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• Click "Print this page" on the left to print the whole section
• Download a PILL (Patient Information Leaflet), a two-page summary of the main questions and answers from here for agomelatine. This can then be printed.
• Download a BILL (Basic Information Leaflet), a one-page larger print basic summary of the really main questions and answers from here for agomelatine. This can then be printed.

There are many other Patient Information Leaflets (PILs) across the world for patients and carers. There are also official information leaflets (often called a Data Sheet, Package Insert, or Summary of Product Characteristics). They are not on our site, so we can't take any responsibility for them but you can click here for links to other sites and leaflets

^{Updated 2.12}

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Agomelatine is used for depression. It may have some use for bipolar depression. All antidepressants seem to be roughly equally effective at the proper dose but have different side effects to each other. If one medicine does not suit you, it may be possible to try another.

^{Updated 10.11}

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The starting dose is 25mg once a day at bedtime. If that doesn't help, the dose can be increased after 2 weeks to 50mg once a day at bedtime. It can be used in the elderly, just with a little more caution.

It is not recommended for use in the under 18s, although it is not thought to be dangerous as such, just that there aren't any studies in younger people.

^{Updated 10.11}

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The answer to this question usually depends on what you are taking a medicine for. Click on the link below for the main options (self-help and help from others), the main medicines, and a handy chart comparing the main medicines for depression:

• Depression - main options, main medicines and handy chart

There are other treatments for the conditions above. The main ones are included in the section on the condition above.

^{Updated 10.11}

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Agomelatine is unusual in that its main effect is via melatonin. It stimulates melatonin receptors (M1 and M2). This seems to trigger a chain of events (a cascade) which then helps improve your daily Circadian rhythm and improves mood. Agomelatine doesn't just work by improving sleep because if did, then melatonin itself would be a cracking antidepressant, which it isn't. Agomelatine also blocks some serotonin receptors, which may boost noradrenaline and dopamine. 

^2.11

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Agomelatine tablets should be swallowed with at least half a glass of water whilst you are sitting or standing. This is to make sure that they reach the stomach and do not stick in your throat.

^{Updated 10.11}

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Take your agomelatine at night. This should be in the evening or just before you go to bed. It will not work if you take it at any other time. There is no problem about taking agomelatine before, with or after food. If you are a shift-worker, take your agomelatine at bedtime.

^{Updated 10.11}

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For depression, it seems that agomelatine either works or it doesn't. You should usually know within two weeks if it has started to work. If it has not started working in two weeks, you should increase the dose from 25mg (one tablet) at night to 50mg (two tablets) at night. So, you should know within about two to four weeks.

^{Updated 10.11}

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See the section on depression. Generally speaking, it is usually necessary to take agomelatine for at the very least a few months after you have got better. Usually it is best to take them for at least 6 to 12 months to make sure you are fully over your illness.

^{Updated 10.11}

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Agomelatine is not "addictive" as such (e.g. no one abuses it) and there have been no reports of discontinuation or withdrawal symptoms. For a drug to be addictive or produce dependence, then it must have a number of characteristics:

• should produce craving for the drug when the last dose "wears off"

• there should be a "reward" (e.g. a good feeling) from taking the drug

• should produce tolerance ie you need more drug to get the same effect

• should produce withdrawal symptoms specific to that drug.

These characteristics come from the World Health Organisation. Agomelatine has none of these and so is not addictive.

Click here to read a bit more about this, where you can find our thoughts on this knotty problem.

^{Updated 10.11}

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Start again as soon as you remember. If you forget a dose one night, there is no point in taking it next morning so just wait until the next evening. Missing the occasional dose (e.g. once a week) isn't a big problem.

If you have problems remembering your doses (as many people do) ask you pharmacist, doctor or nurse about this. There are some special packs, boxes and devices which can be used to help you remember. You can try leaving the pack somewhere you will see it each morning e.g. in the bathroom, next to bed etc.

^9.10

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There is no problem stopping agomelatine suddenly. However, you should make sure you have taken agomelatine long enough, even if you feel better, because your depression can return if treatment is stopped too early (see "How long will I need to keep taking it for?"). 

