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Agomelatine

  • Medication name

    Agomelatine ("ag-o-mel-a-teen")

  • Brand name

    Valdoxan ("val-DOX-an")

  • Medication type

    Atypical antidepressant

Tablets: 25mg strength only

If you are 18 or over, your doctor can prescribe you agomelatine as a licensed medicine for depression.

If you are under 18, a specialist doctor may still consider this as a treatment option. This may be because other medicines haven’t worked for you, or because you’ve found the side effects of other medicines difficult to tolerate.

Read our guide to depression

About agomelatine

Agomelatine is an antidepressant used to treat depression.

The brain is usually good at making sure we have enough of the chemicals we need to function properly. But depression can affect our brain chemicals, including noradrenaline, dopamine and serotonin.

Dopamine and noradrenaline are naturally occurring chemical messengers (or ‘neurotransmitters’) that have an important role in areas of the brain that control mood, thinking, feelings and emotions. Depression can reduce the levels of these brain transmitters.

Depression also affects a chemical called melatonin, which is linked to your sleep patterns.

Agomelatine can increase melatonin activity directly. It does this by acting like melatonin at the melatonin receptors (the target sites where melatonin works). By increasing melatonin activity, agomelatine also directly increases activity of noradrenaline and dopamine.

Depression, and other conditions like anxiety disorders, are not just caused by low levels of neurotransmitters, but a rise in these can improve symptoms and help you to feel better.

Agomelatine and everyday life

Agomelatine should start helping with depression within one to two weeks. It may take four weeks or longer for you to get the full effect.
Your doctor will probably start you on the standard dose of 25mg a day and then increase it to 50mg after two weeks if there has not been much improvement.

How people respond to treatment can vary. Sometimes improvement is slow, and you may not feel any different to start with. This can be hard when your mood is low, and if you experience any side effects form your medication you may think you feel worse and not better. If you can, give your medication a chance to work and continue to take it for at least three to four weeks to see if it makes a difference.

Your parents, friends and doctor may notice an improvement in you before you feel it yourself, so it’s a good idea to talk to them.

If you think your medicine has not made any difference to how you feel after three to four weeks, you should go back to your doctor. They might recommend a change in dose or a different medication. However, it can take longer to work for some people than for others, so they may suggest you wait six to eight weeks before deciding.

Some people find that, in the long term, they gain a little weight while taking agomelatine. This may be due in part to their appetite returning.

Some people may find that their weight goes down while taking agomelatine, although this is rarer.

It is not possible to predict how agomelatine will affect each person before they start taking it. Talk to your doctor or pharmacist if you are concerned about your weight, or changes to your weight, while taking agomelatine.

You may want to let your family and friends know you are taking agomelatine so they can support you and help you look out for side effects.

For guidance on this, check out our page on getting support with your medication.

Agomelatine may make you feel drowsy for a few days after you start taking it. This should pass after the first week or two. It is recommended that you take this medicine at bedtime.

Insomnia is also a commonly reported side effect of this medicine.

Talk to your doctor or pharmacist if you are concerned about how agomelatine is affecting your sleep.

If you have been taking agomelatine for more than a month and you continue to feel very tired, sleepy or unable to function well during the day, you should go back to your doctor and discuss what changes could be made to help. This may include switching to a different medication.

Alcohol

It may be possible to drink alcohol in small amounts while taking agomelatine. But the two together might make you feel very sleepy and unsteady on your feet, especially when you first start taking the medication.

During the first few weeks of treatment, it is recommended that you don’t drink alcohol until you know how the medicine affects you.

Drinking alcohol every day, or in large amounts, can make your symptoms worse and may mean you won’t get the maximum benefit from your medication.

Street drugs

Using cannabis while on agomelatine can make drowsiness worse and slow your reaction time.

Cannabis and other drugs may have their own side effects on your mental health, like anxiety or psychosis.

Using heroin or methadone while on agomelatine can make drowsiness worse.

There are many other street drugs, but we don’t know what effect taking them with agomelatine will have, so it’s best to be cautious.

There is no regulation of street drugs or ‘legal highs’, so even if there are no known issues with the medication you take, the supply you receive might be mixed with other substances that could be dangerous.

