Elinzanetant Linked to Broad Improvements in Sleep Disturbance in Women With Moderate-to-Severe Vasomotor Symptoms

Women with moderate to severe vasomotor symptoms (VMS) who received elinzanetant (Lynkuet; Bayer) were more likely than those receiving placebo to report improvement on every item of a validated sleep disturbance questionnaire after 12 weeks. The findings come from a post hoc analysis of the phase 3 OASIS 1 and 2 trials set to be presented at the 2026 Annual Meeting of The Menopause Society.¹

Elinzanetant is a dual neurokinin-1 and neurokinin-3 receptor antagonist. The proportion of women reporting poor or very poor sleep quality fell from 65.6% at baseline to 20.5% at week 12 with elinzanetant, compared with a decline from 57.8% to 38.7% with placebo.¹

Background on the OASIS trials

OASIS 1 and 2 were randomized, double-blind phase 3 trials conducted at 77 sites each across the US, Canada, Europe, and Israel. Women aged 40 to 65 years with natural or surgical menopause and at least 50 moderate to severe VMS per week were enrolled. In total, 399 participants were randomized to elinzanetant and 397 to placebo.^1,2

Each trial lasted 26 weeks, with the first 12 weeks placebo controlled. In the primary analyses, elinzanetant significantly reduced VMS frequency and severity compared with placebo at weeks 4 and 12 in both trials.^1,2

Analysis of individual sleep items¹

In this exploratory analysis, James A. Simon, MD, of George Washington University, and colleagues pooled data from both trials. They examined responses to the 8 items of the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b).

The instrument uses a 7-day recall period and a 5-point Likert scale to assess restless sleep, sleep satisfaction, refreshing sleep, difficulty falling asleep, staying asleep, and getting to sleep, amount of sleep, and sleep quality. The researchers used descriptive statistics to compare the proportion of women in each response category by treatment arm over time.

Key findings¹

Baseline responses were largely comparable between groups. The most frequently reported sleep problems for the elinzanetant vs placebo groups were:

• Sleep dissatisfaction (78.2% vs 69.6%)
• Difficulty staying asleep (77.2% vs 72.0%)
• Nonrefreshing sleep (73.4% vs 68.3%)

By week 12, a higher proportion of women in the elinzanetant group than in the placebo group reported improved scores on all 8 items.

Sleep quality showed one of the clearest differences between groups. Among women receiving elinzanetant, the proportion reporting poor or very poor sleep quality fell from 65.6% at baseline to 20.5% at week 12, a decline of about 45 percentage points. In the placebo group, the proportion fell from 57.8% to 38.7%, a decline of about 19 percentage points.

The investigators concluded that the results indicate overall improved sleep quality with elinzanetant in women with moderate to severe VMS due to natural or surgical menopause.

Limitations

The analysis was post hoc and exploratory and relied on descriptive statistics, without formal between-group significance testing for individual items. Participants were enrolled based on VMS burden rather than a primary sleep complaint, so the results may not apply to women whose sleep problems are unrelated to VMS.¹

References

1. Simon JA, Pinkerton JV, Seitz C, Caetano C, Gkioni I, Panay N. Improvements in sleep disturbance with elinzanetant: analysis of PROMIS SD SF 8b domains from the OASIS-1 and -2 clinical trials. Abstract P-120. Presented at: 2026 Annual Meeting of The Menopause Society; October 20-24, 2026; San Diego, CA.
2. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618