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Brexanolone

Published: July 26, 2026Updated: August 24, 2026

Brexanolone is a neuroactive steroid medication specifically approved for the treatment of postpartum depression in adults. It works by modulating GABA-A receptors in the brain, which helps alleviate the severe depressive symptoms associated with postpartum depression. This medication requires administration as a continuous intravenous infusion over approximately 60 hours in a certified healthcare setting due to the risk of excessive sedation and sudden loss of consciousness.

Quick summary

Brexanolone is a prescription neuroactive steroid used to treat postpartum depression via continuous IV infusion.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 24, 2026Editorial policy

Key facts at a glance

ATC
N06AX29
RxNorm
2121777
Generic
Brexanolone
Class
atc-n06
Brands
Zulresso
Availability
rx
Lactation
unknown
Routes
—
Forms
injection
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose significantly exceeding recommended infusion rate may cause serious toxicity
Chronic overdose: cumulative exposure above recommended dosing schedule over 60-hour infusion period
Immediate actions
discontinue infusion immediately, maintain airway and ventilation, monitor cardiac and respiratory status, supportive care
Antidote
flumazenil may be considered for severe sedation(limited evidence for effectiveness, supportive care is primary treatment)
Poison Control: 1-800-222-1222

Special Populations

8 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during first trimester unless benefits outweigh risks

Monitor

regular fetal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

use with caution

Key Recommendations

may be used for postpartum depression near term if benefits outweigh risks

Monitor

fetal monitoring and assessment of neonatal sedation

Use with caution and monitor for adverse effects.

⚠

lactation

breastfeeding
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

brexanolone passes into breast milk; decide whether to discontinue breastfeeding or discontinue drug

Monitor

monitor infant for excessive sedation

Use with caution and monitor for adverse effects.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

dose reduction recommended

Key Recommendations

start at lower end of dosing range; increased risk of sedation and falls

Monitor

monitor for sedation, dizziness, and falls

Use with caution and monitor for adverse effects.

✗

pediatric_age

under 18 years
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

safety and efficacy not established in patients under 18 years of age

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
N
Dose Adjustment

dose adjustment may be required

Key Recommendations

use with caution; monitor for drug accumulation

Monitor

monitor renal function and adverse effects

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate hepatic impairment
caution
FDA Category
N
Dose Adjustment

dose reduction recommended

Key Recommendations

reduce starting infusion rate; monitor for prolonged sedation

Monitor

monitor liver function and sedation levels

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe hepatic impairment
unsafe
FDA Category
N
Dose Adjustment

avoid use

Key Recommendations

not recommended in severe hepatic impairment due to significantly reduced clearance

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2019

Year of FDA approval for postpartum depression treatment

drug_classFDA
2023

Drug class

Value:GABA-A receptor positive allosteric modulator

Mechanism of action classification

usageFDA
2023

Primary indication

Value:Postpartum depression

Therapeutic indication

administrationFDA
2023

Administration route

Value:Intravenous infusion

Method of drug delivery

Brexanolone is indicated for the treatment of moderate to severe postpartum depression in adults. Postpartum depression is a serious mental health condition that affects some individuals following childbirth, characterized by persistent sadness, anxiety, fatigue, and difficulty bonding with the newborn.

Brexanolone is an analogue of allopregnanolone, a naturally occurring neurosteroid. It acts as a positive allosteric modulator of GABA-A receptors in the brain, enhancing inhibitory signaling. This modulation helps restore hormonal balance and improve mood by counteracting the neurosteroid withdrawal that may contribute to postpartum depressive symptoms.

Brexanolone must be administered as a continuous IV infusion over 60 hours in a certified healthcare facility with monitoring due to risks of excessive sedation, sudden loss of consciousness, and hypoxia. Patients require continuous electronic monitoring and should not be left alone during treatment. The medication is administered as a single course and is not indicated for other forms of depression.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy