Veozah (Fezolinetant) for Hot Flashes: What You Need to Know

Hot flashes have been around as long as menopause has. The treatments have mostly stayed the same for decades: hormone therapy, antidepressants prescribed off-label, or a long list of supplements with modest and inconsistent results. That changed in 2023 when the FDA approved a genuinely new type of treatment.

Veozah is the brand name. Fezolinetant is the generic name. It is the first drug in its class to be approved specifically for moderate to severe hot flashes. It does not contain estrogen. It does not belong to the antidepressant family. It works on a completely different mechanism that researchers have been investigating for years. For women who cannot or do not want to use hormone therapy, it represents a meaningful new option.

How hot flashes actually start in the brain

Understanding why Veozah works requires a brief look at what triggers hot flashes in the first place.

The hypothalamus is a small region of the brain that acts as your body's thermostat. It regulates core body temperature within a narrow range. Estrogen helps maintain that thermostat's sensitivity. When estrogen levels decline during perimenopause and menopause, the thermostat becomes unstable. The "thermoneutral zone," the range of temperatures your body tolerates without triggering a heat-dissipation response, narrows significantly. Small changes in body temperature that your brain would normally ignore instead trigger a cascade: blood vessels near the skin dilate, you feel intensely hot, you sweat, and your heart rate rises. That is a hot flash.

A specific population of neurons in the hypothalamus, called KNDy neurons, sits at the center of this process. These neurons release a chemical messenger called neurokinin B (NKB). When estrogen declines, KNDy neurons become overactive and release excess NKB. That excess activity sends faulty heat-dissipation signals through the thermostat and triggers hot flashes.

Fezolinetant blocks the receptor that NKB binds to. It dials down the overactive KNDy neuron signaling at its source. Less NKB activity means fewer misfiring thermostat signals. Fewer misfiring signals means fewer hot flashes.

What the clinical trials showed

Veozah was approved based on two large phase 3 clinical trials called SKYLIGHT 1 and SKYLIGHT 2. Both trials enrolled women with moderate to severe hot flashes (at least seven per day or at least 50 per week) and ran for 52 weeks.

The results were clinically meaningful. Women taking 45 mg of fezolinetant daily experienced significant reductions in both hot flash frequency and severity beginning in week one. By week four, the reduction compared to placebo was statistically significant and continued to improve through the first 12 weeks. At 12 weeks, women on fezolinetant had roughly a 60 percent reduction in hot flash frequency compared to about a 45 percent reduction in the placebo group. Hot flash severity decreased as well.

The 52-week data showed the benefits were durable. They were not a short-term effect that faded over time. Women who completed the full year of treatment continued to show improved hot flash control.

Side effects reported in the trials included headache, abdominal pain, diarrhea, insomnia, and hot flush. Most were mild to moderate. The main safety signal that requires monitoring is liver enzyme elevation. About 2 to 3 percent of women in the trials had elevated liver enzymes, most of which were mild, transient, and resolved without stopping the medication. Liver function tests are required before starting fezolinetant and periodically during treatment.

Who Veozah is designed for

Veozah was developed specifically as a non-hormonal option. It is most relevant for women who cannot use estrogen-containing therapy or prefer not to.

This includes women with a history of estrogen-sensitive cancers, particularly breast cancer, where systemic estrogen therapy is often contraindicated. It includes women with a personal or family history of blood clots, stroke, or cardiovascular conditions that make hormone therapy higher-risk. It includes women who have tried hormone therapy and found it was not tolerable for them. And it includes women who simply prefer a non-hormonal approach and want an option beyond antidepressants.

Veozah is approved for moderate to severe vasomotor symptoms. If hot flashes are mild or infrequent, it is generally not the right starting point. For women whose hot flashes are disrupting sleep, work, and daily functioning, and who are not candidates for or interested in hormone therapy, it is a legitimate first-line option to discuss with your provider.

