Night sweats are one of the most common reasons menopausal sleep falls apart, and a new analysis suggests that treating the flushes may repair the nights. Preliminary real-world results from the phase 4 OPTION-VMS study, presented at the International Menopause Society 20th World Congress on Menopause in October 2026, show that the non-hormonal medicine fezolinetant improved both hot flushes and sleep measures, including an average of 2.6 fewer nighttime awakenings at 12 weeks.

This is the first real-world study to combine women’s own reports of sleep with objective, wearable-derived sleep data for this drug. The findings are promising but preliminary: they were presented at a scientific congress rather than published in a peer-reviewed journal, and the study design cannot prove that the medicine itself caused the sleep improvements. This article explains what was found, what it means for women weighing non-hormonal options, and where fezolinetant sits in UK clinical practice.

Key points

  • Fezolinetant (Veoza in the UK) is a once-daily, non-hormonal tablet licensed for moderate to severe hot flushes and night sweats. It works by blocking neurokinin 3 receptors in the brain’s temperature control centre.
  • The OPTION-VMS phase 4 study found statistically significant improvements in bothersome hot flushes and night sweats at 4, 8 and 12 weeks, exceeding the threshold for a minimal clinically important difference.
  • For the first time, objective real-world sleep data showed significant improvements: patient-reported sleep disturbance scores moved from the mild-disturbance range into the no-disturbance range by week 4, and wearable actigraphy showed fewer nighttime awakenings, less wakefulness after sleep onset and better sleep efficiency.
  • The study was observational and was not designed to compare fezolinetant against other treatments. Sleep gains may follow from fewer night sweats rather than a direct sleep effect.
  • In the UK, fezolinetant has been licensed since December 2023 and NICE issued final draft guidance in March 2026 recommending it for NHS England for patients for whom HRT is unsuitable or who prefer not to take it. Liver function monitoring is required before and during treatment.

Why do night sweats disrupt sleep in menopause?

Vasomotor symptoms, the clinical term for hot flushes and night sweats, are the most common symptoms of the menopause. Night sweats wake women repeatedly, fragmenting sleep even when the total hours in bed look adequate. Astellas reports, citing the menopause sleep literature, that sleep disturbances affect an estimated 40 to 60 percent of menopausal women, and that women with moderate to severe hot flushes are almost three times more likely to report frequent nighttime awakenings than women without hot flushes.

The mechanism runs through the brain’s thermostat. Before menopause, oestrogen and a brain protein called neurokinin B are kept in balance in the hypothalamus, the region that regulates body temperature. As oestrogen falls in menopause, that balance is disrupted and the temperature control centre narrows its tolerance: small temperature shifts trigger the sweating and flushing response that wakes a woman drenched at 3 a.m.

Broken sleep does not stay in the bedroom. Persistent sleep loss can feed daytime fatigue, low mood and anxiety, and difficulty concentrating, which is why sleep complaints deserve the same clinical attention as the flushes themselves. If low mood or anxiety accompany your menopause transition, our guide to perimenopause, anxiety and low mood explains what good assessment and care look like.

What is fezolinetant and how does it work?

Fezolinetant is a non-hormonal, selective neurokinin 3 (NK3) receptor antagonist. It blocks neurokinin B from binding on kisspeptin/neurokinin/dynorphin (KNDy) neurons in the hypothalamus, restoring balance in the temperature control centre and reducing the frequency and severity of hot flushes and night sweats. It is taken as a 45 mg tablet once daily and contains no hormones.

The medicine is currently approved in 50 countries. In Great Britain it is marketed as Veoza, licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2023 for moderate to severe vasomotor symptoms associated with the menopause, and available on private prescription from January 2024.

Its NHS position has moved forward. In final draft guidance published on 11 March 2026, NICE recommended fezolinetant for use on the NHS in England for patients for whom hormone replacement therapy (HRT) is not suitable or who do not wish to take it. HRT may be medically unsuitable, for example, after deep vein thrombosis or pulmonary embolism. NICE did not recommend the drug for people with current breast cancer, other oestrogen-dependent cancers or liver disease, and said women who have previously had these cancers and completed treatment should have an individual risk assessment before treatment is considered. Liver function monitoring is required before starting treatment and regularly thereafter.

The breast cancer caveat matters: women with a history of hormone-sensitive cancer need a careful, individualised conversation with their clinician, and keeping up with routine surveillance remains important. Our honest guide to breast screening and what to expect covers the screening pathway calmly.