Smoking

Smoking affects the level of agomelatine in your body. If you smoke, then your body breaks agomelatine down more quickly. This means you may need a higher dose for the medicine to be effective.

If you stop smoking while taking this medicine, then your agomelatine levels will go up, meaning you may need to lower your dose so you don't get side effects.

Moving to nicotine replacement therapies or vaping will have the same effect on agomelatine levels as stopping smoking. This is because it is the chemicals in the smoke that cause your liver to break down the agomelatine more quickly.

Your doctor can give you advice and help with stopping smoking.

Get more advice on drugs and alcohol.

Agomelatine does not mix well with some other medicines, including herbal remedies. It may affect how they work or could cause more side effects. Always talk to your doctor if you are taking other medicines.

Do not take agomelatine if you are taking the herbal remedy St. John's Wort. St. John's Wort is a herbal medicine available over the counter in shops that can also be used for low mood. It does not mix well with any antidepressant, so please tell your doctor or pharmacist if you are trying this or want to try it.

Before you start taking agomelatine, tell your doctor if you are taking any other medications, including things you have bought from a pharmacy or other shop for common illnesses like colds and flu or medications that you put on your skin.

Always tell the pharmacist that you are taking agomelatine if you buy any medicines from a pharmacy.

Look at the leaflet inside your medicine box for more information about other medicines that can interact with agomelatine. With some medicines your doctor may need to adjust the dose of your medicines if you take them together. Ask a doctor or pharmacist for more information if you have any questions.

The tablets may not be suitable for you if you have problems eating some sugars or dairy foods, as the Valdoxan brand of agomelatine contains lactose.

Always let your pharmacist know if you have any food allergies or intolerances, and always check with them if you’re concerned about any of the ingredients in your medication.

If you need to avoid animal products such as gelatine, please note that this is often found in capsules but also in some tablet formulations. Ask your pharmacist if you have any questions about the ingredients. Find out more on the Vegan Society website.

Do not drive a car or ride a bike just after you start taking agomelatine.

Taking agomelatine may affect your ability to do things like drive a car, ride a bike, or anything else that needs a lot of focus. It might be best to stop doing these things for the first few days or weeks until you know how it affects you.

Most people drive as normal while taking agomelatine. If you are worried about this or have any concerns you would like to discuss, speak to your doctor or pharmacist.

Pregnancy

There is no evidence to suggest that taking agomelatine while you are pregnant is harmful, but there is not much information available.

If you do become pregnant while you are on agomelatine, you should carry on taking your medicine and speak to your doctor about this as soon as possible. They can discuss the benefits and risks of continuing agomelatine and help you to make a decision that is best for you and your baby. They may refer you to a specialist perinatal mental health team to support you with this decision. You can find out more information about taking agomelatine during pregnancy at Bumps (Best Use of Medicines in Pregnancy).

Untreated depression or anxiety can also be harmful to you and your developing baby, so decisions about stopping or avoiding medication when you are pregnant need to be discussed carefully with your doctor. If you and your doctor agree that it is best for you to continue taking agomelatine while pregnant, you should tell your midwife. If you are planning to get pregnant, it is recommended that you take folic acid while you are trying for a baby and during pregnancy. It is safe to take this together with agomelatine.

Breastfeeding

There is no specific information about whether agomelatine is passed on to the baby through breastmilk, but since this is the case with most other drugs, it is likely that it is also the case with agomelatine.

If your baby was born early, then breastfeeding is not recommended as your baby may not safely be able to get rid of the agomelatine. Talk to your midwife and doctor about feeding options.

If you breastfeed while taking agomelatine and your baby becomes restless, very sleepy or develops feeding problems, seek medical advice urgently.

Sex

Agomelatine is unlikely to cause side effects that will directly affect your sex life.

Untreated depression or anxiety can have a negative effect on your sex life, so if agomelatine helps you to recover, positive effects can include improving your desire, experience and enjoyment of sex as your mood lifts and you become interested in life and relationships again.

Fertility

There is no evidence to suggest that taking agomelatine will affect your fertility.

Agomelatine will not affect how contraceptive pills or the 'morning after' pill work. Contraceptive pills containing oestrogen are likely to increase the level of agomelatine in your body, but studies have shown that there is no need to reduce your dose of agomelatine.

