Zopiclone

(Date: August 2022. Version: 2)

This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by the UK Health Security Agency (UKHSA) on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.

Quick read

Zopiclone is occasionally used in pregnancy if other methods have failed to treat a severe sleeping problem.

What is it?

Zopiclone (Zimovane®) is a type of sleeping tablet called a hypnotic that is sometimes prescribed for short periods of time to treat severe sleeping problems (insomnia).

What are the benefits of taking zopiclone in pregnancy?

Zopiclone helps with sleeping problems and can therefore greatly improve wellbeing and quality of life. Zopiclone may occasionally be offered in pregnancy if other methods to improve sleep have not worked.

What are the risks of taking zopiclone in pregnancy?

There is no strong evidence to show that zopiclone used in early pregnancy causes birth defects in the baby.

Some studies have shown that pregnant women taking zopiclone and similar drugs have a higher chance of premature delivery and a baby with a low birth weight. However, it is unclear if these were direct effects of zopiclone or due to other factors that are more common in women taking this medicine.

Zopiclone can cause short-term withdrawal symptoms in the newborn baby if taken in the weeks before delivery. For this reason, a baby may be monitored for some time after birth to check for symptoms such as jitteriness, difficulty sleeping and breathing problems.

Are there any alternatives to taking zopiclone in pregnancy?

Yes, usually. Sleep problems can sometimes be improved using non-drug methods and there are also alternative types of medication that might help. Women planning a pregnancy or who become pregnant while taking zopiclone should discuss their treatment with a doctor.

What if I prefer not to take zopiclone in pregnancy?

Your doctor will help you explore other options to help with sleeping. Medicines will only be prescribed during pregnancy when necessary and a doctor will be happy to talk about any concerns.

Will I or my baby need extra monitoring?

In the UK, all women will be offered a very detailed scan at around 20 weeks of pregnancy as part of their routine antenatal care. No additional monitoring of the baby is required due to use of zopiclone.

Are there any risks to my baby if the father has taken zopiclone?

There is no evidence that zopiclone used by the father can harm the baby through effects on the sperm.

Who can I talk to if I have questions?

If you have any questions about the information in this leaflet, please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system allows women with a current or previous pregnancy to create a digitally secure ‘my bumps record’. You will be asked to enter information about your health, whether or not you take any medicines, and your pregnancy outcome. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit https://www.medicinesinpregnancy.org/Login/ to register.

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General information 

Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks.  They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.

Medicines use in pregnancy

Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby.  There are, however, some medicines that can harm a baby’s normal development.  How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.

If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.

When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.   

Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.

   

www.medicinesinpregnancy.org

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.

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