Elinzanetant in postmenopausal women with sleep disturbance: results from the randomized, phase II NIRVANA study.

In 30 seconds

The phase II NIRVANA randomised trial assessed elinzanetant versus placebo in 110 postmenopausal women aged 40–65 years with moderate-to-severe vasomotor symptoms and objectively measured sleep disturbance. Over 12 weeks, elinzanetant was estimated to reduce polysomnographic wakefulness after sleep onset (WASO) at Week 4 versus placebo by 22.50 minutes (least-squares mean difference −22.50 minutes; 90% CI −35.47 to −9.52). At Week 12, the estimated between-group difference in WASO was minimal. Analyses across the full study period suggested improvements in several sleep measures, including diary and home-monitoring outcomes.

Key findings

• At Week 4, the estimated PSG WASO difference favored elinzanetant by −22.50 minutes versus placebo (90% CI −35.47 to −9.52).
• At Week 12, the estimated PSG WASO difference was −0.94 minutes (90% CI −13.96 to 12.09), indicating minimal group difference.
• Post hoc modelling across 12 weeks favored elinzanetant for several PSG measures, including WASO, total sleep time, sleep efficiency, and number of awakenings.
• Sleep Diary and Sleepiz One+ outcomes also showed effects favoring elinzanetant for WASO and awakenings across 12 weeks.

Why it matters

Sleep disturbance is a clinically relevant burden associated with menopausal vasomotor symptoms. This trial examined sleep using objective PSG, daily diaries, and contactless home monitoring, providing complementary measures of treatment response. The early WASO result and broader sleep-continuity signals are of interest, but the minimal estimated Week 12 PSG difference underscores that effects may vary by time point and outcome.

What to keep in mind

The study was a phase II trial with 110 participants and 12 weeks of follow-up. Several findings across the full period came from post hoc modelling, and the Week 12 PSG WASO difference was minimal.