Elinzanetant Provides VMS-Independent Sleep Improvement in Postmenopausal Women: Daily Dose

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On October 22, 2025, we reported on a study presented at The Menopause Society 2025 Annual Meeting that was designed to quantify how much of elinzanetant's sleep benefit operates independently of nighttime vasomotor symptom (VMS) reduction vs through VMS reduction.

The study

Investigators pooled 12-week data from the elinzanetant 120 mg and placebo arms of 3 phase 3 trials (OASIS-1, -2, -3) and a single phase 2 trial (NIRVANA). The OASIS cohorts enrolled postmenopausal women with moderate-to-severe VMS (50 or more per week for OASIS-1 and -2, with no minimum requirement for OASIS-3) but there were no requirements imposed for sleep disturbances. NIRVANA enrolled postmenopausal women with VMS (20 or more per week) and sleep disturbances.

A total of 1345 participants documented VMS frequency twice daily via morning diary (recalling nighttime VMS) and evening diary (recalling daytime VMS). Researchers assessed sleep disturbances using PROMIS SD SF 8b T-scores at weeks 1, 2, 3, 4, 8, and 12.

The findings

The total effect of elinzanetant versus placebo was −4.92 points (95% CI −5.73 to −4.12). The natural direct effect accounted for −2.67 points (95% CI −3.28 to −2.07), while the natural indirect effect contributed −2.25 points (95% CI −2.81 to −1.69). The researchers calculated that the proportion of total effect attributable to direct effects of elinzanetant on sleep was 54.3% (95% CI 45.8 to 62.8).

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