Zolpidem

(Date: February 2018. Version: 1)

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 Public Health England 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.

What is it?

Zolpidem tartrate (Stilnoct®) is a type of sleeping tablet called a hypnotic that is sometimes prescribed for short periods of time to treat severe sleeping problems (insomnia). Whether you are pregnant or not, it is recommended that zolpidem is only used for short periods of time.

Is it safe to take zolpidem in pregnancy?

There is no yes or no answer to this question. When deciding whether or not to take zolpidem during pregnancy it is important to weigh up the benefits of its use against the known or possible risks, some of which will depend on how many weeks pregnant you are.

This leaflet summarises the scientific studies relating to the effects of zolpidem on a baby in the womb. It is advisable to consider this information before taking zolpidem if you are pregnant. For some women, treatment with zolpidem in pregnancy may be necessary.

Your doctor is the best person to help you decide what is right for you and your baby.

What if I have already taken zolpidem during pregnancy?

If you are taking any medicines it is always a good idea to let your doctor know that you are pregnant so that you can decide together whether you still need the medicines that you are on and to make sure that you are taking the lowest dose that works.

A small amount of scientific research suggests that zolpidem use in pregnancy might increase the chance of preterm delivery, low birth weight, and withdrawal symptoms in the baby at birth. These effects are likely to depend on when in pregnancy you took zolpidem, how much you took, and for how long. Your doctor will be able to recommend whether you or your baby need any additional monitoring or tests in pregnancy or after birth.

Can taking zolpidem in pregnancy cause my baby to be born with birth defects?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

No evidence that women who take zolpidem during early pregnancy have a higher chance of having a baby with a birth defect was provided by any of the three studies of a total of 1,667 pregnant women taking zolpidem. Studies of pregnant women who took other medicines that are chemically similar to zolpidem have also not provided convincing evidence of a link to having a baby with a birth defect.

Although these studies provide some reassurance, because only a small number of women have been studied, more information about women who have taken zolpidem during pregnancy is needed.

Can taking zolpidem in pregnancy cause miscarriage?

Studies that included a small number of women who took zolpidem during early pregnancy overall did not suggest any concerning findings relating to their chance of miscarriage. However, large, well designed studies of women who have taken zolpidem in early pregnancy are required before this can be confirmed.

Can taking zolpidem in pregnancy cause premature birth (before 37 weeks)?

Taking zolpidem during pregnancy has been linked in one large study to an increased chance of having a preterm baby. Two much smaller studies did not agree with this finding, but larger studies are generally considered more reliable than smaller studies. Use in pregnancy of medicines that are chemically related to zolpidem has also been shown to increase the chance of preterm birth.

Can taking zolpidem in pregnancy cause low birth weight?

Taking zolpidem during pregnancy has been linked in one large study to an increased chance of having a baby who is smaller than expected for the stage of pregnancy at delivery. Two much smaller studies did not agree with this finding, but larger studies are generally considered more reliable than smaller studies. The largest study found that the reduced birth weight was not just because the babies were born earlier. It is therefore possible that zolpidem use in pregnancy may slow down the baby’s growth in the womb but more research is needed to confirm whether this is the case, especially as the findings of the studies do not all agree.

Can taking zolpidem in pregnancy cause stillbirth?

Studies that included a small number of women who took zolpidem during pregnancy overall did not suggest any concerning findings relating to their chance of stillbirth. However, large, well designed studies of women who have taken zolpidem in pregnancy are required before this can be confirmed.

Can taking zolpidem in pregnancy cause other health problems in the child?

Withdrawal symptoms at birth (‘neonatal withdrawal’)
Withdrawal symptoms are thought to occur as the newborn baby’s body has to adapt to no longer getting certain types of medicines through the placenta.

One small study showed that newborn babies exposed in the womb to zolpidem did not have a higher chance of breathing problems, reduced muscle tone (‘floppy muscles’), lethargy, or of being treated in intensive care compared to unexposed newborn babies.

However, because zolpidem is similar to other medicines that are known to cause neonatal withdrawal, close monitoring of your baby for a few days after birth may be advised if you have taken zolpidem regularly in the weeks before delivery. 

Learning and behavioural problems
A baby’s brain continues to develop right up until the end of pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

No studies have been carried out to look at whether there is an increased risk of learning and behavioural problems in children who were exposed to zolpidem while in the womb.

Will my baby need extra monitoring?

As part of their routine antenatal care, most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects and to check the baby’s growth.

Your obstetrician may wish to monitor your baby’s growth more closely if you have taken zolpidem during pregnancy. Additionally, if you have taken zolpidem around the time of delivery, because of the risk of withdrawal symptoms in the baby, he/she may require extra monitoring after birth.

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

We would not expect any increased risk to your baby if the father took zolpidem before or around the time you became pregnant.

Who can I talk to if I have questions?

If you have any questions regarding 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.

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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