ACOG guideline expands menopause VMS, sleep, and mood recommendations

The American College of Obstetricians and Gynecologists (ACOG) has issued its most comprehensive guidance to date on managing menopause, with a new clinical practice guideline covering menopausal hormone therapy (MHT), nonhormonal medications, and nonpharmacologic treatment of vasomotor symptoms (VMS), sleep disturbance, and mood symptoms. Clinical Practice Guideline No. 13, published online October 15, 2026, in Obstetrics & Gynecology, replaces Practice Bulletin No. 141 from January 2014.^1,2

According to the guidance, 50% to 92% of women in menopause report VMS, 16% to 66% of women in the United States report menopause-related sleep disruption, and more than one-third of perimenopausal and postmenopausal women worldwide report depressive symptoms. ACOG is also developing companion guidance on genitourinary syndrome of menopause, expected in 2027.¹

How ACOG graded its menopause recommendations

ACOG used a modified GRADE framework to build its recommendations from systematic reviews, meta-analyses, and randomized controlled trials (RCTs), and each one carries 2 ratings:

• A strong recommendation, worded “ACOG recommends,” means benefits clearly outweigh harms and most patients should receive the intervention.²
• A conditional recommendation, worded “ACOG suggests,” means the balance depends on patient characteristics and preferences and calls for shared decision-making.

Evidence quality ranges from high (RCTs and meta-analyses without serious flaws, unlikely to change with further research) to moderate (RCTs with some limitations), low (RCTs with serious flaws or limited observational data), and very low (unsystematic clinical observations). Ungraded good practice points reflect expert opinion where evidence is extremely limited or absent.

Below, see recommendations and associated recommended strength along with quality of evidence, quoted from the clinical practice update published in Obstetrics & Gynecology.²

Hormone therapy recommendations for VMS and sleep

• “ACOG recommends the use of systemic MHT with estrogen and a progestogen (in individuals with a uterus) or estrogen alone (if endometrial protection is not needed) for the management of VMS in individuals without contraindications to hormone use.” (Strong recommendation, moderate-quality evidence)
• “ACOG recommends the use of systemic MHT with estrogen and a progestogen (in individuals with a uterus) or estrogen alone (if endometrial protection is not needed) for the management of vasomotor-related sleep disturbance in individuals without contraindications to hormone use.” (Strong recommendation, moderate-quality evidence)

In a meta-analysis cited by the guideline, estrogen therapy with or without a progestogen reduced VMS frequency (relative risk [RR], 0.43; 95% CI, 0.33-0.57) and severity (RR, 0.29; 95% CI, 0.17-0.50) vs placebo or no treatment. A network meta-analysis of 32 RCTs ranked transdermal estradiol plus a progestogen as the most effective option for reducing VMS frequency.

For sleep, a meta-analysis of 15 RCTs (N = 27,715) linked MHT with improved self-reported sleep quality (standardized mean difference [SMD], −0.13; 95% CI, −0.18 to −0.08), but not with objective polysomnography measures. Transdermal and 17β-estradiol regimens showed the largest effects.

• “ACOG suggests the combination of conjugated estrogen and bazedoxifene as an alternative to estrogen–progestogen therapy for the management of VMS in individuals without contraindications to hormone use.” (Conditional recommendation, low-to-moderate–quality evidence)
• “ACOG suggests the combination of conjugated estrogen and bazedoxifene as an alternative to estrogen–progestogen therapy for the management of vasomotor-related sleep disturbance in individuals without contraindications to hormone use.” (Conditional recommendation, low-to-moderate–quality evidence)

In this tissue-selective estrogen complex, bazedoxifene replaces the progestogen to limit endometrial and breast stimulation, which the guideline notes may suit patients who want to avoid progestogen-related bleeding and breast tenderness. In a post hoc SMART-2 analysis, participants reached a 50% reduction in hot flush frequency within 8 to 10 days. Pooled safety data showed no increase in breast cancer, endometrial cancer, venous thromboembolism (VTE), stroke, or coronary heart disease (CHD) vs placebo, although follow-up extends only to 2 years.

Regarding the use of the phrase “hot flush,” ACOG noted in the guidance that, “Although the sudden sensation of extreme heat in the upper body, particularly the face, neck, and chest, is sometimes referred to as a ‘hot flash,’ the term “hot flush” is preferred because it conveys that the sensation is not necessarily momentary and typically lasts 1-5 minutes.”

