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Menopause and Perimenopause: What the Evidence Says About Hormones, New Non-Hormonal Drugs and Supplements

Hormone therapy is still the most effective treatment for hot flashes, the FDA removed most of its boxed warning in 2026, two non-hormonal pills are now approved, and most menopause supplements have weak or null trials.

By Kymata Health editorial teamLast verified October 10, 2026

Medical review pending. Written by our editorial team from the studies and documents cited below; a credentialed clinician has not reviewed it yet. Educational only, not medical advice.

Key takeaways

  • In the Women's Health Initiative trials, hormone therapy did not change 18-year all-cause mortality (HR 0.99 across both trials), and women who started at 50 to 59 fared better than women who started at 70 to 79 [1].
  • On February 12, 2026 the FDA approved new labels for six menopausal hormone products that drop cardiovascular disease, breast cancer and probable dementia from the boxed warning; the endometrial-cancer box stays on systemic estrogen-alone products [2][3].
  • Menopause specialists call hormone therapy the most effective treatment for hot flashes, with a favorable balance for women under 60 or within 10 years of menopause who have no contraindications [4].
  • Two non-hormonal prescription pills are approved for moderate to severe hot flashes: fezolinetant (Veozah, which carries a boxed warning for liver injury) and elinzanetant (Lynkuet, approved 2025) [5][6].
  • A Cochrane review of 16 trials found black cohosh no better than placebo for hot flash frequency; the 2023 nonhormone position statement does not recommend supplements or herbal remedies for hot flashes [7][8].

Guides in this hub

  1. The FDA Took the Black Box Off Menopause Hormones. Here Is What the Trials Actually ShowedThe 2002 Women's Health Initiative scared a generation off hormone therapy. Twenty years of follow-up, a trial on timing and a 2026 label change tell a more careful story, including the risks that remain.
  2. Can't or Won't Take Hormones? The Non-Hormonal Hot Flash Treatments That Beat PlaceboTwo new brain-targeted pills, an older list of repurposed drugs, and behavioral therapy all have trial data for hot flashes. Here is how they compare, and the side effects to watch.
  3. Menopause Supplements vs Placebo: Black Cohosh, Soy and the Blends Sold on InstagramBlack cohosh did no better than placebo for hot flashes in pooled trials. Soy isoflavones did modestly better, yet experts still do not recommend them. Brand-name blends have no published trials we could find.

Where to start

Perimenopause is the years of irregular cycles before the final period; menopause is confirmed after 12 months without one. Hot flashes and night sweats (vasomotor symptoms), poor sleep and vaginal dryness are the symptoms with the best trial data behind their treatments [4].

For bothersome hot flashes, the 2022 hormone therapy position statement says hormone therapy remains the most effective treatment and that its risks depend on type, dose, route, timing and whether a progestogen is used [4]. If hormones are not an option, the 2023 nonhormone statement recommends cognitive behavioral therapy, clinical hypnosis, SSRIs or SNRIs, gabapentin and fezolinetant, and does not recommend supplements, herbal remedies or soy extracts [8].

Why the age you start matters

The 2002 WHI estrogen-plus-progestin trial stopped early when invasive breast cancer crossed its safety boundary, with about 8 more breast cancers, 7 more coronary events and 8 more strokes per 10,000 women per year, and fewer hip fractures and colorectal cancers [9]. Its participants averaged 63 years old, older than most women who start hormones for symptoms [1].

In the ELITE trial, oral estradiol slowed artery-wall thickening when started within 6 years of menopause but not when started 10 or more years after [10]. That pattern, plus the WHI age analyses, is why current labels and guidance focus on starting before 60 or within 10 years of menopause [3][4].

Getting a prescription: what to compare

Online menopause services differ in three ways that change what you pay and what you get: whether the medication is FDA-approved or compounded (compounded hormones are not FDA-approved), whether they bill your insurance, and whether medication is included or billed by your own pharmacy. Our side-by-side HRT comparison and cost breakdown show those details with published prices.

