SUMMARY: Dosulepin (formerly known as dothiepin) is a tricyclic antidepressant used in the treatment of depression, particularly where sedation is required. 

There is very little published data regarding the use of dosulepin in pregnancy.  Neonatal withdrawal symptoms may occur following chronic use or use near the time of delivery of any antidepressant.  The neonate should be monitored for adverse effects such as drowsiness, jitteriness, hyperexcitability and suckling problems.  Some studies have suggested that exposure to tricyclic antidepressants (TCAs) and other antidepressants in pregnancy may be associated with an increased risk of spontaneous abortion, low birth weight and IUGR.  However, there is evidence to suggest that the maternal condition may contribute to these findings. 

The very limited published data, and data collected by UKTIS, do not indicate an increased risk of congenital malformation or adverse fetal outcome following in utero exposure to dosulepin, however data are insufficient to state that there is no risk.  Inadvertent exposure to dosulepin at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. 

Please report ALL cases of drug and/or chemical exposure in pregnancy to UKTIS by telephoning the service on 0844 892 0909 or by printing and completing a pregnancy reporting form, providing as many patient identifiers as possible to enable follow up of pregnancy outcome. This vital information enables UKTIS to provide evidence based advice for future enquiries and to conduct surveillance of potential and known teratogens. For case specific advice please contact UKTIS on 0844 892 0909.