When should MHT be started?

• “When MHT is selected for the management of VMS and vasomotor-related sleep disturbance, ACOG recommends initiation of therapy before age 60 years or within 10 years of the start of natural menopause in individuals without contraindications to hormone use.” (Strong recommendation, low-to-moderate–quality evidence)
• “The decision to initiate MHT for the management of VMS or vasomotor-associated sleep disturbance should be based on a shared decision-making discussion about the patient’s symptoms and the benefits and risks of therapy, with consideration of each patient’s age; medical history; baseline risks of cardiovascular disease, breast cancer, and venous thromboembolism (VTE); and individualized treatment goals and priorities.” (Good practice point)

The timing recommendation draws on a Cochrane review of 19 trials (N = 40,410). Participants who began MHT before age 60 years or within 10 years of menopause onset had a lower risk of CHD (RR, 0.52; 95% CI, 0.29-0.96), similar stroke risk, and higher VTE risk (RR, 1.74; 95% CI, 1.11-2.73). Initiation more than 10 years after onset carried greater VTE risk (RR, 1.96; 95% CI, 1.37-2.80) and elevated stroke risk (RR, 1.21; 95% CI, 1.06-1.38). The guideline also notes that nearly 67% of Women’s Health Initiative participants were aged 60 years or older, limiting generalizability to younger patients, and that in 2025 the FDA removed boxed warnings for cardiovascular disease, breast cancer, and probable dementia from MHT labeling.²

• Hormone therapy is a really important tool we have to help with menopause symptom management. Unfortunately, misconceptions about the risks of hormone therapy have affected some clinicians’ willingness to prescribe it and some patients’ interest in using it. This new guidance importantly includes a comprehensive review of the evidence on menopausal hormone therapy to guide individualized patient counseling and shared-decision-making conversations about treatment options,” said Bruce Pier, MD, FACOG, coauthor of the guidance.¹

The guideline adds 3 good practice points on monitoring, discontinuation, and mood:

• “Persistent or unscheduled bleeding after initiation of MHT warrants evaluation for endometrial intraepithelial neoplasia/atypical endometrial hyperplasia and endometrial cancer.” (Good practice point)
• “The decision about when and how to discontinue MHT should be individualized based on ongoing risk factor assessment and a shared decision-making discussion of the benefits and risks.” (Good practice point)
• “The available evidence is insufficient to recommend for or against the use of estrogen–progestogen or estrogen-only MHT for the treatment of menopause-related depressive symptoms. Perimenopausal and postmenopausal patients who meet diagnostic criteria for major depressive disorder (MDD) or for whom depression is the predominant symptom should be treated according to depression-management guidelines.” (Good practice point)

Nonhormonal drug options, including neurokinin receptor antagonists

• “ACOG recommends selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) for the management of menopausal symptoms (vasomotor and depression) in patients who do not desire or have a contraindication to hormone therapy.” (Strong recommendation, moderate-to-high–quality evidence)

Paroxetine 7.5 mg/d is the only antidepressant FDA-approved for VMS, but other SSRIs and SNRIs have reduced VMS frequency and severity vs placebo. In a meta-analysis of 7 RCTs (N = 1676), SSRIs and SNRIs moderately improved depression severity (Hedges g, 0.44; 95% CI, 0.32-0.57). The guideline advises generally avoiding fluoxetine and paroxetine in patients taking tamoxifen.

• “ACOG recommends neurokinin receptor antagonists for the management of VMS and vasomotor-related sleep disturbance in patients who do not desire or have a contraindication to hormone therapy.” (Strong recommendation, moderate-to-high–quality evidence)

FDA-approved fezolinetant and elinzanetant

Two agents are FDA-approved: fezolinetant (Veozah; Astellas Pharma US), a neurokinin-3 receptor antagonist, and elinzanetant (Lynkuet; Bayer HealthCare Pharmaceuticals), a dual neurokinin-1 and neurokinin-3 receptor antagonist.

In pooled SKYLIGHT 1 and 2 data, fezolinetant benefits appeared as early as day 1 and were maintained for 52 weeks. Its label carries a boxed warning requiring liver function testing before and during the first 9 months of use.

