed separately.
Compared with placebo, the drugs were associated with reduced sleep disturbance at four weeks, twelve weeks, and twenty-four weeks. The effect was largest early and narrowed over time, though it remained statistically significant at all three points.
How the two drugs compared
Subgroup analyses showed that both drugs improved sleep through twelve weeks, but elinzanetant showed a larger effect at both the four-week and twelve-week marks. The difference between the two was statistically significant at both time points, according to the report in Menopause. Lemos told MedPage Today that head-to-head trials directly comparing the two drugs are still needed before any firm conclusions can be drawn about which performs better.
Across the pooled trials, 949 women took fezolinetant, 864 took elinzanetant, and 1,371 received placebo, for a combined total of 3,184 participants. The participants had a mean age of 54.5 years.
Why this analysis was done
Lemos told MedPage Today that large trials of these drugs had measured sleep as a secondary outcome rather than a primary one, and no prior meta-analysis had focused on sleep specifically. "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," she said. "They may help women sleep better, not just have fewer hot flashes."
Hormone therapy remains the preferred treatment for vasomotor symptoms, but some women cannot use it because of contraindications such as a history of certain cancers or blood clots, and others prefer to avoid it.
JoAnn Manson, a physician and professor at Harvard Medical School who is a past president of the Menopause Society and was not involved in the research, told MedPage Today that the analysis "fills an important knowledge gap, as information on efficacy of treatments for vasomotor symptoms in reducing sleep disturbance has been limited."
What the analysis cannot settle
Lemos identified several limits in the report. The number of included trials was relatively small. Sleep outcomes were self-reported rather than measured by devices or clinical observation. The trials varied in patient characteristics, dosing regimens, and follow-up length, producing high statistical heterogeneity. And because hot flashes and sleep disruption are closely linked, the analysis cannot separate a direct effect on sleep from the broader benefit of reducing vasomotor symptoms.
What the analysis does establish is that in women with moderate-to-severe hot flashes who took one of these two approved drugs in a controlled trial setting, sleep disturbance scores improved compared with placebo, and that improvement appeared within four weeks. Whether one drug is meaningfully better than the other for sleep, and how these results translate to women outside trial conditions, remains an open question that only direct comparison trials can answer.
Anyone weighing these options should discuss their own medical history with a clinician, since both drugs carry specific prescribing considerations.
Source: https://www.medpagetoday.com/meetingcoverage/tms/123533
Life & Health Today provides information for educational purposes only, not medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional.