• Postpartum depression.

Contraindicated in:

• End-stage renal disease (CCr <15 mL/min) (↑ accumulation of solubilizing agent).

Use Cautiously in:

• OB: Safety not established
• Lactation: Enters breast milk; use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: May ↑ risk of suicidal thoughts/behaviors
• Pedi: Children <15 yr (safety and effectiveness not established).

CV: tachycardia.

Derm: flushing.

GI: dry mouth, diarrhea, dyspepsia, oropharyngeal pain.

Neuro: dizziness, presyncope, sedation, vertigo, altered consciousness, loss of consciousness, SUICIDAL THOUGHTS/BEHAVIORS.

Drug-Drug:

• Use with benzodiazepines or other CNS depressants, including opioids, non-benzodiazepine sedative/hypnotics, anxiolytics, muscle relaxants, and alcohol may cause profound sedation, loss of consciousness, and/or respiratory depression; avoid concurrent use, if possible.

• Solution for injection: 5 mg/mL;

• IV (Adults and Children 15 yr): 30 mcg/kg/hr for 4 hr, then ↑ to 60 mcg/kg/hr for 20 hr, then ↑ to 90 mcg/kg/hr for 28 hr, then ↓ to 60 mcg/kg/hr for 4 hr, then ↓ to 30 mcg/kg/hr for 4 hr, then discontinue. Total duration of infusion = 60 hr.

Zulresso

• Although not fully understood, thought to be related to positive allosteric modulation of GABA-A receptors.

• Reduction in depressive symptoms.

Therapeutic Classification: antidepressants

Pharmacologic Classification: corticosteroids

Absorption: IV administration results in complete absorption.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Extensively metabolized via keto-reduction, glucuronidation, and sulfation to inactive metabolites. Primarily excreted in feces (47%) and urine (42%) as metabolites.

Half-life: 9 hr.

Schedule IV (C-IV)

(reduction in depressive symptoms)

• REMS: Explain purpose of medication to patient and family and requirements of Zulresso REMS program. Advise patient to read Medication Guide before starting brexanolone.
• Advise patient to notify health care professional if excessive sedation occurs during infusion. Patients must not be the primary caregiver of dependents and must be accompanied during interactions with their child(ren).
• Caution patient to avoid driving and activities requiring alertness until response from medication is known.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Advise patient to avoid taking other CNS depressants or alcohol.
• Advise females of reproductive potential to notify health care professional if they could possibly be pregnant prior to therapy. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Encourage patient to enroll in the registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. To register patients, healthcare professionals should call the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/.

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