In OASIS 1 (N = 396), 12 weeks of elinzanetant reduced VMS frequency (least squares mean difference, −3.2; 95% CI, −4.8 to −1.6) and sleep disturbance (least squares mean difference, −5.6; 95% CI, −7.2 to −4.0) vs placebo; its label recommends liver testing at baseline and 3 months.²

“Hormone therapy can be a great option—and in many cases, the best option—but may not be appropriate or helpful for every person experiencing menopausal symptoms,” said Robert P. Kauffman, MD, MSCP, FACOG, coauthor of the guidance.¹

“It was important when creating this guidance to address a variety of treatment options—whether hormonal or nonhormonal, or even nonpharmacologic—to ensure that clinicians have the information they need to help patients manage vasomotor, sleep, and mood symptoms. We have evaluated the data behind a variety of treatment options to ultimately help more women get the care that’s right for them as individuals,” said Kauffman.

• “ACOG suggests gabapentin for the management of VMS when other recommended nonhormonal pharmacologic interventions are ineffective or poorly tolerated by patients who do not desire or have a contraindication to hormone therapy.” (Conditional recommendation, moderate-quality evidence)

Gabapentin reduced VMS frequency in a meta-analysis of 7 RCTs (mean difference, −2.77; 95% CI, −4.29 to −1.24), but pooled severity results did not reach statistical significance. Bedtime dosing is advised because of sedation. The guideline does not recommend clonidine as a primary treatment, and notes that oxybutynin’s adverse effects, including cognitive decline in women older than 65 years, limit its use.²

Nonpharmacologic interventions for VMS, sleep, and mood

• “ACOG suggests cognitive behavioral therapy (CBT) for the management of VMS and menopause-related sleep disturbance and mood symptoms.” (Conditional recommendation, low-to-moderate–quality evidence)
• “ACOG suggests mindfulness-based interventions (MBIs) to improve menopause-related sleep disturbance and mood symptoms.” (Conditional recommendation, low-to-moderate–quality evidence)
• “ACOG suggests physical exercise to improve menopause-related sleep disturbance and mood symptoms.” (Conditional recommendation, low-to-moderate–quality evidence)
• “ACOG suggests clinical hypnosis to reduce VMS and improve menopause-related sleep disturbance and anxiety symptoms.” (Conditional recommendation, low-quality evidence)
• “ACOG suggests acupuncture to reduce VMS and improve menopause-related sleep disturbance and mood symptoms.” (Conditional recommendation, low-quality evidence)

These approaches can be used alone but are generally recommended alongside hormonal or nonhormonal medications. In a meta-analysis of 14 RCTs (N = 1618), CBT produced small-to-moderate improvements in hot flush frequency (Hedges g, 0.36; 95% CI, 0.21-0.51). MBIs reduced sleep disturbance in a meta-analysis of 13 RCTs (SMD, −0.91; 95% CI, −1.28 to −0.54), and exercise reduced sleep disruption scores across 25 RCTs (SMD, −1.60; 95% CI, −2.03 to −1.18). Confidence in the clinical hypnosis data is limited by the small number of studies and methodologic concerns, while acupuncture trials have shown mixed results vs sham and were conducted mostly in China. Given their low risk, the guideline considers both reasonable as part of a multimodal approach.

The guideline also states that evidence does not support the efficacy or safety of phytoestrogens, such as soy isoflavones, or herbal supplements, which are not regulated by the FDA or tested for safety, efficacy, or purity.²

Addressing inequities in menopause care

“Racial, cultural, and socioeconomic factors affect how individuals experience menopause and what level of care they receive. Physicians need to be aware of these disparities and inequities so that we can understand the barriers facing our patients and help to close these gaps in care,” said Catherine D. Cansino, MD, MPH, FACOG, author of the guidance.

ACOG also called for earlier, more comprehensive patient education so that patients can recognize menopause symptoms and seek treatment sooner.¹

View the complete and full guidance via Obstetrics & Gynecology, here.

References:

1. ACOG expands recommendations for management of menopause symptoms. American College of Obstetricians and Gynecologists. News release. October 15, 2026. Accessed October 15, 2026.
2. Management of menopause-related vasomotor, sleep, and mood symptoms. ACOG Clinical Practice Guideline No. 13. Obstet Gynecol. 2026;148(5):e345-e369.