Supplements

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.

Last updated: Aug 11, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Elinzanetant in postmenopausal women with sleep disturbance: results from the randomized, phase II NIRVANA study.

observational

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 · Sleep (2026)

Participants: N/A
Duration: 12 weeks
Intervention: Elinzanetant 120 mg daily for 12 weeks
Outcome: Polysomnography wakefulness after sleep onset (WASO), total sleep time, sleep efficiency, latency to persistent sleep, number of awakenings, arousal index, % Stage N2 sleep; daily Sleep Diary; contactless home-monitoring (Sleepiz One+)
Effect Size: LS-mean difference in PSG WASO at Week 4: -22.50 minutes (90% CI: -35.47, -9.52)
Population: Postmenopausal women (N=110; aged 40-65 years) with moderate-to-severe vasomotor symptoms (≥20/week) and sleep disturbance (PSG WASO ≥30 min)

Result:

PubMed: 42520241DOI: 10.1093/sleep/zsag208

Mechanism Graph

Elinzanetant is a dual NK-1/NK-3 receptor antagonist
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Blocks neurokinin receptors involved in thermoregulation and sleep-wake regulation
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Reduces vasomotor symptoms and associated sleep disruption
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Leads to improved sleep continuity and reduced wakefulness after sleep onset

Limitations

  • ⚠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).

Products

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References

  1. 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
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.