Fiona Baker, PhD, details elinzanetant's effectiveness on wakefulness after sleep onset in postmenopausal women

Elinzanetant (Lynkuet) reduced wakefulness after sleep onset (WASO) compared with placebo across all 3 measurement modalities, including polysomnography (PSG), a contactless home-monitoring device, and patient-reported sleep diary, in a post hoc analysis of the phase 2 NIRVANA trial (NCT06112756) presented at the SLEEP 2026 Annual Meeting in Baltimore, Maryland.

The NIRVANA trial randomized 110 postmenopausal women with PSG-confirmed WASO of at least 30 minutes and at least 20 moderate-to-severe vasomotor symptoms (VMS) per week to elinzanetant 120 mg (n = 55) or placebo (n = 55) once daily for 12 weeks. PSG assessments were conducted at baseline, week 4, and week 12 (2 consecutive nights per timepoint). The Sleepiz One+, a contactless home-monitoring device, was used in a subset of participants (elinzanetant: n = 33, placebo: n = 33), whereas sleep diary data were collected nightly across all participants.

Consistent signal across measurement modalities

Fiona Baker, PhD, director, Human Sleep Research Program, SRI International, and one of the study authors, emphasized that the multimodal design was central to the trial's contribution.

"NIRVANA was a novel study in that it used 3 different measurements of sleep, [which is] quite unique," she said. "It didn't only look at self-reported sleep disturbance in women who had severe or moderate vasomotor symptoms and sleep disturbance."

Across all 3 modalities, overall treatment effects over 12 weeks favored elinzanetant. By PSG, baseline mean WASO was 74.7 minutes (SD 34.8) for elinzanetant and 82.8 minutes (SD 34.4) for placebo.

“Overall treatment effect favored elinzanetant (least squares [LS] mean difference: -10.1 minutes; unadjusted 95% confidence interval [CI]: -18.5, -1.6),” the authors wrote.

The Sleepiz One+ showed a larger numerical separation, with a baseline mean WASO of 77.7 minutes (SD 52.6) versus 61.7 minutes (SD 27.6) for placebo, and an LS mean difference of −17.7 minutes (unadjusted 95% CI: −27.1, −8.2). Sleep diary data yielded an LS mean difference of −8.1 minutes (unadjusted 95% CI: −14.2, −1.9), with baseline mean WASO of 42.4 minutes (SD 25.7) in the elinzanetant group and 45.5 minutes (SD 25.6) in the placebo group.

Baker noted that the focus on WASO was clinically deliberate.

"One of the main complaints that women will report when they're going through menopause is that they are waking up a lot during the night and having trouble going back to sleep, so that was the main focus of the NIRVANA trial."

Extending evidence from the OASIS trials

Baker described NIRVANA as building on a foundation established by the prior OASIS trials, which demonstrated elinzanetant's efficacy on patient-reported sleep outcomes.

"The NIRVANA study really extends a lot of what we know about how elinzanetant is working in women who suffer from moderate to severe vasomotor symptoms associated with menopause," she said, adding that results were consistent regardless of how sleep disturbance was measured: "No matter how we measure sleep disturbance with menopause, the NIRVANA trials are showing that elinzanetant was effective."

The abstract notes that findings are consistent with previously reported improvements in sleep disturbances from the OASIS trials.

Reference:

Joffe H, Soares Cl, Zammit G, et al. Effects of elinzanetant on wakefulness after sleep onset in postmenopausal women: Post hoc analysis of NIRVANA study. Abstract. Presented at: SLEEP 2026. June 14-17, 2026. Baltimore, Maryland.