Taking agomelatine should not affect your periods.

Talk to your doctor about agomelatine if you are trying to get pregnant or planning a family.

Agomelatine is not a banned substance in sport.

Most people play sports as normal while taking agomelatine. However, it may affect your ability to play sports that require a lot of focus. It might be best to stop these sports for the first few days until you know how it affects you or the effects get better.

If you have any concerns, discuss this with your doctor.

Ideally it’s best  not to take agomelatine for the first time just before your exams, as it may affect your concentration.

It’s not possible to predict how the medication will make you feel, and if you do get any side effects, these are more likely to occur when you first start taking agomelatine.

You should talk to your doctor about any future exams if you are starting agomelatine. You might decide together to delay starting it until you have done them.

If they are more than a month away, however, you might find that it is better to start agomelatine to improve your motivation and ability to study. Bear in mind that depression itself can also affect concentration.

Most people take exams as normal while taking agomelatine, but if you have any concerns, discuss this with your doctor.

Information and safety considerations

Your doctor will consider any other medical conditions or symptoms you have before recommending a medicine for you.

Your medicine will come with a ‘patient information leaflet’. It’s important that you read this information. Speak to your pharmacist if:

  • you’re not given a leaflet
  • you don’t understand the information
  • you need it in a different format or language
  • you’re concerned about something you’ve read

The information leaflet also includes a list of warnings and precautions to consider before you take the medicine. If you think that any of these apply to you and are concerned that your doctor is not already aware of them, check with your doctor or pharmacist before you start to take your medication (or as soon as possible if you are already taking it).

Uses, warnings, safety and side effects

Taking agomelatine

Your doctor will advise you on how long it is best to keep taking your medication. This may vary depending on what you’re taking it for and how many times you’ve been unwell.

It is recommended that you take agomelatine for at least six months after you feel well again. This means that most people take it for at least seven to nine months. Research has shown that stopping it sooner, or immediately after you start to feel better, increases the risk of your low mood returning.

If you have had low mood or depression more than once, or if there is a higher risk of you becoming unwell again, your doctor may advise you to continue taking agomelatine for two years after you feel well again.

You will get the best effect from agomelatine if you take it regularly every day at the dose prescribed by your doctor.

You should start by taking agomelatine in the evening. This will help with your sleep.

To make sure you take your medication at the same time every day, try to get into a routine, like taking it when you have supper or brush your teeth.

You can take it before or after food – it doesn't matter.

Swallow the tablet with a drink of water or liquid – if you chew it, it tastes bitter.

If you forget to take a dose, then just take it as soon as possible.

If you realise you forgot to take your last dose by the time you are due to take your next dose, only take your next dose. Do not try and catch up by taking a double dose.

If you forget to take your agomelatine for a few days, you may start to lose any positive affects you have seen while taking it.

If you regularly forget to take it every day, your medicine may not work as well, and it could increase the risk of you becoming unwell again.

Do not stop taking your medication suddenly.

Antidepressants are not addictive, but when you stop them or reduce a dose the receptors and levels of chemical transmitters in your brain need to readjust.

Unlike other antidepressants, stopping this medication suddenly is unlikely to cause uncomfortable symptoms, but if you stop taking it too soon, it could increase the risk of you becoming unwell again.

Depending on the dose you are prescribed, your doctor may recommend that you reduce your dose before stopping it completely.

If you do experience uncomfortable symptoms after stopping your medication, talk to your doctor or pharmacist.

Warnings and safety

If you have taken more than the dose prescribed by your doctor, contact NHS 111 immediately to ask for advice, or ask a family member or friend to do this for you. This is important even if you don’t feel any different.

NHS 111 can give you advice and direct you to the best place to get more help if you need it.

If you have taken too much medication on purpose, or if after taking this you quickly feel unwell, call 999 or get someone to take you to A&E straight away. This includes if you have symptoms such as feeling drowsy or sleepy, feeling or being sick, changes in your heart rate or breathing.

If you need to go to A&E, do not travel alone or drive yourself there. Get your parent, family member or friend to go with you to support you and keep you safe on the way. If someone is not able to drive you there, call for an ambulance. Take your medication with you and tell doctors how much you have taken.