What did the OPTION-VMS study find for hot flushes and night sweats?

OPTION-VMS (NCT06049797) is a phase 4, longitudinal, observational study of women aged 40 to 75 with confirmed menopausal hot flushes and night sweats who were prescribed a non-hormonal therapy by their healthcare provider in routine clinical practice. The preliminary analysis of women treated with fezolinetant 45 mg was presented as an oral presentation at the IMS congress by lead author Prof. Marla Shapiro of the University of Toronto.

The headline efficacy finding: women treated with fezolinetant had statistically significant improvements from baseline in bothersome vasomotor symptoms at week 12, the study’s primary endpoint, measured by the MENQOL vasomotor symptoms domain. Improvements were already visible at weeks 4 and 8 (p less than 0.001 for all time points), and the reductions exceeded the prespecified threshold for a minimal clinically important difference, meaning the change was large enough to matter in daily life.

On safety, no new signals were seen. Hepatic laboratory findings were mild and infrequent: two cases of non-serious mildly elevated liver tests, none of which led to treatment or study discontinuation. This is consistent with the medicine’s known profile: liver monitoring is part of its licensed use, with blood tests before starting, monthly for the first three months, and at months six and nine in US labelling, and monitoring before treatment and periodically thereafter under the UK position.

An important design note: OPTION-VMS included women prescribed other non-hormonal therapies too, such as SSRIs, SNRIs, gabapentin and oxybutynin, but the study was not designed to assess differences between treatment groups. So these results tell us how women on fezolinetant did in routine practice, not that fezolinetant outperformed alternatives.

Does fezolinetant improve menopause sleep?

This is where the new analysis breaks ground. It is the first real-world analysis to pair women’s reported sleep with objective sleep data from a medical-grade wearable, giving a fuller picture than questionnaires alone. Both sets of measures improved significantly at weeks 4, 8 and 12.

Patient-reported sleep. Sleep disturbance scores, measured with the PROMIS Sleep Disturbance Short Form 8b, improved from the mild sleep disturbance range at baseline into the no-sleep-disturbance range by week 4, with improvements maintained through week 12 (p less than 0.001). The full release is available at Astellas’ newsroom.

Objective sleep. Actigraphy-derived measures, including wakefulness after sleep onset, sleep efficiency, sleep latency and nighttime awakenings, improved significantly at all three time points (p less than 0.05). By week 12, women treated with fezolinetant averaged 2.6 fewer nighttime awakenings than at baseline.

These sleep results were described as the first real-world objective sleep outcomes data for the medicine, and the analysis is complemented by further real-world studies presented at the same congress: GRACE, a 24-week observational study in Germany, and ADELE-AU, an Australian study whose primary objective is real-world sleep disturbances after 12 weeks of treatment.

Does this mean fezolinetant is a sleep medicine? Not exactly. The likeliest explanation is indirect: fewer night sweats mean fewer awakenings, which lets sleep consolidate. Whether the drug has any direct effect on sleep architecture cannot be separated out in an observational study without a control arm, and a conservative reading is that treating vasomotor symptoms removes a major barrier to sleeping through the night. That is still a meaningful clinical benefit for women whose nights are currently broken by flushes.

Who might be considered for fezolinetant in the UK?

Fezolinetant sits in the second-line space. UK guidance is clear that HRT remains the primary treatment for bothersome vasomotor symptoms: NICE’s guideline on menopause identification and management (NG23) states that HRT is the first option, with menopause-specific cognitive behavioural therapy (CBT) to be considered as an add-on or when HRT is unsuitable or not wanted.

Fezolinetant becomes relevant when HRT is unsuitable or when a woman prefers not to take it. That includes women with contraindications such as a history of venous thromboembolism or certain cancers, women taking medicines that interact with HRT, and women who simply do not want hormonal treatment. NICE’s March 2026 final draft guidance also noted the drug may be chosen following a clinical risk assessment in some cases of diabetes or heart disease.

Treatment is not a fit-and-forget prescription. Liver function tests are required before starting and periodically during treatment, and the medicine should not be used in people with cirrhosis or liver disease. As with any prescription decision, the benefits for an individual’s symptom burden have to be weighed against monitoring requirements and alternatives, which is a conversation for a GP or menopause specialist, not a pharmacy queue.

What are the limitations of this data?

A clinical reading needs the caveats alongside the headlines.