It is not approved for use in women with severe hepatic (liver) impairment or in those taking strong CYP1A2 inhibitors, a class of medications that would raise fezolinetant levels significantly. Your provider will review your medications and liver function before prescribing.

How Veozah compares to other options

Before Veozah, women seeking non-hormonal hot flash treatment had a few categories to choose from, each with limitations.

SSRIs and SNRIs (paroxetine, venlafaxine, desvenlafaxine) reduce hot flash frequency by about 50 to 60 percent in trials. They are widely used off-label and have decades of safety data. They also come with antidepressant-class side effects including sexual side effects, weight changes, and discontinuation syndromes. Paroxetine (Brisdelle) is the only SSRI formally approved for hot flashes, at a lower dose than used for depression.

Gabapentin reduces hot flash frequency and is useful particularly for nighttime symptoms. It causes sedation and dizziness, which limits daytime tolerability for many women.

Oxybutynin, an overactive bladder medication, has shown moderate benefit for hot flashes in some studies and is sometimes prescribed off-label.

Fezolinetant compares favorably on efficacy to these non-hormonal options and has a different side effect profile. It does not carry the antidepressant-class effects or the sedation of gabapentin. The liver monitoring requirement is a genuine consideration, but for women who do not do well with the other options, Veozah offers a distinct mechanism and a different set of tradeoffs.

For women who can use hormone therapy, that remains the most effective treatment for hot flashes and has the additional benefits of addressing other perimenopause symptoms like sleep disruption and mood. Veozah does not replace HRT where HRT is appropriate and desired. It fills a gap for women who need or want a non-hormonal path.

Cost and insurance coverage

Cost is a significant practical issue with Veozah. The list price is roughly $550 to $600 per month without insurance coverage. That is a substantial barrier.

Insurance coverage has been inconsistent since the drug launched. Some plans cover it, particularly when hormone therapy is contraindicated and documented. Others classify it as non-preferred or require prior authorization with documentation that other options have been tried first.

Astellas, the manufacturer, has offered a patient assistance program and a copay card for commercially insured patients. These programs change over time, so it is worth asking your provider's office to run a prior authorization and checking the manufacturer's website directly for current savings offers.

For women whose insurance does not cover it and who do not qualify for patient assistance, the cost may make it impractical. This is a real limitation and one worth discussing honestly with your provider when weighing options.

What to expect when starting Veozah

The dose is 45 mg taken once daily by mouth, at the same time each day, with or without food.

Many women notice some improvement in hot flash frequency within the first week. Meaningful reduction typically becomes clear by weeks two to four. The full benefit develops over the first 12 weeks. Unlike some medications where you might see the peak effect quickly and then taper off, Veozah's clinical data shows continued improvement through three months.

Before starting, your provider will check liver function tests (ALT and AST). These are typically rechecked at three months, six months, and nine months during the first year. If you develop symptoms that could suggest liver problems, including jaundice, unusual fatigue, right-side abdominal pain, or dark urine, contact your provider promptly.

If you decide to stop taking Veozah, there is no known discontinuation syndrome the way there is with antidepressants. Hot flashes are likely to return. You and your provider can discuss whether to transition to another treatment or re-evaluate based on where you are in your menopause transition at that point.

Veozah does not interact with most common medications, but it is processed by the CYP1A2 liver enzyme pathway. Your provider will review your full medication list. Notably, it can be used alongside vaginal estrogen, which does not count as systemic hormone therapy and does not conflict with the non-hormonal approach.

Veozah is not the right choice for everyone, and it is not inexpensive. But for women who need effective, non-hormonal hot flash treatment and have not found adequate relief from other options, it represents a genuinely new category of medicine based on a better understanding of what actually causes hot flashes. That matters.

If your hot flashes are significantly affecting your sleep or daily life and hormone therapy is not an option for you, Veozah is worth a direct conversation with your provider.

This content is for informational purposes only and does not replace medical advice. Always consult your healthcare provider about your specific situation.