Last reviewed:December 2019
Last updated:July  2019
11 Jul 2019

US FDA approves brexanolone, the first drug approved specifically to treat postpartum depression

  • The Food and Drug Administration (FDA) has approved brexanolone - the first-ever approval of a drug specifically to treat postpartum depression.

  • Brexanolone is a synthetic version of the natural neurosteroid allopregnanolone, and binds to gamma-aminobutyric acid (GABA) type A receptors.

  • Brexanolone is given by continuous intravenous infusion over a total of 60 hours (2.5 days).

  • The efficacy of brexanolone was evaluated in one phase 2 and two phase 3 trials in women with severe or moderate postpartum depression. In all three studies, women treated with brexanolone showed a greater improvement in depressive symptoms from baseline (using the Hamilton Rating Scale for Depression) than controls at the end of the first infusion (60 hours).[88][89] The phase 2 trial also showed a statistically significant benefit at 30 days.[88]

  • The most common side effects in the brexanolone groups were headache, dizziness, and somnolence.

  • Because of concerns about potential serious risks during infusion, including excessive sedation or sudden loss of consciousness, brexanolone is only available through a Risk Evaluation and Mitigation Strategy (REMS) at certified medical facilities. Women having the infusion must be monitored continuously, and be accompanied during any interactions with their children.

  • The place of brexanolone in the treatment of postpartum depression is still considered emerging by most experts.

See Management: emerging

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History and exam

Key diagnostic factors

  • depressed mood
  • anhedonia
  • decreased energy or increased fatigability
  • suicidal ideation
  • loss of confidence or self-esteem
  • unreasonable feelings of self-reproach or excessive and inappropriate guilt
  • poor concentration

Other diagnostic factors

  • change in psychomotor activity
  • sleep disturbance
  • change in appetite
  • change in weight
  • obsessive thoughts
  • significant self-harm or neglect or mistreatment of children
  • personal or family history of hypomania or mania
  • psychotic symptoms

Risk factors

  • history of depressed mood, depression, or anxiety
  • recent stressful life events
  • poor social support
  • discontinuation of psychopharmacologic treatments
  • sleep deprivation
  • postpartum hypomania
  • personality disorder
  • birth complications
  • poor socioeconomic status
  • age less than 16 years
  • familial and genetic factors
  • violence by partner during pregnancy

Diagnostic investigations

Treatment algorithm


Clinical Senior Lecturer

MRC Centre for Neuropsychiatric Genetics and Genomics

Cardiff University




ADF is an author of references cited in this topic.

Professor of Psychiatry

MRC Centre for Neuropsychiatric Genetics and Genomics

Cardiff University




IJ has received honorariums or consultancy fees from Lilly, GlaxoSmithKline, Lundbeck, Sanofi-Aventis, Janssen-Cilag, and AstraZeneca, and has received research funding from GlaxoSmithKline. IJ is also an author of references cited in this topic.

Peer reviewersVIEW ALL

Associate Professor of Psychiatry

Columbia University

New York



MS declares that she has no competing interests.

Head of the Perinatal Psychiatry Network

University Department of Adult Psychiatry

CH Charles Perrens




ALS declares that she has no competing interests.

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