Sleepless nights, clammy sheets and burning cheeks drain energy and confidence; a new approach promises calmer days for millions.
After years of relying mainly on hormones, women now have another way to tackle intense temperature swings that derail work, sleep and social life. A newly authorised tablet targets the brain’s thermostat rather than topping up oestrogen.
What the FDA has approved
The US Food and Drug Administration has authorised Lynkuet (elinzanetant) for moderate to severe hot flushes and night sweats linked to menopause. The green light came on 24 October 2025, with Bayer planning a US launch in November 2025.
Regulators in the UK approved the medicine earlier in July, making the Medicines and Healthcare products Regulatory Agency the first to sign it off. Approvals have also followed in Australia, Canada and Switzerland. In Britain, private prescriptions are already possible; wider NHS access is expected, but no date has been confirmed.
Lynkuet (elinzanetant) won FDA approval on 24 October 2025 for moderate to severe menopausal hot flushes and night sweats.
How the pill works
Unlike hormone replacement therapy (HRT), elinzanetant does not supply oestrogen or progesterone. It blocks neurokinin receptors (NK1 and NK3) in brain regions that help regulate body temperature. By damping the overactive signalling that follows the natural fall in oestrogen, the drug aims to stabilise the “thermostat” and reduce flush frequency and intensity.
A brief primer on the science
During and after menopause, changing hormone levels can overstimulate a network of neurons often called KNDy neurons. These cells use neurokinin signals and feed into temperature control circuits. Blocking NK1/NK3 receptors modulates that signalling, which can calm vasomotor symptoms without adding hormones.
Who might benefit
The treatment targets women whose vasomotor symptoms are moderate to severe—those who flush often, wake drenched, or lose sleep and productivity as a result. Because it is non-hormonal, it may suit people who cannot, or would rather not, take HRT.
- You may consider discussing it if hot flushes disrupt sleep or daily activities several times per week.
- You prefer a non-hormonal path or have reasons to avoid oestrogen-based therapy.
- You tried lifestyle measures and still struggle with frequent or intense symptoms.
- You want an option with a defined neurological mechanism rather than hormone replacement.
Pregnancy remains an absolute no-go. Women who are pregnant, trying to conceive or not using reliable contraception should not take this medicine.
What the evidence shows
FDA approval rests on three Phase III trials—OASIS 1, 2 and 3—enrolling more than 1,400 women. In OASIS 1 and 2, the drug met co‑primary endpoints by weeks 4 and 12, cutting both the number and severity of moderate to severe hot flushes. In a separate analysis, over 80% of participants on treatment achieved at least a 50% reduction in hot-flush frequency by week 26.
| Time point | Key outcome |
|---|---|
| Week 4 | Significant reduction in frequency and severity of hot flushes |
| Week 12 | Improvements sustained across both measures |
| Week 26 | Over 80% recorded at least 50% fewer hot flushes in one analysis |
Safety, side effects and who should avoid it
As with any prescription medicine, benefits sit alongside risks. Reported side effects include headache, fatigue, sleepiness, stomach pain, rash, diarrhoea and muscle spasms. Some people recorded raised liver enzyme results on blood tests. Those with a history of seizures face added risk and need tailored advice.
Do not use during pregnancy. Discuss seizure history and arrange liver blood tests before and during treatment as advised.
Speak to your GP or menopause specialist about your history, current medicines and any liver concerns. You may need periodic blood tests to check liver function. Report new neurological symptoms promptly, especially if you live with a seizure disorder.
Access and timing for patients
In the United States, Bayer plans to place Lynkuet on the market in November 2025. UK patients can already obtain it privately, while an NHS listing remains pending. Health systems in Australia, Canada and Switzerland have also granted approvals, though local availability and reimbursement rules differ by region.
Pricing and insurance coverage have not been set out publicly. Patients often start by confirming eligibility with their GP, checking any formulary status, and weighing costs against potential gains in sleep, work performance and daily comfort.
What this could mean for you
Many women gain strong relief with HRT, especially when started near the onset of symptoms and in those without contraindications. A non-hormonal pill gives another route for those who cannot or do not wish to use hormones. If your symptoms exhaust you, track them for two weeks—note frequency, severity, triggers and night-time awakening—then book a conversation with your clinician.
- Bring a symptom diary and a list of medicines and supplements.
- Ask about baseline liver tests and any follow‑up schedule.
- Discuss pregnancy prevention if relevant.
- Set clear goals: fewer flushes, better sleep, or improved daytime function.
Other non-hormonal choices to discuss
Several established options may help vasomotor symptoms. Selective serotonin reuptake inhibitors and serotonin–noradrenaline reuptake inhibitors (for example, paroxetine or venlafaxine) can reduce flushes for some women. Gabapentin and oxybutynin are sometimes used, though side‑effect profiles vary. Clonidine sees occasional use but tends to help modestly. Cognitive behavioural therapy can support sleep and coping. Lifestyle steps—layered clothing, fans at the bedside, paced breathing, and easing back on alcohol, spicy food and caffeine—often make a noticeable difference.
Key numbers and takeaways
What to remember this week
- 24 October 2025: FDA approval for Lynkuet (elinzanetant) in moderate to severe hot flushes and night sweats.
- Trials enrolled 1,400+ women; benefits appeared by week 4 and held at week 12.
- By week 26, more than 80% achieved at least 50% fewer hot flushes in one analysis.
- Non-hormonal approach may suit those who cannot or prefer not to use HRT.
- Pregnancy contraindicated; monitor liver enzymes; discuss seizure history.
A hormone‑free option now sits alongside HRT, giving women and clinicians more room to tailor treatment.
If you plan ahead, you can test what works without losing months to trial and error. Combine a treatment plan with practical heat‑management tactics, set review dates with your clinician and adjust based on clear goals. The aim is simple: fewer flushes, better sleep and steadier days.
Finally a non-hormonal option! If 80% hit 50% fewer hot flushes by week 26, that’s huge. Curious how it performs outside trials and whether sleep quality actually improves, not just the flush count.
Blocking NK1/NK3 sounds clever, but what about long‑term safety and raised liver enzimes? How often do you need blood tests—monthly or quarterly? And is this going to be pricy without solid insurance coverage?