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FDA Approved
Prescription Medicine

SSRIs for Hot Flashes

A low-dose SSRI (paroxetine 7.5 mg) approved by the FDA for moderate-to-severe hot flashes.

Last verified:

SSRIs for Hot Flashes (Prescription Medicine)
Method at a Glance
EfficacyRecommended
see details
DurationDaily pill (ongoing)
Cost$0–$200
/monthly
Used forHot flash & night sweat relief
PrescriptionRequired
Available Products

1 product in this category

Specific branded items that use this method. Compare manufacturer details, active ingredients, and regulatory status.

The details

What the evidence says

How well it works, what to watch for, who should avoid it, and the studies behind it.

How well it works
Recommended

Recommended by the Menopause Society for symptom relief.

How was this measured?

Phase 3 trials (n=1184, baseline ~10 moderate-to-severe hot flushes/day): median reduction of 5.6-5.9 episodes/day at week 12 vs 3.9-5.0 with placebo; median treatment difference 0.9-1.7 episodes/day. The FDA label reports reductions in daily episodes rather than a percentage. The FDA describes the effect as modest. NAMS 2023 Level I recommendation.

Cost & insurance
$0–$200/monthly

Paroxetine tablets for hot flashes typically cost around $200/month for brand-name products; generic paroxetine is cheaper.

Insurance CoverageUsually
Duration & reversibility
Lasts forDaily pill (ongoing)
Reversibility
Reversible
The science
Clinical classSSRI (paroxetine)
How it works in the body

Low-dose paroxetine affects serotonin and other neurotransmitters involved in temperature regulation, which can reduce hot flash frequency and severity.

Regulatory status
StatusFDA Approved
Used forHot flash & night sweat relief
PrescriptionRequired
Side effects
  • Nausea
  • Headache
  • Fatigue or malaise
Who shouldn't use this
  • Current or recent MAOI use (within 14 days)(Taking MAO inhibitor antidepressants in the last two weeks)
  • Concomitant thioridazine or pimozide(Taking these medicines with paroxetine can cause serious heart rhythm problems)
  • Pregnancy(The treatment is not intended for use during pregnancy and may harm a fetus)
  • Hypersensitivity to paroxetine or any ingredient(An allergy or sensitivity to the medicine, device, or one of its ingredients)
Clinical Guidelines
NAMS

2023 Position Statement - Level I recommendation for hot flashes and night sweats

View Guideline
The full picture

What to know about SSRIs for Hot Flashes

How it works

Low-dose paroxetine (7.5 mg) is approved by the FDA for moderate-to-severe menopause hot flashes and night sweats. It works by affecting serotonin and other neurotransmitters involved in temperature regulation, which can reduce hot flash frequency and severity.

How well it works

In Phase 3 trials (n=1184), paroxetine 7.5 mg reduced daily hot flash frequency by a median of 5.6 to 5.9 episodes per day at 12 weeks, compared to 3.9 to 5.0 with placebo. The median treatment difference was 0.9 to 1.7 episodes per day, which the FDA described as a modest effect. The Menopause Society (NAMS 2023) lists it as a Level I recommendation. Other SSRIs and SNRIs are also used off-label for hot flashes, but low-dose paroxetine has FDA approval for this use.

Side effects and cautions

Paroxetine carries an FDA boxed warning about suicidal thoughts and behaviors, which applies to antidepressants including the low dose used for hot flashes. Paroxetine should not be taken within 14 days of using an MAOI antidepressant or with thioridazine or pimozide. Use caution if you take tamoxifen for breast cancer, because paroxetine inhibits the CYP2D6 enzyme that converts tamoxifen to its active form. If you have severe liver disease, talk to your clinician about whether paroxetine is appropriate and what dose is safe. Common side effects include nausea, headache, and fatigue or malaise.

Where to get it

You need a prescription, which you can get through telehealth or your primary care provider. You take it as a daily pill at bedtime.

The studies

Clinical trials behind SSRIs for Hot Flashes

The research that backs SSRIs for Hot Flashes, with links to the public trial records.

Phase 3Completed

Paroxetine 7.5 mg Phase 3 Trial 1 (NCT01101841)

ClinicalTrials.gov: NCT01101841
Phase 3Completed

Paroxetine 7.5 mg Phase 3 Trial 2 (NCT01361308)

ClinicalTrials.gov: NCT01361308
Phase 2Completed

Paroxetine 7.5 mg Phase 2 Trial 3 (NCT00786188)

ClinicalTrials.gov: NCT00786188