Multi-modality impact of elinzanetant's effect on postmenopausal sleep disturbance

Elinzanetant demonstrated consistent reductions in wakefulness after sleep onset (WASO) compared with placebo across differing sleep assessment modalities in postmenopausal women with vasomotor symptoms (VMS), according to a post hoc analysis of the phase 2 NIRVANA trial presented as a poster at SLEEP 2026 in Baltimore, Maryland.

Nighttime wakefulness is a common and burdensome complaint among postmenopausal women with VMS, yet most prior evidence for elinzanetant's effect on sleep has relied on patient-reported outcomes. The NIRVANA trial was the first to evaluate the drug's impact on WASO using both objective and subjective measurement tools simultaneously, providing a more comprehensive picture of its effects on sleep architecture in this population.

What was the NIRVANA trial design?

The phase 2 NIRVANA trial randomized 110 postmenopausal women with polysomnography (PSG)-confirmed WASO of 30 minutes or more and 20 or more moderate-to-severe VMS per week to elinzanetant 120 mg (n = 55) or placebo (n = 55) once daily for 12 weeks. Sleep disturbances were assessed using 3 modalities:

• In-lab PSG for all participants, conducted at baseline, week 4, and week 12 over 2 consecutive nights per timepoint
• The contactless home-monitoring device Sleepiz One+ in a subset of participants (elinzanetant: n = 33, placebo: n = 33), collected nightly
• Patient-reported Sleep Diary data collected nightly for all participants

WASO values were analyzed on the original scale for consistency across measures, and a post hoc random coefficient model was used to estimate overall treatment effects over 12 weeks for each modality.

For a further breakdown of these findings, watch our interview with study author Fiona Baker, PhD.

WASO reductions across all 3 modalities

Elinzanetant demonstrated numerical reductions in WASO versus placebo across all 3 assessment modalities. PSG findings showed a baseline mean WASO of 74.7 (SD 34.8) minutes for elinzanetant versus 82.8 (SD 34.4) minutes for placebo, with an overall treatment effect favoring elinzanetant (least squares [LS] mean difference: -10.1 minutes; unadjusted 95% CI: -18.5, -1.6).

Results from the Sleepiz One+ home monitoring device showed a baseline mean WASO of 77.7 (SD 52.6) minutes for elinzanetant versus 61.7 (SD 27.6) minutes for placebo, with an overall treatment effect again favoring elinzanetant (LS mean difference: -17.7 minutes; unadjusted 95% CI: -27.1, -8.2). Sleep Diary data similarly favored elinzanetant, with a baseline mean WASO of 42.4 (SD 25.7) minutes versus 45.5 (SD 25.6) minutes for placebo and an overall treatment effect of -8.1 minutes (unadjusted 95% CI: -14.2, -1.9).

Context and implications

The consistency of WASO reductions across in-lab PSG, home-based device monitoring, and patient-reported diary data strengthens the signal for elinzanetant's effect on sleep disturbance in this population.

The authors noted that these findings are consistent with previously reported improvements in sleep disturbances from the OASIS trials. While the analysis is exploratory in nature given its post hoc design, the convergence of results across 3 distinct measurement approaches supports elinzanetant's potential utility in addressing sleep disturbances in menopausal women with VMS.

Reference:

Soares CN, Zammit G, Nappi RS, et al. Consistency in effect of elinzanetant on wakefulness after sleep onset across subjective and objective measures: post hoc analysis of the Phase II NIRVANA pilot study in postmenopausal women with sleep disturbance. Poster. Presented at: SLEEP 2026. June 14-17, 2026. Baltimore, Maryland.