The short answer
Lynkuet (elinzanetant) is an FDA-approved, nonhormonal prescription capsule for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) due to menopause. It blocks both the neurokinin 1 and neurokinin 3 receptors. It is taken once daily at bedtime, can cause sleepiness, requires liver testing before starting and about three months after, and must not be used during pregnancy.
Key safety warnings: drowsiness, liver tests, and pregnancy
Lynkuet does not carry a boxed warning, but its label lists important precautions. It can cause somnolence and other central nervous system depressant effects, including next-day impairment. People who feel drowsy should not drive or do hazardous activities until the effect has resolved.
Liver bloodwork is required before starting; treatment should not begin if transaminases or total bilirubin are at least twice the upper limit of normal. Transaminases are rechecked about three months after starting. Stop the medicine and seek care for signs of liver injury such as yellow skin or eyes, dark urine, or right-sided abdominal pain.
It is contraindicated in pregnancy because it may cause pregnancy loss; pregnancy should be excluded first in anyone who could become pregnant. The label also adds a precaution about seizure risk in people with a seizure history.
Current label check
The medication-specific claims on this page were checked against these current product labels on 2026-10-03.
| Product label | Label date | Boxed warning on that label |
|---|---|---|
| Lynkuet (elinzanetant) capsules | 2026-06-16 | None |
Established evidence
What is Lynkuet?
Lynkuet is the brand name for elinzanetant, a prescription capsule made by Bayer. The FDA approved it in 2025 to treat moderate-to-severe vasomotor symptoms due to menopause. It is not a hormone, contains no estrogen or progesterone, and does not treat vaginal dryness, bone loss, or other menopause changes.
It is the second medication in the neurokinin-receptor antagonist family for hot flashes, after Veozah (fezolinetant), and the first to block two receptor types.
Established evidence
How elinzanetant works
When estrogen falls, a group of brain cells called KNDy neurons in the hypothalamus becomes overactive. Signaling through neurokinin B at the NK3 receptor, and substance P at the NK1 receptor, is thought to disturb the body's temperature set point, which produces the sudden heat, flushing, and sweating of a hot flash.
Elinzanetant blocks both receptors. The NK1 activity is one reason researchers have looked at sleep outcomes, and also a plausible reason sleepiness is among its most common side effects.
Established evidence
What the clinical trials showed
Approval was based on the OASIS 1 and OASIS 2 randomized, placebo-controlled trials in postmenopausal women with moderate-to-severe hot flashes, with OASIS 3 providing longer-term safety data. Elinzanetant reduced the frequency and severity of hot flashes more than placebo at weeks 4 and 12. Trials also measured sleep disturbance and menopause-related quality of life.
Placebo groups in hot-flash trials also improve substantially, so the meaningful figure is the difference between groups, not the total reduction. Averages cannot predict how one person will respond.
Established evidence
How it is taken
Lynkuet is an oral capsule taken once daily at bedtime, swallowed whole. Bedtime dosing reflects its sleepiness profile. A prescriber adjusts the plan when certain interacting medicines are used, so dosing decisions belong with the prescribing clinician and pharmacist, not a website.
Established evidence
Lynkuet side effects
The most frequently reported adverse reactions in trials (at least 5 percent) were headache, fatigue, dizziness, and somnolence. Most people who report these effects do so early in treatment, but anyone with persistent daytime impairment should talk with their prescriber.
Established evidence
Interactions and who should avoid it
- Pregnancy: contraindicated
- Strong CYP3A4 inhibitors and grapefruit juice: avoid use together
- Moderate CYP3A4 inhibitors: the label calls for a lower dose
- Strong and moderate CYP3A4 inducers: avoid use together
- Other sedating medicines or alcohol may add to drowsiness
- Not recommended in end-stage kidney disease or moderate-to-severe liver impairment
Lynkuet vs Veozah: documented differences
Both are nonhormonal, FDA-approved treatments for moderate-to-severe menopause hot flashes. They have not been compared head to head in a published randomized trial, so no one can say which works better. Their labels differ in mechanism, dosing time, and safety monitoring.
| Feature | Lynkuet (elinzanetant) | Veozah (fezolinetant) |
|---|---|---|
| Receptor target | NK1 and NK3 | NK3 only |
| FDA approval | 2025 | 2023 |
| When taken | Once daily at bedtime | Once daily, any consistent time |
| Boxed warning | None | Hepatotoxicity |
| Liver testing | Before starting and about 3 months after | Before starting, monthly for months 1 to 3, then months 6 and 9 |
| Notable precautions | Sleepiness, pregnancy loss, seizure history | Serious liver injury, CYP1A2 inhibitors, cirrhosis |
How it fits alongside hormone therapy
The Menopause Society continues to describe hormone therapy as the most effective treatment for hot flashes for appropriate candidates. Neurokinin antagonists give an evidence-based option for people who cannot, or prefer not to, use hormones, such as some people with a history of hormone-sensitive cancer, clotting history, or personal preference. They do not protect bone or treat genitourinary symptoms the way estrogen can.
Questions to ask a healthcare professional
- Are my hot flashes moderate to severe, and what else could be causing them?
- How do Lynkuet, Veozah, hormone therapy, and other options compare for my history?
- Do any of my current medicines interact with elinzanetant?
- How will drowsiness affect my work or driving?
- When will my liver tests be done, and what results would change the plan?
Questions, answered
What people ask about Lynkuet
Is Lynkuet hormonal?+
No. Elinzanetant blocks neurokinin receptors in the brain and contains no estrogen, progesterone, or other hormone.
Is Lynkuet FDA approved?+
Yes. The FDA approved Lynkuet in 2025 for moderate-to-severe vasomotor symptoms due to menopause.
Does Lynkuet require liver tests?+
Yes. The label calls for liver bloodwork before starting and a transaminase check about three months after starting, plus stopping treatment if signs of liver injury appear.
Does Lynkuet make you sleepy?+
It can. Somnolence and fatigue are among the most common side effects, which is why it is taken at bedtime and why people who feel impaired should not drive.
Is Lynkuet better than Veozah?+
There is no head-to-head trial showing either is superior. They differ in mechanism, monitoring, and side-effect profile, which a clinician weighs against your history.
Does Kindr Health offer Lynkuet?+
This page is educational and does not state or imply that Lynkuet is available through Kindr Health.
Kindr Health does not claim to offer Lynkuet on this page. Availability and prescribing are not implied.
A broader care pathway
Explore menopause care
Learn how Kindr Health care pathways work. An educational page is not a statement that this medication is available or appropriate for you.
SOURCES & REFERENCES
Every clinical claim on this page is sourced.
- LYNKUET (elinzanetant) capsules prescribing information (2025) — U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf
- LYNKUET prescribing information (current revision) (2026) — Bayer HealthCare. labeling.bayerhealthcare.com/html/products/pi/Lynkuet_PI.pdf
- The 2023 nonhormone therapy position statement of The North American Menopause Society (2023) — The Menopause Society (Menopause journal). menopause.org/wp-content/uploads/professional/2023-nonhormone-therapy-position-statement.pdf
This resource is educational and does not replace individualized medical advice. Do not start, stop, or change a prescription without guidance from a licensed healthcare professional.