Many women wake sweating through the night and dreading daytime surges of heat. A fresh option could change the routine.
US regulators have authorised a non-hormonal pill for troublesome menopause symptoms, offering an alternative to hormone therapy and a new route to steadier sleep.
What’s new about Lynkuet
The Food and Drug Administration has approved Lynkuet (elinzanetant) to treat moderate to severe hot flushes and night sweats linked to menopause. The green light arrived on 24 October 2025, with a United States launch planned for November. The United Kingdom approved the medicine earlier in July, with private prescriptions already possible and NHS availability expected to follow. Regulators in Australia, Canada and Switzerland have also granted approval.
For many women who avoid or cannot take HRT, Lynkuet introduces a hormone‑free path to relief from disruptive vasomotor symptoms.
- Who it’s for: women with moderate to severe hot flushes and night sweats during peri‑ or post‑menopause.
- What it is: a once‑daily, non‑hormonal tablet (elinzanetant) targeting brain receptors involved in temperature control.
- When it’s coming: US launch expected November 2025; UK available privately now; NHS date to be confirmed.
- Where else: approvals already issued in Australia, Canada and Switzerland.
- Why it matters: offers another clinically tested option beyond hormone therapy.
How the pill works
Lynkuet does not replace oestrogen or progesterone. Instead, it blocks neurokinin 1 and neurokinin 3 receptors in the brain. These receptors help regulate the body’s thermostat. During menopause, hormonal shifts can make that thermostat overshoot, triggering sudden heat surges and sweats. By damping the signalling on those receptors, the drug steadies temperature control without using hormones.
When relief may begin
Phase III trials showed measurable improvements by week 4, with further gains by week 12. In pooled analyses, more than 80% of participants achieved at least a 50% reduction in hot‑flush frequency by week 26. Many women also reported fewer night awakenings as symptoms eased.
Trials OASIS‑1, OASIS‑2 and OASIS‑3 enrolled over 1,400 women and met key goals for cutting both the number and severity of hot flushes.
Who might benefit—and who should not take it
Lynkuet may suit women who cannot use hormone replacement therapy because of medical history, medication interactions, or personal preference. It can also be considered by those who tried lifestyle changes without adequate relief.
People who should avoid it
- Those who are pregnant or planning pregnancy; the medicine can harm a pregnancy.
- People with a history of seizures; the label warns of seizure risk.
- Anyone with known liver disease or abnormal liver tests, unless a clinician judges benefits outweigh risks.
Doctors may order liver blood tests before starting treatment and at intervals afterwards. Because the medicine can cause sleepiness, take care with driving and machinery until you know how you respond.
Safety and side effects
The most commonly reported side effects include headache, fatigue, drowsiness, stomach pain, rash, diarrhoea and muscle spasms. Most events were mild to moderate in the trials. The label carries cautions about central nervous system effects, daytime impairment, increased liver blood test values, pregnancy loss risk, and seizures in susceptible individuals. Speak with your GP or menopause specialist about other medicines you take, including over‑the‑counter products and herbal remedies, to check for interactions.
Evidence in numbers
| Measure | Result |
|---|---|
| Participants across Phase III OASIS trials | Over 1,400 menopausal women with moderate to severe symptoms |
| Primary goals at week 4 and week 12 | Reduced number and severity of hot flushes versus placebo |
| Week 26 response | More than 80% achieved at least a 50% cut in flush frequency |
| Common side effects | Headache, fatigue, sleepiness, abdominal pain, rash, diarrhoea, muscle spasms |
| Key warnings | Liver enzyme elevations, pregnancy loss risk, seizure risk in susceptible people |
Availability and access
In the US, Bayer plans to make Lynkuet available from November 2025. The company has not announced pricing. Health insurers will set coverage policies after the launch. In the UK, private prescriptions are already possible; an NHS listing is anticipated, with timing to be confirmed. Outside these markets, launch schedules will vary by country despite regulatory approvals already granted.
How it compares with other options
Hormone replacement therapy remains a strong option for many, especially when no contraindications exist. Some women prefer non‑hormonal routes. Alternatives include certain antidepressants (for example, SSRIs/SNRIs), gabapentin and clonidine, which can blunt hot flushes in some cases. Sleep‑focused cognitive behavioural therapy can support night‑time symptoms. Lifestyle measures—cool bedrooms, layered clothing, moderating alcohol and spicy foods, and paced breathing—often help, though relief ranges widely.
What this could mean day to day
Consider a woman who experiences 10 flushes daily. Trial data suggest that by six months, a typical responder might see that number halved. Fewer nocturnal sweats can improve sleep continuity and energy levels. Those shifts often ripple into better mood, clearer thinking and more stable workdays.
Questions to ask your clinician
- Do my symptoms count as moderate to severe, and is a non‑hormonal approach suitable?
- How would Lynkuet interact with my current medicines or migraine, seizure or liver history?
- What monitoring do I need, and when should liver blood tests be done?
- How soon might I notice changes, and what should I do if side effects appear?
- Could I combine this with sleep strategies or therapy to tackle night‑time awakenings?
Extra context to help you decide
Vasomotor symptoms—hot flushes and night sweats—stem from a narrowed “thermal neutral zone” in the brain’s hypothalamus. Small changes in core temperature trigger outsized responses, producing sudden waves of heat, flushing and sweat. Blocking NK1/NK3 pathways widens that neutral zone, which is why a non‑hormonal blocker can settle symptoms without adding oestrogen or progestogen.
If you start treatment, keep a brief symptom diary for four to six weeks. Note the number of flushes, night awakenings, triggers and how you feel the next day. This record helps your clinician judge whether the dose works for you and whether to continue. If drowsiness occurs, consider taking the tablet in the evening after discussing timing with your prescriber, and avoid driving until you feel fully alert.
Blocking NK1/NK3 sounds promising, but what about long‑term safety beyond 26 weeks? Any open‑label extension data on liver enzyme elevations or seizure risk, especialy in folks with borderline LFTs? Kinda wary of “daytime impairment” warnings.