A Guide to FDA-Approved Options
Vasomotor symptoms (VMS) – including hot flashes and night sweats – are among the most common symptoms of the menopause transition. They can significantly impact quality of life, sleep, mood, work, relationships, and long-term health. Women of color often experience more frequent and severe symptoms yet face greater barriers to high-quality, culturally responsive menopause care. With new prescription options emerging, understanding evidence-based treatments is essential.
Traditionally, hormone therapy (HT) has been the most effective treatment for menopausal hot flashes. However, HT is not ideal for everyone, including people with cardiovascular disease, a history of estrogen-sensitive cancers, or other contraindications. This makes increased access to non-hormonal treatments for hot flashes particularly important.
Recently, the U.S. Food and Drug Administration (FDA) approved two non-hormonal medications for moderate to severe VMS: Veozah® (fezolinetant) and Lynkuet® (elinzanetant).
We explain how they work, key benefits and risks, and why these therapies may be especially meaningful for women of color.
FDA-Approved Non-Hormonal VMS Medications
| Brand | Generic | Indication | Mechanism of Action | Key Evidence | Key Considerations |
| Veozah® | Fezolinetant (45 mg daily) | Moderate–severe VMS; FDA-approved May 2023 | NK3 receptor antagonist targeting neurokinin B signaling | Trials show reduced hot flash frequency & severity at weeks 4 & 12 vs. placebo | Not hormone-based; requires liver enzyme monitoring; FDA warning added for rare serious liver injury |
| Lynkuet® | Elinzanetant (60 mg daily) | Moderate–severe VMS; FDA-approved Oct 2025 | Dual NK1 + NK3 receptor blockade influencing sleep & thermoregulation | Trials show significant reduction in hot flashes by weeks 4 & 12; long-term data to 52 weeks | Non-hormonal; expected U.S. availability Nov 2025; evolving safety guidance; possible sleep benefits |
Veozah® (fezolinetant): How It Works & Who It’s For
Veozah was the first FDA-approved non-hormonal medication developed specifically for menopause-related hot flashes.
Key details
- Targets neurokinin B (NKB) activity in the hypothalamus (the body’s temperature “thermostat”)
- Clinical trials showed significant reductions in hot flash frequency and severity
- Useful for people who cannot or prefer not to take hormones
Safety:
- Requires periodic liver enzyme monitoring
- FDA added a warning for rare cases of serious liver injury
Considerations for women of color
Given higher rates of metabolic disease and medication burden, discussing potential liver or metabolic concerns with a clinician is especially important.
Lynkuet® (elinzanetant): What’s New
Lynkuet, FDA-approved in late 2025, is the first dual-pathway NK1/NK3 antagonist.
Key details
- Blocks NK1 and NK3 receptors, addressing hot flashes plus possible sleep disturbances
- In clinical trials, many participants saw:
- Hot flash improvement by week 4
- Approximately 50% reduction in symptoms by week 26
Added potential benefit
Early evidence suggests improved sleep and reduced night sweats.
Safety & access
- Long-term real-world safety data are still limited
- Liver function monitoring is recommended
- Expected U.S. availability begins late 2025; insurance coverage is evolving
Considerations for women of color
Could be especially helpful for people experiencing sleep disruption alongside VMS. However, coverage, cost, and provider familiarity may influence access.
Why These Options Matter for Women of Color
1) Increased non-hormonal choice: Women of color are more likely to have comorbidities (e.g., hypertension, obesity) that make hormone therapy less suitable. Non-hormonal FDA-approved medications expand safe, effective choices.
2) Targeted mechanism: These medications work at the neurokinin level, addressing the root cause of hot flashes rather than offering only symptomatic relief.
3) Sleep support: Night sweats and sleep issues are reported more frequently among women of color; Lynkuet’s preliminary sleep benefits are promising.
4) Personalized menopause care: More treatment options help counter the historical lack of culturally informed care in menopause.
5) Emphasis on safety monitoring: Clear clinical guidance – especially related to liver function – supports informed decision-making in populations often under-represented in trials.
Questions to Ask Your Healthcare Provider
- Are non-hormonal medications appropriate given my medical history?
- Should I consider Veozah vs. Lynkuet, based on my symptoms (daytime hot flashes vs. night sweats, sleep disruption)?
- What are likely insurance or out-of-pocket costs?
- How often should liver function tests be checked?
- How long should I expect to stay on therapy?
- What lifestyle approaches (e.g., exercise, stress management, nutrition, sleep care) can complement medication?
What We Still Need to Learn
Representation gaps: Clinical trials included limited Black, Hispanic/Latina, Asian, and Indigenous participants.
Long-term safety: More real-world data are needed on liver safety and use beyond 1–2 years.
Access & equity: Costs, provider awareness, and insurance may limit availability.
Symptom scope: These drugs treat hot flashes and night sweats, but not menopause-related insomnia, vaginal dryness, or bone loss on their own. Even though they are non-hormonal, these medications still require a prescription and medical supervision.
Moving Toward Equity in Menopause Care
For women of color, who disproportionately experience obstacles in menopause diagnosis and care, the approval of Veozah and Lynkuet represents real progress. They offer:
- Clinically proven hot flash relief
- Non-hormonal pathways
- Greater personalization and choice
However, achieving equitable benefit requires continued focus on access, cultural competency, and provider engagement. If you’re navigating bothersome VMS, talk with your clinician about whether these new treatments may support your symptom relief and quality of life.
NOVEMBER 2025