^2.11

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The table below shows you some of the side effects you might get from agomelatine. The list is unusually short.

Do not be worried by this list of side effects. Some people get no side effects at all and others may get some effects that are not listed in this table. Side effects tend to be worse with higher doses. Starting with a lower dose sometimes helps. If you think you might have a side effect to your medicine, you should discuss this with your doctor, nurse of pharmacist. You should also see the manufacturer's information leaflet.

^{Updated 12.11}

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Agomelatine can cause slight dizziness but should not make you feel sleepy or drowsy. You should be taking your last dose just before you go to bed so this shouldn't be a big problem. To be on the safe side, you should be careful about driving (see below) or operating machinery until you know how it affects you.

^{Updated 11.11}

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Agomelatine does not cause changes in weight. If you do start to put on weight or have problems with your weight, your doctor can arrange for you to see a dietician for advice. Any weight you put on can be controlled while you are still taking this medication, with expert advice about diet.

Click here for a few tips on how to help you feel less hungry and lose weight.

^5.11

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Drugs can affect desire (libido), arousal (erection) and orgasm. Agomelatine is not thought to affect any of these these three stages. Lack of desire and impotence has been reported very rarely. If this does seem to have happened, you should discuss this with your doctor. Any problem will go away if the agomelatine is stopped. Not only that, but two studies have shown that having depression is more likely to affect your sex-life than an antidepressant ^{(eg Lanza di Scalea 2009)}.

^{Updated 10.11}

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You should have no problems with any foods or drinks with agomelatine.

^6.11

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Whether or not it is safe to drink alcohol with any medicine will depend on:

• How much you have to drink e.g. the amount and over how long
• What you then try to do (e.g. sleep or drive)
• If you have any other conditions e.g. asthma or a chest infection (as alcohol can make it harder to breathe), epilepsy
• If you are taking any other medicines

Alcohol reaches all parts of the brain and can affect many things e.g. thinking, reactions and breathing. Alcohol can also boost the effect of GABA (the brain's main calming chemical messenger).

It is not thought that alcohol will make the side effects of agomelatine worse.  

It is not safe to drive after drinking alcohol, with or without agomelatine. Some countries allow driving after a small amount of alcohol but others have a zero tolerance. The UK has the highest limit in Europe, France lower, Scandanavia even lower and zero in some Eastern European countries. It is not possible to say what blood level you might have from a drink so it is safest not to drink if you know you may have to drive. It is taken as a very serious offence in most countries. You should see National Guidelines, laws and regulations in the country in which you are driving.

^{Updated 11.11}

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Agomelatine has almost no drug interactions:

• The effects of agomelatine can sometimes be increased by fluvoxamine (an unlikely combination)
• The effect of agomelatine can be very slightly decreased by smoking

This does not necessarily mean that this will happen in everyone or that some of these medicines can not be used together. It is just that you may need to follow your doctor's instructions very carefully. There are many other possible drug interactions (e.g. you can try an external on-line drug interactions checker, although this is nothing to do with our site).

^{Updated 1.12}

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Cigarette smoke contains over 3000 different chemicals. Some of these chemicals can make some of the enzymes in the liver work faster (called "enzyme induction" of e.g. CYP1A2 or P4501A2). This means that any medicine those enzymes break down will be broken down quicker. So, you'll end up with less of that medicine if you smoke. And also you will have more of it in the body if you stop smoking.

Agomelatine is one of those medicines. The amount of agomelatine in the body can drop by up to a third (33%) if you smoke, giving less effect or meaning you might need a higher dose to get the same effect. It also means that if you stop smoking, the levels will rise so you might get more side effects. However, agomelatine has so few side effects this is probably not a problem.

^3.11

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By including this section, we're not saying it's right to take illicit or illegal drugs, because it isn't. We're just trying to answer the questions as best we can under the circumstances. With illicit drugs, the full answer is usually that we don't really know. So, we can only go on a few studies, a few reports and what we know about the drugs themselves.