First, this is a preliminary analysis presented at a congress, not a peer-reviewed publication. Congress presentations carry the risk that later, fuller analyses report slightly different numbers.

Second, OPTION-VMS is observational. Women were not randomised, there is no placebo or comparator arm for the sleep outcomes, and improvements are measured against each woman’s own baseline. Real-world designs capture routine practice faithfully, but they cannot prove causation the way a randomised trial can.

Third, the analysis was reported through an Astellas press release based on the congress abstract. The lead presenter is Prof. Marla Shapiro, and the framing comes from the medicine’s developer, so independent replication, including the ongoing GRACE and ADELE-AU studies, will strengthen or qualify these findings.

Fourth, the sleep benefit is most plausibly secondary to fewer vasomotor symptoms. That does not make it less real for women experiencing it, but it means fezolinetant should not be reframed as a general sleep aid.

Finally, sleep is one piece of a wider menopause picture. Women thinking about longer-term brain and cognitive health can read our summary of the latest research in menopause and brain health, which covers what a large blood protein study did and did not show about dementia risk.

What else helps menopause sleep problems?

For many women, the most effective route to better sleep still runs through the underlying symptoms.

Hormone replacement therapy. Where suitable, HRT is the first-line treatment for bothersome hot flushes and night sweats under NICE NG23, and controlling the flushes often restores sleep as a consequence. A GP can discuss the benefits and risks of different types and doses, tailored to age, circumstances and risk factors.

Cognitive behavioural therapy. NICE NG23 suggests considering CBT for vasomotor symptoms in addition to HRT or when HRT is not advised or not wanted, and considering CBT for people who have sleep problems in association with these symptoms. Access varies by area and waiting lists can be long, but CBT for insomnia techniques are among the better-evidenced non-drug approaches.

Sleep hygiene foundations. The standard measures still matter: a regular sleep schedule, a cool and dark bedroom, limiting caffeine after midday and alcohol in the evening, and keeping screens out of the final hour before bed. These will not stop a genuine hot flush, but they remove the avoidable causes of fragmentation.

See your GP if sleep disruption is affecting daytime functioning, if you snore heavily or have breathing pauses (which suggest sleep apnoea), if low mood or anxiety are prominent, or if hot flushes remain severe despite treatment. A clinician can review whether HRT, a non-hormonal medicine such as fezolinetant, or referral to a menopause service is most appropriate.

Frequently asked questions

Does fezolinetant help menopause sleep problems?

Preliminary real-world data from the OPTION-VMS study, presented in October 2026, found that fezolinetant improved both patient-reported and objectively measured sleep in women with bothersome hot flushes and night sweats. Patient-reported sleep disturbance scores moved into the no-disturbance range by week 4, and wearable data showed an average of 2.6 fewer nighttime awakenings by week 12. The benefit is most plausibly explained by fewer night sweats rather than a direct sleep effect.

How quickly does fezolinetant work for night sweats?

In the OPTION-VMS real-world analysis, statistically significant improvements in bothersome hot flushes and night sweats were observed as early as week 4, and were maintained at weeks 8 and 12, with the reduction exceeding the minimal clinically important difference.

Is fezolinetant available on the NHS?

Fezolinetant (Veoza) has been licensed in Great Britain since December 2023 and available on private prescription since January 2024. In final draft guidance published on 11 March 2026, NICE recommended it for use on the NHS in England for patients for whom HRT is not suitable or who do not wish to take it. Individual GP prescribing depends on local commissioning arrangements.

What monitoring does fezolinetant require?

Liver function blood tests are needed before starting treatment and periodically during treatment, because the medicine can affect the liver. It should not be used in people with cirrhosis or liver disease, and it interacts with certain medicines including some CYP1A2 inhibitors, so a full medication review is part of starting treatment.

Can fezolinetant be used after breast cancer?

Clinical studies did not include women with current breast cancer or oestrogen-dependent cancers, and NICE’s draft guidance did not recommend it for those groups. Women who have had breast cancer and completed treatment should have an individual risk assessment with their clinician before it is considered.

What is the best non-hormonal treatment for menopause sleep?

There is no single best option. Where HRT is unsuitable or unwanted, non-hormonal approaches include fezolinetant, certain antidepressants used off-label for hot flushes, and CBT for sleep and vasomotor symptoms. The right choice depends on the woman’s symptoms, medical history and preferences, and is best made with a clinician.

This article is for information only and is not medical advice. If you are considering treatment for menopause symptoms, speak to your GP or a menopause specialist.