Benzodiazepines and non-benzodiazepine hypnotics are commonly used during pregnancy. However, there data regarding the reproductive safety of these agents has been somewhat mixed. Although initial reports suggested that there may be an increased risk of cleft lip and palate, more recent reports have shown no association between exposure to benzodiazepines and risk for cleft lip or palate. A new study shows no increase in the overall risk of malformations among children exposed to benzodiazepines.
In this study, singleton children born to women aged 15-45 years between 1990 and 2010 were identified using a large United Kingdom primary care database. The absolute risks of major malformations were calculated for children with first trimester exposure to different anxiolytic and hypnotic drugs. Overall the prevalence of malformations was:
- 2.7% in 1,159 children exposed to diazepam (Valium)
- 2.9% in 379 children exposed to temazepam (Restoril)
- 2.5% in 406 children exposed to zopiclone (not available in the US although its active stereoisomer, eszopiclone, is sold as Lunesta)
As a comparison group, the authors selected 19,193 children whose mothers had diagnosed depression and/or anxiety but no first trimester drug exposures. The rate of malformations in this comparison group was 2.7%.
This study indicates no evidence for an increase in malformations in children exposed to benzodiazepines and non-benzodiazepine hypnotics in the first trimester of pregnancy. This data is reassuring when considering the reproductive safety of benzodiazepines as a class of medications; however, we would like to have more data on other benzodiazepines, such as clonazepam (Klonopin) and lorazepam (Ativan), which are used more commonly in the United States.
Ruta Nonacs, MD PhD
Ban L, West J, Gibson JE, Fiaschi L, Sokal R, Doyle P, Hubbard R, Smeeth L, Tata LJ. First trimester exposure to anxiolytic and hypnotic drugs and the risks of major congenital anomalies: a United kingdom population-based cohort study. PLoS One. 2014 Jun 25;9(6):e100996.