Partners we link to

Paid links: we earn a commission if you buy through these, at no extra cost to you. It never changes what the evidence sections say. Affiliate disclosure.

  • WinonaPaid linkOnline menopause care with FDA-approved estradiol tablets (from $54/mo published, checked Oct 8, 2026) plus compounded creams that are not FDA-approved. Ages 35 to 59; runs its own 503A pharmacies.See Winona's menopause plans
  • GalaPaid linkOnline hormone care for women from a published "from $69/mo" price (checked Oct 8, 2026); Gala says it prescribes FDA-approved bioidentical forms and ships free.See Gala's hormone plans

Regulatory and legal notes

  • Boxed warning: the FDA initiated removal of the cardiovascular, breast cancer and probable dementia language from hormone therapy boxed warnings on November 10, 2025 and approved the first six revised labels on February 12, 2026; cardiovascular and breast cancer warnings stay in the labels' warnings section [2][3].
  • Hers: the FDA sent Hims & Hers Health (dba Hers) warning letter 716825 on September 9, 2025 over claims about its compounded semaglutide, not its menopause care; the letter says compounded drugs are not FDA-approved [11].
  • Fezolinetant (Veozah) gained a boxed warning for rare but serious liver injury in December 2024; liver blood tests are required before and during treatment [5].
  • Supplements sold for menopause are not reviewed by the FDA for effectiveness before sale, and none of the brand-name blends named on this page has a published randomized trial that we could find in PubMed (searched October 10, 2026).

Other names you will see

Listed for completeness. We have no paid relationship with these brands and do not link to them.

  • Midi Health: Insurance-billed menopause visits with clinicians trained in menopause care; medication is billed by your own pharmacy.
  • Evernow: Menopause care billed to insurance plus a membership; medication cost is not published.
  • Hers: Prescription menopause care from Hims & Hers; see the FDA warning letter note above (it concerns compounded semaglutide claims).
  • Womaness: Over-the-counter menopause supplements and skin care; dietary supplements, not drugs.
  • Happy Mammoth: Sells multi-ingredient "hormone" supplement blends; caveat: we found no published randomized trial of its blends, and single herbs such as black cohosh have not beaten placebo in pooled trials [7].

References

  1. [1]Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA, 2017. PMID 28898378
  2. [2]FDA Approves Labeling Changes to Menopausal Hormone Therapy Products. U.S. Food and Drug Administration, 2026.
  3. [3]FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies. U.S. Food and Drug Administration, 2025.
  4. [4]The 2022 hormone therapy position statement of The North American Menopause Society. Menopause, 2022. PMID 35797481
  5. [5]FDA adds Boxed Warning for rare but serious liver injury with Veozah (fezolinetant). U.S. Food and Drug Administration, Drug Safety Communication, 2024.
  6. [6]LYNKUET (elinzanetant) capsules: prescribing information, initial U.S. approval 2025. U.S. Food and Drug Administration (Drugs@FDA), 2025.
  7. [7]Black cohosh (Cimicifuga spp.) for menopausal symptoms. Cochrane Database Syst Rev, 2012. PMID 22972105
  8. [8]The 2023 nonhormone therapy position statement of The North American Menopause Society. Menopause, 2023. PMID 37252752
  9. [9]Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA, 2002. PMID 12117397
  10. [10]Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol (ELITE). N Engl J Med, 2016. PMID 27028912
  11. [11]Warning letter to Hims & Hers Health, Inc. dba Hers, MARCS-CMS 716825. U.S. Food and Drug Administration, 2025.

Dietary supplements are not intended to diagnose, treat, cure or prevent any disease, and these statements have not been evaluated by the FDA. Prescription options need a licensed clinician. Talk to your clinician or pharmacist before starting anything new, especially if you take prescription medicines, are pregnant or breastfeeding.

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