Elinzanetant reduces wakefulness after sleep onset in postmenopausal women with sleep disturbance
Elinzanetant 120 mg reduced polysomnography-measured wakefulness after sleep onset (WASO) by an estimated 22.5 minutes more than placebo at Week 4 (90% CI: -35.47, -9.52). Post hoc analysis across 12 weeks suggested improvements in sleep continuity, supported by subjective and objective multimodal measures.
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Elinzanetant reduces wakefulness after sleep onset in postmenopausal women with sleep disturbance The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 44/100 (low).
The Claim
Elinzanetant reduces wakefulness after sleep onset in postmenopausal women with sleep disturbance
This conclusion is most relevant to: Postmenopausal women (N=110; aged 40-65 years) with moderate-to-severe vasomotor symptoms (≥20/week) and sleep disturbance (PSG WASO ≥30 min).
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸Elinzanetant in postmenopausal women with sleep disturbance: results from the randomized, phase II NIRVANA study. (Sleep, 2026) —
How It Works
The proposed biological pathway:
- ▸Elinzanetant is a dual NK-1/NK-3 receptor antagonist
- ▸Blocks neurokinin receptors involved in thermoregulation and sleep-wake regulation
- ▸Reduces vasomotor symptoms and associated sleep disruption
- ▸Leads to improved sleep continuity and reduced wakefulness after sleep onset
Who Might Benefit
Evidence fit by population:
- ▸Postmenopausal women (N=110; aged 40-65 years) with moderate-to-severe vasomotor symptoms (≥20/week) and sleep disturbance (PSG WASO ≥30 min)
Recommended Dose
120 mg daily
Limitations & Caveats
Important context when interpreting this evidence:
- ▸Primary endpoint (PSG WASO at Week 12) did not show significant group difference (LS-mean difference -0.94 min, 90% CI: -13.96 to 12.09)
- ▸Post hoc analyses were exploratory and not pre-specified, increasing risk of type I error
- ▸Small sample size (N=110) limits generalizability
Frequently Asked Questions
What is elinzanetant?▼
Elinzanetant is a dual neurokinin-1 and neurokinin-3 receptor antagonist being studied for menopausal sleep disturbances and vasomotor symptoms.
How was sleep measured in the NIRVANA study?▼
Sleep was measured using polysomnography (PSG), daily Sleep Diaries, and a contactless home-monitoring device (Sleepiz One+).
Did elinzanetant improve sleep at 12 weeks?▼
The primary PSG WASO endpoint at Week 12 did not show a significant difference versus placebo, but post hoc analyses across the full 12-week period suggested improvements in multiple sleep parameters.
Who was eligible for the NIRVANA study?▼
Postmenopausal women aged 40-65 years with moderate-to-severe vasomotor symptoms (≥20 per week) and objective sleep disturbance (PSG WASO ≥30 minutes).
References
- 1.Baker FC, Joffe H, Soares CN, Maki PM, Bajbouj M, Nappi RE, Zammit G, Caetano C, Krahn U, Shalhoub H, Kramer F, Radcliffe HS, Seitz C. “Elinzanetant in postmenopausal women with sleep disturbance: results from the randomized, phase II NIRVANA study..” Sleep, 2026. PMID: 42520241 DOI: 10.1093/sleep/zsag208