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Scientific article
Open access
English

Reproductive Safety of Trazodone After Maternal Exposure in Early Pregnancy : A Comparative ENTIS Cohort Study

Published inJournal of clinical psychopharmacology, vol. 43, no. 1, p. 12-19
Publication date2023-02-01
First online date2023-02-01
Abstract

Purpose/background: Trazodone is indicated for the treatment of major depressive disorder, but more frequently prescribed off-label at lower doses for insomnia in women of childbearing age. The aim of this study was to assess the risks linked to trazodone exposure during pregnancy for which limited safety data are available.

Methods/procedures: This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to trazodone in early pregnancy against those in a reference group of women exposed to a selective serotonin reuptake inhibitors (SSRIs) between 1996 and 2021.

Findings/results: The sample included 221 trazodone and 869 SSRI-exposed pregnancies. Exposure to trazodone in the first trimester was not associated with a significant difference in the risk of major congenital anomalies (trazodone [1/169, 0.6%]; SSRI [19/730, 2.6%]; adjusted odds ratio, 0.2; 95% confidence interval, 0.03-1.77). The cumulative incidences of live birth were 61% and 73% in the trazodone and reference group, respectively (25% vs 18% for pregnancy loss and 14% vs 10% for pregnancy termination). Trazodone exposure was not associated with a significantly increased risk of pregnancy termination and pregnancy loss. The rate of small for gestational age infants did not differ between the groups.

Implications/conclusions: This study did not reveal a significant difference in the risk of major congenital anomalies after first trimester exposure to trazodone, compared with SSRI exposure. Although this study is the largest so far, these results call for confirmation through further studies.

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Keywords
  • Pregnancy
  • Female
  • Humans
  • Cohort Studies
  • Trazodone / adverse effects
  • Maternal Exposure
  • Prospective Studies
  • Depressive Disorder, Major
  • Pregnancy Complications / drug therapy
  • Pregnancy Complications / epidemiology
Citation (ISO format)
DAO, Kim et al. Reproductive Safety of Trazodone After Maternal Exposure in Early Pregnancy : A Comparative ENTIS Cohort Study. In: Journal of clinical psychopharmacology, 2023, vol. 43, n° 1, p. 12–19. doi: 10.1097/JCP.0000000000001630
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Article (Published version)
Identifiers
ISSN of the journal0271-0749
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