Cannabis (illegal in most countries):

Smoking cannabis increases the amount of dopamine in the pleasure centres of the brain, which is where the reward or buzz comes from. However, psychosis also comes from having too much dopamine in another area of the brain. You have to remember that cannabis can increase dopamine in all areas of the brain and so can make psychosis worse. Please be careful, everything in moderation and if dope makes you worse, keep off the grass. It really won't help you in the long-term. Don't forget that if you're a toker, you're also a smoker, so see the question above. However, there are no extra problems with smoking cannabis with agomelatine, other than the smoking itself (see above).

Cocaine (illegal in most countries)

Cocaine is of course highly addictive and has many adverse or side effects on the body and brain. It can make most mental health symptoms worse in the long-term. However, there are no reports of extra problems with agomelatine and cocaine, although this doesn't mean it's safe.

Ecstasy (illegal in most countries)

Ecstasy has many effects on the brain, the main ones producing the high seem to be by boosting serotonin, noradrenaline and dopamine in the brain. While it can cause a high, the effect wears off fairly quickly. It seems that the toxic effects on the brain are cumulative i.e. the more tablets you have over your lifetime, the more chance you have of having damage to the brain e.g. long-term depression and poor memory. However, there are no reports of extra problems with agomelatine and ecstasy, but again this doesn't mean it's safe.

Opiates

The opiates include many chemicals, some of which are used in medical care (e.g. codeine for diarrhoea and stopping coughs, diamorphine and morphine for pain). However, there are no extra problems reported from taking opiates (e.g. heroin, methadone, codeine) with agomelatine.

^{Updated 1.12}

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You should have no problems with "The Pill" and agomelatine.

^{Updated 10.11}

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In the UK, Levonelle one step® is available and is usually known as 'the morning after pill'. It is taken to reduce the chances of becoming pregnant after unprotected sex or failure of a contraceptive method. In fact "Emergency Contraception" is the better term because it can be taken up to 72 hours (3 days) afterwards. It can be bought over-the-counter without a prescription from pharmacies. EllaOne® tablets (which may work up to 5 days afterwards) and a coil (Intra-uterine device) can also be used but must be prescribed by a Doctor.

If you are taking agomelatine, the usual dose should work if you follow the instructions carefully.

N.B. We accept that for religious, cultural or ethical reasons some people do not approve of, or agree with, the use of the "Morning After" pill. However, we have answered the question because it is one of the most often asked of NHS Direct in UK, and they suggested we include it.

^6.11

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It is important to consider that there will be a risk to you and your child from taking a medicine during pregnancy but also a possible risk from stopping the medicine e.g. getting ill again. Unfortunately, no decision is risk-free. It will be for you to decide which is the least risk. All we can do here is to help you understand some of the issues, so you can make an informed decision. For your information, major malformations occur "spontaneously" in about 2-4% of all pregnancies, even if no drugs are taken. The main problem with medicines is termed "teratogenicity" i.e. a medicine causing a malformation in the unborn child. A medicine causing teratogenicity is called a "teratogen". Since a baby has completed its main development between days 17 and 60 of the pregnancy (the so-called "first trimester") these first 2-16 weeks are the main concern. After that, there may be other problems e.g. some medicines may cause slower growth. The infant may also be affected after birth e.g. withdrawal effects are possible with some drugs.

If possible, the best option is to plan in advance. If you think you could become pregnant, discuss this with your doctor and it may be possible to switch to medicines thought to carry least risk, and take other risk-reducing steps e.g. adjusting doses, taking vitamin supplements etc. If you have just discovered you are pregnant, don't panic, but seek advice from your GP within the next few days if possible. He or she may also want to refer you on to someone with more specialist knowledge of your medicine.

Very few medicines have been shown to be completely safe in pregnancy and so no manufacturer or advisor can ever say any medicine is safe. They will usually advise not to take a medicine during pregnancy, unless the benefit is much greater than the risk. In the UK, there is the NTIS (National Teratology Information Service) who offer individual risk assessments. However, their advice should always be used to help you and your doctor decide what is the risk to you and your baby. There is a risk from taking the medicine and a risk should you stop a medicine e.g. you might become ill again and need to go back on the medication again. The advice offered here is just that i.e. advice, but may give you some idea about the possible risks and what (at the time of writing) is known through the medical press.

