Hot flashes are one of the most disruptive symptoms of menopause, affecting sleep, mood, work, and overall quality of life. For decades, hormone therapy has been the most effective treatment – but it isn’t right for everyone. That’s why the FDA’s approval of LYNKUET (elinzanetant) in late 2025 has generated so much interest. It’s a non‑hormonal, once‑daily medication designed specifically to reduce moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes.

If you’re exploring treatment options or simply trying to understand what this new medication offers, we’ll break down the science, clinical trials, safety considerations, and what patients should keep in mind when discussing LYNKUET with their healthcare provider.

What LYNKUET Is – and Why It Matters

LYNKUET is the first medication of its kind to target the neurokinin pathways in the brain that regulate body temperature. During menopause, declining estrogen levels cause certain neurons – called KNDy neurons – to become overactive. This overactivity disrupts the body’s internal thermostat, triggering sudden waves of heat, sweating, and flushing.

Instead of replacing estrogen, LYNKUET works by blocking two key receptors on these neurons: NK1 and NK3. By calming this overactive signaling, the medication helps restore temperature stability. For people who cannot or prefer not to take hormone therapy, this offers a meaningful new option.

LYNKUET is taken once daily at bedtime, with or without food. The recommended dose is 120 mg, delivered as two 60 mg capsules that must be swallowed whole.

How LYNKUET Was Studied

The FDA approval was based on data from the OASIS clinical trial program, which included three large, well‑designed studies: OASIS‑1, OASIS‑2, and OASIS‑3. Together, these trials enrolled more than 1,420 women across 21 countries, including the United States, Canada, and several European nations.

All participants were experiencing moderate to severe hot flashes, and the studies were randomized, double‑blind, and placebo‑controlled – the gold standard for evaluating new medications.

The first two trials focused on how well LYNKUET reduced the frequency and severity of hot flashes over the first 12 weeks. The third trial followed participants longer to assess safety and durability of benefit.

Across all three studies, the results were consistent: LYNKUET significantly reduced both the number and intensity of hot flashes compared to placebo. Many participants saw improvements as early as Week 4, with continued progress through Week 12 and beyond. Importantly, the benefits were similar across different ages, races, and geographic regions, suggesting the medication works broadly across diverse populations.

What Patients Should Know About Safety

Like all medications, LYNKUET comes with potential side effects and safety considerations. Most are mild, but some require monitoring or special precautions.

Common Side Effects

The most frequently reported side effects in clinical trials included:

• Headache
• Fatigue
• Dizziness
• Sleepiness or drowsiness

These effects were generally mild to moderate and tended to improve over time.

Liver Monitoring Is Required

One of the most important safety considerations is the potential for liver enzyme elevations. While serious liver injury was rare, the FDA requires:

• A baseline liver function test before starting LYNKUET
• A repeat test at 3 months

Patients should not begin treatment if their liver enzymes or bilirubin levels are significantly elevated.

It’s also important to watch for symptoms of liver problems, such as:

• Dark urine
• Yellowing of the skin or eyes
• Severe fatigue
• Upper‑right abdominal pain

If any of these occur, patients should contact their healthcare provider immediately.

Not Safe During Pregnancy

LYNKUET can cause pregnancy loss or stillbirth if taken during pregnancy. Because of this, individuals who could become pregnant must have pregnancy ruled out before starting the medication. LYNKUET should not be used at any point during pregnancy.

CNS Effects and Driving Precautions

Because LYNKUET can cause drowsiness or slowed reaction time, patients should avoid driving or operating heavy machinery until they know how the medication affects them. Taking it at bedtime helps minimize daytime sleepiness, but caution is still recommended.

Seizure Risk

People with a history of seizures may be at increased risk when taking LYNKUET. This doesn’t automatically rule out the medication, but it does require a careful discussion with a healthcare provider.

What to Expect When Starting LYNKUET

Before starting treatment, patients should have a thorough conversation with their clinician about:

• Current medications (to avoid interactions)
• Liver health history
• Pregnancy status
• Sleep patterns
• Any history of seizures

During treatment, it’s important to monitor how the medication affects energy levels, sleepiness, and overall well‑being. Most side effects are manageable, but any concerning symptoms should be reported promptly.

Patients should also be aware that LYNKUET is designed for consistent, daily use. It’s not a medication you take only when symptoms flare – it works by gradually stabilizing the brain’s temperature‑regulation pathways.

How LYNKUET Compares to Other Hot Flash Treatments

Menopause management is not one‑size‑fits‑all. LYNKUET adds another tool to the toolkit, but it’s helpful to understand how it fits alongside other options.

Hormone Therapy

Hormone therapy remains the most effective treatment for hot flashes. However, it’s not appropriate for individuals with certain medical histories, such as breast cancer, blood clotting disorders, or cardiovascular risks. For these patients, LYNKUET offers a non‑hormonal alternative.

SSRIs and SNRIs

Some antidepressants – like paroxetine or venlafaxine – can reduce hot flashes, especially for people with mild to moderate symptoms. But they may cause mood changes, sexual side effects, or weight fluctuations. LYNKUET avoids these issues but requires liver monitoring.

Gabapentin

Gabapentin can be helpful for nighttime symptoms but often causes sedation or dizziness. LYNKUET may be better tolerated for daytime functioning.

Putting It All Together

Treatment	Hormonal?	Strengths	Limitations
LYNKUET	No	Effective; non‑hormonal; once daily	Liver monitoring; drowsiness; pregnancy risk
Hormone Therapy	Yes	Most effective overall	Not safe for many patients
SSRIs/SNRIs	No	Good for mild–moderate symptoms	Mood/sexual side effects
Gabapentin	No	Helpful for nighttime symptoms	Sedation, dizziness

LYNKUET represents an important step forward in menopause care. For the first time, patients have access to a non‑hormonal medication specifically designed to target the brain pathways that cause hot flashes. The clinical trial data is strong, the benefits are meaningful, and the once‑daily dosing is convenient.

That said, LYNKUET isn’t for everyone. Liver monitoring is essential, pregnancy must be avoided, and some people may experience drowsiness or other side effects. As with any medication, the best approach is a thoughtful conversation with a healthcare provider who understands your medical history, your symptoms, and your treatment goals.

For many people, LYNKUET may offer the relief they’ve been waiting for – without the need for hormone therapy.

References (3)

1. FDA Prescribing Information for LYNKUET (2025)
   https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf
2. Bayer U.S. – FDA Approval Announcement for LYNKUET
   https://www.bayer.com/en/us/news-stories/lynkuet
3. FDA Drug Trials Snapshot
   https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-lynkuet