Cited by 43Maternal Mental Health During Pregnancy and PostpartumTreatment of Major DepressionPregnancy and Medication Impact

Brexanolone for postpartum depression: clinical evidence and practical considerations

Leader, Lauren D., O'Connell, Megan, VandenBerg, Amy·2019·Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Abstract

Our aim was to review the efficacy, safety, and pharmacology of brexanolone (Zulresso), a new antidepressant with a novel mechanism of action, in the treatment of postpartum depression ( PPD ). Pertinent data and information were obtained via PubMed (1993 to August 2018). Articles published in English that evaluated the safety and efficacy of brexanolone and other off‐label PPD treatments were included. Literature regarding epidemiology and pathophysiology of PPD was also selected. Brexanolone, administered as an intravenous infusion over 60 hours, produced a statistically significant and clinically meaningful reduction in Hamilton Depression Rating Scale ( HAM ‐D) scores compared with placebo at both 60 and 90 μg/kg/hour in patients with moderate to severe PPD . Brexanolone groups had higher response and remission rates compared with placebo. Common adverse effects were somnolence, dizziness, and headache. A small percentage (4%) of patients required cessation of therapy due to excessive sedation or loss of consciousness. Although the evidence for brexanolone as a novel treatment for PPD looks promising, a Risk Evaluation and Mitigation Strategies ( REMS ) program requirement and the logistics of prolonged infusions serve as barriers to treatment. A discussion of these obstacles as well as pharmacokinetics, monitoring, and dosing is provided. Brexanolone is a novel antidepressant indicated for the treatment of PPD . Clinical trials demonstrated that brexanolone significantly reduces depression scores in women with moderate to severe PPD . Due to risk of oversedation and loss of consciousness, a REMS program will be put in place to mitigate the risk of adverse events.

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Registry

Crossref · 10.1002/phar.2331

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  • There is strong evidence that perinatal mental health conditions can be prevented and effectively treated through psychotherapy and/or pharmacotherapy.

    “Importantly, there is strong evidence that PMH conditions can be prevented52-54 and effectively treated through psychotherapy54-57 and/or pharmacotherapy.58,59”

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Authors
Leader, L. D., O'Connell, M., & VandenBerg, A.
Affiliations
  • Michigan Medicine (US)
  • Department of Pharmacy Services Michigan Medicine Ann Arbor Michigan
Corresponding author
Leader, Lauren D.
Venue
Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy
Publisher
Wiley
Published
2019-10-07
Volume
39
Issue
11
Pages
1105-1112
ISSN
  • 0277-0008 (ISSN-L)
  • 1875-9114
OpenAlex
W2972555063
Cited by
43
References
41
Citations by year
2026: 3 · 2025: 3 · 2024: 9 · 2023: 9 · 2022: 3 · 2021: 10 · 2020: 6
FWCI
0.78
Type
journal article
Language
en
Open access
closed
Locations
  • Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
Keywords
brexanolone, postpartum depression, antidepressants, intravenous infusion, treatment efficacy and safety, oversedation, loss of consciousness, pharmacokinetics, dosage, adverse effects, maternal mental health
MeSH terms
Antidepressive Agents, Drug Combinations, Female, Humans, Pregnancy, Pregnanolone, Psychiatric Status Rating Scales, Severity of Illness Index, GABA Modulators, Depression, Postpartum, beta-Cyclodextrins

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