Suicidal thoughts

Depression (and other mental illnesses) can sometimes cause you to have thoughts about hurting yourself or taking your own life. While uncommon, this could also be a side effect of your medicine. These thoughts may happen or get worse in the first few weeks of taking (or stopping) your medication. This can happen to anyone but is more likely to happen if you are under 25 years old.

If you have any thoughts like this, it is important you get urgent help. Contact your doctor immediately for advice and support. This could be your GP or specialist mental health team. If you are able, share how you are feeling with family member or friend as well so they can support you to get help.

If you discussed with your doctor what to do if you get these thoughts and created a safety plan, read this to remind you who to contact for support and what you can do to help you cope.

Read our guide to suicidal feelings

Serious side effects

Agomelatine can cause rare but serious side effects, including allergic reactions.

Stop taking agomelatine and go to a hospital straight away if you get any of the following symptoms:

  • difficulty breathing
  • an allergic reaction or allergy (including symptoms such as swelling of your face, eyelids, lips, tongue or throat so that you cannot swallow or breathe or bad itching of the skin with raised lumps)
  • signs of potential liver injury (dark urine, light-coloured poo, yellowing of the skin and eyes, pain in the upper-right belly, and sudden and unexpected tiredness)
  • you start having seizures or fits for the first time

Get your parent, family member or friend to take you or go with you to support you and keep you safe on the way. If someone is not able to drive you there, call for an ambulance. Take your medication with you.

Contact your doctor immediately but don't stop taking agomelatine, if you get any of the following symptoms:

  • excessive sleepiness
  • stomach pains
  • your behaviour changes because you feel very happy or over-excited
  • yellowing of the skin or whites of the eyes (these may be signs of hepatitis)
  • if seizures or fits that you have had in the past start to happen more often

If you are unable to contact your doctor, call NHS 111 for urgent advice.

Side effects and your health

Side effects are more common when you first start taking agomelatine. Many go away as you continue your medicine. If they don’t get better, or if you are worried by them and they are causing you distress, speak to your doctor or pharmacist about them.

Very common side effects, which affect more than one in ten people, include:

  • headache

Common side effects, which affect up to one in ten people, include:

  • anxiety
  • feeling sick or being sick (nausea and vomiting)
  • stomach pain
  • abnormal dreams
  • insomnia (sleep problems)
  • dizziness
  • drowsiness and fatigue
  • increase in weight
  • change in bowel habits
  • back pain
  • changes in liver enzymes (this is why it is important to ensure you have regular blood tests because you might not have any symptoms)

There are other side effects that you can get when taking this medicine. We have only included the most common ones here.

This list of side effects can look scary. You may not experience any of them, but it’s important to be aware of them so you know what to do if they do happen.

Unless your side effects are very severe or distressing, try to continue taking your medication until you can talk to your doctor. Your doctor can make changes to your medication to help if needed.

An uncommon but important side effect to be aware of includes thoughts of harming yourself or taking your own life. This may be a symptom of your illness, including depression, but may be a side effect of your medication. If you experience these thoughts, contact your doctor to seek immediate support to keep you safe.

Your doctor will make sure you are monitored carefully for these side effects, and you should decide with your doctor what to do if you experience these feelings while taking your medication. It’s a good idea to write these plans down and keep them somewhere safe.

If you are taking agomelatine and have not talked about this with your doctor, go back to them and talk it through. You might want to talk to your parents, family member or friend about it too.

Before starting agomelatine, your doctor will check your liver function. Your liver function will also need to be checked at 3, 6, 12 and 24 weeks after you have started taking agomelatine.

Your liver function is checked by taking a blood test. The blood is then analysed for several substances that are made by the liver. This allows your doctor to check how well your liver is working.

You should also look out for any symptoms that could mean your liver isn’t working as well as it should. Seek urgent advice from your doctor if you get any of the following symptoms:

  • unusual darkening of the urine
  • light coloured stools
  • yellow skin/eyes
  • pain in the upper right belly
  • unusual excessive tiredness (especially if you have any of the other symptoms listed)

This is important because rare but serious side effects of agomelatine include hepatitis, jaundice or liver failure.

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About this information

The information on this page was reviewed by the College of Mental Health Pharmacy in September 2024.

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