ACOG’s new 2026 menopause guideline: what changed for hormone therapy and the newer non-hormonal drugs

On October 15, 2026, the American College of Obstetricians and Gynecologists published Clinical Practice Guideline No. 13, “Management of Menopause-Related Vasomotor, Sleep, and Mood Symptoms,” in its journal Obstetrics & Gynecology.^[1]It replaces Practice Bulletin No. 141, which had been ACOG’s standing guidance on this topic since January 2014.^[1] A companion guideline on genitourinary syndrome of menopause is planned for 2027.^[5]

An update was overdue for two reasons. A new drug class, neurokinin-3 (NK3) receptor antagonists, reached the market after the 2014 bulletin was written: fezolinetant in 2023 and elinzanetant in 2025. And in February 2026 the FDA removed cardiovascular, breast cancer, and dementia boxed warnings from menopausal hormone therapy labels, which we covered in detail in our companion article on the FDA’s 2026 hormone therapy label changes. This guideline is ACOG’s own clinical synthesis of where the evidence and the regulatory picture now stand, not a new trial or a new drug approval in itself.

ACOG “strongly recommends” systemic menopausal hormone therapy for vasomotor symptoms and vasomotor-related sleep disturbance in patients without contraindications to hormone use, built on evidence it grades as moderate quality.^[1]That distinction matters: a strong recommendation reflects the guideline panel’s confidence that benefits outweigh harms for the right patient, which is a judgment call, not a claim that the underlying evidence itself reaches the highest tier.

Patients with a uterus are recommended estrogen plus a progestogen; estrogen alone is used when endometrial protection is not needed. Conjugated estrogen with bazedoxifene is offered as a conditional alternative for patients who want to avoid progestogen-related bleeding or breast tenderness.^[1] ACOG recommends starting therapy before age 60 or within 10 years of natural menopause onset, a strong recommendation built on lower-quality evidence than the core treatment recommendation itself; starting later calls for an individualized discussion given higher baseline risks of blood clots, stroke, and coronary disease.^[1]

On mood, the guideline is notably restrained: ACOG says the evidence is insufficient to recommend for or against hormone therapy specifically for menopause-related depressive symptoms, and patients meeting criteria for major depressive disorder should be managed under depression-specific guidelines instead.^[1] For the fuller breakdown of how risk and benefit shift by regimen, route, and individual history, see our companion article, Menopause and hormone therapy: what the evidence says.

For patients who do not want or cannot use hormone therapy, ACOG strongly recommends SSRIs or SNRIs, citing moderate-to-high-quality evidence.^[1] Low-dose paroxetine (7.5 mg daily) is the only antidepressant with specific FDA approval for vasomotor symptoms, though citalopram, escitalopram, venlafaxine, and desvenlafaxine also reduced symptoms in trials ACOG cites; fluoxetine and paroxetine are generally avoided in patients taking tamoxifen because both inhibit the enzyme that activates it.^[1]

The newer piece is NK3 receptor antagonists, which also carry a strong recommendation.^[1] Elinzanetant, a dual NK1/NK3 antagonist sold as Lynkuet, was tested in the OASIS 1 and OASIS 2 phase 3 randomized trials, published in JAMAin 2024. Across both trials, elinzanetant reduced moderate-to-severe hot flash frequency by a least squares mean of roughly 3 fewer episodes per 24 hours versus placebo at week 12 (OASIS 1: −3.2, 95% CI −4.8 to −1.6; OASIS 2: −3.2, 95% CI −4.6 to −1.9), with similarly significant reductions in severity (both P < .001).^[2] Fezolinetant, an NK3-selective antagonist sold as Veozah, was tested in the SKYLIGHT 1 phase 3 trial, published in The Lancet in 2023, which found statistically significant reductions in both frequency and severity of hot flashes at weeks 4 and 12 versus placebo, sustained through the trial’s active treatment extension.^[3]

Both drugs carry liver-related monitoring requirements that are worth knowing before starting either one. The FDA added a boxed warning to fezolinetant’s label in December 2024 for a rare but serious risk of liver injury, and calls for hepatic lab testing before treatment, monthly for the first three months, and again at months 6 and 9.^[4]Elinzanetant’s label calls for a lighter schedule, liver testing at baseline and at 3 months, reflecting a different safety profile in its own trials.^[1] Gabapentin is a conditional suggestion when these recommended non-hormonal options are ineffective or poorly tolerated, with bedtime dosing advised because of its sedating effect; clonidine is specifically not recommended as a primary treatment.^[1]

The guideline is just as direct about what does not work as it is about what does. ACOG states that evidence does not support the efficacy or safety of phytoestrogens, such as soy isoflavones, or herbal supplements for vasomotor, sleep, or mood symptoms, and notes that these products are not regulated by the FDA for safety, efficacy, or purity.^[1] It makes the same statement about progestogen monotherapy, DHEA, and testosterone for these specific symptoms.^[1] Oxybutynin, sometimes used off-label for hot flashes, has adverse effects, including cognitive decline, that limit its use in women older than 65.^[1]

ACOG conditionally suggests cognitive behavioral therapy (CBT) for vasomotor symptoms, sleep disturbance, and mood, citing low-to-moderate-quality evidence: a pooled analysis of 14 randomized trials (1,618 participants) found a small-to-moderate improvement in hot flash frequency (Hedges g 0.36, 95% CI 0.21 to 0.51).^[1]

Acupuncture also receives a conditional suggestion, but on weaker footing: ACOG cites low-quality evidence, with mixed results against sham acupuncture in trials conducted mostly in China.^[1] Mindfulness-based interventions, exercise, and clinical hypnosis round out the conditional suggestions; the guideline frames all of these non-pharmacologic options as something to use alongside medication for most patients, not as standalone alternatives to the strongly recommended treatments above.^[1]

None of this guideline changes the safety signals that already warrant urgent attention on hormone therapy or the newer non-hormonal drugs.

ACOG’s Clinical Practice Guideline No. 13 is a genuine, overdue update, not a new finding. It strongly backs hormone therapy for the right candidates on evidence it itself calls moderate quality, strongly backs SSRIs, SNRIs, and the newer NK3 antagonists as non-hormonal alternatives with real liver-monitoring tradeoffs, offers CBT and a short list of other non-drug options as conditional add-ons, and explicitly tells patients and clinicians that phytoestrogens, herbal supplements, DHEA, and testosterone do not have the evidence behind them for these symptoms. See how we grade the strength of evidence across topics in our editorial and evidence standards, and browse the rest of our Hormone & Vitality coverage as it grows.

None of this replaces an individual conversation with a prescribing clinician who knows your symptoms, medical history, and personal risk factors. It reflects what ACOG, the cited trials, and the FDA’s own safety communications actually say.