Trazodone is a triazolopyridine antidepressant drug used in the treatment of anxiety and depressive disorders, particularly where sedation is required.
Data are limited to a small number of trazodone-exposed pregnant women and providing an estimate on the likelihood of adverse outcomes following exposure during pregnancy is not currently possible. However, there is currently no evidence to suggest that exposure to trazodone is associated with an increased risk of congenital malformation, miscarriage or stillbirth/intrauterine death, preterm delivery or low infant birth weight.
It is important to ensure that maternal mental health disorders are treated appropriately during pregnancy. Where a patient is stabilised on trazodone, either prior to conception or during pregnancy, the risk of discontinuing or changing medication, or reducing the dose, should be carefully weighed against the risk of relapse of the maternal condition. Where use of trazodone in pregnancy is considered clinically necessary, patients should be made aware of the limitations of the existing pregnancy safety data and the lowest effective dose used.
Studies have suggested that use of antidepressants for the treatment of depression during pregnancy may be associated with an increased risk of miscarriage, low birth weight and intrauterine growth restriction. However, there is also evidence to suggest that maternal depression may independently contribute to these findings and a causal link to antidepressant medications is thus unconfirmed.
An increased risk of poor neonatal adaptation syndrome (PNAS) has been reported following chronic use or use near the time of delivery of other antidepressants; monitoring of the neonate for symptoms suggestive of withdrawal is therefore advised. These symptoms are likely to be more severe in infants exposed in utero to more than one CNS acting drug.
Exposure to trazodone at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or an indication for additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.