Use of agomelatine in pregnancy

Date: December 2022, Version 3

Quick read

Agomelatine may occasionally be used in pregnancy if it is the best medicine to treat a woman’s depression.

What is it?

Agomelatine (Valdoxan®) is used to treat depression.


What are the benefits of using agomelatine in pregnancy?

Agomelatine can improve your mood and feelings of wellbeing. It is very important that mental health conditions are treated to ensure a woman is well during pregnancy and while looking after her baby.


What are the risks of using agomelatine in pregnancy?

There are no studies of pregnant women who take agomelatine so it is unclear if it might affect the baby’s development.

Agomelatine works through effects on the brain and might therefore 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 jitteriness, difficulty sleeping, and breathing and feeding problems.


Are there any alternatives to using agomelatine in pregnancy?

Possibly. Other medicines can be used to treat depression, so switching may be an option. For some people, talking therapies can be helpful but this does not work for everyone and some may prefer to take a medicine. If a woman’s condition is well-controlled with agomelatine, it may be safer overall to stay on it rather than try something new and risk a relapse.

Ideally, a woman planning a pregnancy should speak to her GP or specialist to determine whether agomelatine is still the best option. Similarly, women who have an unplanned pregnancy while taking agomelatine should be reviewed at the earliest opportunity by their GP or specialist.

No treatment

What if I prefer not to take medicines during pregnancy?

It is very important that mental health conditions are well-controlled during pregnancy. Discontinuing antidepressant medication can cause symptoms to return and stopping suddenly can cause withdrawal symptoms.

A medicine will only be prescribed during pregnancy if it is absolutely necessary, and a doctor or specialist will be happy to discuss the benefits and any risks.

Please do not stop agomelatine without speaking to your midwife, GP, or specialist.

Will I or my baby need extra monitoring?

All pregnant women in the UK should be offered a detailed anomaly scan at around 20 weeks of pregnancy as part of their routine antenatal care. Because this scan is so thorough, extra monitoring for birth defects is not usually required following agomelatine use in pregnancy.

Are there any risks to my baby if the father has used agomelatine?

We would not expect any increased risk to your baby if the father took agomelatine 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 healthcare provider. They can access more detailed medical and scientific information from

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

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. 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 the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.