USE OF ZOLPIDEM IN PREGNANCY

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(Date of issue: November 2013, Version: 2)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on zolpidem use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Zolpidem is a short-acting non-benzodiazepine hypnotic agent which acts on benzodiazepine receptors.  It is indicated in the short-term treatment of patients with debilitating insomnia, or where insomnia is causing severe distress.

There are few data available concerning the use of zolpidem in human pregnancy.  These data do not currently suggest an increased risk of congenital malformation but are considered too limited to state that no risk exists.

Associations between in-utero zolpidem exposure and increased risks of preterm delivery and low birth weight have been reported.  However, the number of studies these findings are based on is small, and in one study the association with impaired fetal growth was no longer present following correction for the gestational age of the infant at delivery.  The data concerning the effects of zolpidem on intrauterine growth are both conflicting and limited, and a link between the two remains unconfirmed.  Maternal use of benzodiazepines and/or non-benzodiazepine hypnotic benzodiazepine receptor antagonists as a group has also been linked in one study with an increased risk of preterm birth.  It is not clear whether these findings are observed as a medication class effect or as a result of data confounding.  Further studies are required before firm conclusions regarding an association with any of the above outcomes can be provided.

As with all centrally acting drugs, neonatal withdrawal symptoms may be expected following maternal use of zolpidem either throughout pregnancy or in the weeks preceding delivery.

Although no definitive evidence-based recommendations regarding fetal monitoring can be made on the currently available data, enhanced monitoring of fetal growth may be prudent where exposure to zolpidem in pregnancy has been prolonged.  Other risk factors which may independently increase the risk of adverse pregnancy outcome may also be present in individual cases.  Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.  Discussion with UKTIS is recommended in all cases of zolpidem exposure.

This document is regularly reviewed and updated.  Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to be sure you are using the most up-to-date version.

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 health care professionals at www.toxbase.org.

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.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.