It may be helpful to know that in the USA, the FDA (Food and Drug Administration) classifies medicines in pregnancy in five groups:
A = Studies show no risk, so harm to the unborn child appears only a remote possibility
B = Animal and human studies indicate a lack of risk but are not fully conclusive
C = Animal studies indicate a risk but there is no safety data in humans
D = a definite risk exists but the benefit may outweigh the risk in some people
X = the risk outweighs any possible benefit

Agomelatine is not classified yet. You should still seek personal advice from your GP, who may then if necessary seek further specialist advice.

^{Updated 10.11}

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Almost every medicine passes into breast-milk. The main questions are how much and if this is likely to have an effect on your baby. But also remember that being ill (e.g. depressed, manic, psychotic) may have more harmful and lasting effects on you and your child (such as bonding and behaviour e.g. Field, 2010) than a small amount of an effective medicine. If you have been taking a medicine while you are pregnant, you should usually be able to carry on as the amount in breast-milk is much less than the baby would have got while you were pregnant. It is usually thought to be fairly safe if the baby gets less than 10% of the mum's dose. But there may be times when although a medicine gets into breast milk the benefit may be worth the risk, so you should seek personal advice on this.

If you stop any medicine suddenly, some people can get discontinuation or withdrawal symptoms (see question above). If you have been taking a medicine during pregnancy, the same can sometimes happen to the baby when born. If the drug gets into breast milk, this can reduce the effect of suddenly not having the medicine (as well as coping with being in the big wide world too).

If you want to breast-feed there are some things you can do to reduce any risk:

• Nearly all medicines can be taken once a day. So, taking your daily dose just before the baby's longest sleep (often this will be at night) will reduce the amount the baby gets from the milk.

• Any side effects in the baby will be higher if the mum is taking a higher dose. So, try to take the lowest dose possible to still get an effect.

• Try not to take any medicines you don't really need. This includes any medicines you might buy over-the-counter

• Make sure your nurse, health visitor or doctor checks your baby for any side effects e.g. being extra sleepy, having colic, feeding problems, being floppy or poor weight gain. If there are any problems you might need to switch medicines or drop your dose a bit

• Hind milk (the second half of the feed) is likely to contain slightly more of any medicine than the first half

• Avoid new medicines if possible as there is less information about them and breast-feeding.

You must be extra careful of any medicines if your baby was pre-mature, or has kidney, liver, heart or brain problems.

We don't really know about agomelatine, although animal studies show some might get into the milk. It is officially not recommended. However, agomelatine is only in the body for a couple of hours so the risk must be very low.

^6.11

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Several female functions such as menstrual cycle (e.g. your periods) are controlled by a hormone called prolactin. Prolactin in the body rises during and after pregnancy and this triggers the body to make breast milk. The amount of prolactin in the body is kept in control by one part of the brain uses dopamine as its chemical messenger. Some medicines (especially antipsychotics) block the effect of dopamine in the brain.

Luckily agomelatine doesn't seem to have any effect on dopamine in this part of the brain and so should not have any effect on your periods. If your periods are irregular or late, or you start leaking milk, then you should see your doctor about this to find the cause.

^{Updated 11.11}

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Agomelatine should not affect your ability to drive, but it can cause dizziness and lightheadedness so, until you know how agomelatine affects you, be careful about driving or operate machinery.

If you are taking any medicines, the rules about driving will depend on the country you’re driving in. Click on the links below for advice:

• Medicines and driving in the UK (England, Scotland, Northern Ireland and Wales)

• Medicines and driving in the Republic of Ireland

General advice on driving safely

If you want to drive, you should take sensible steps to reduce any risk. These could include:

• Avoid driving when you are tired or ill
• Do not drive after having any alcohol as this can make any drowsiness worse (a third of all fatal road traffic incidents involve alcohol-dependent drivers)
• Avoid driving at night, dusk or in bad weather
• Avoid motorways, dual carriageways and the rush hour
• Give yourself plenty of time. Don’t rush
• Be extra careful if you have not slept well the previous night

As some medicines can affect your driving, be extra careful:

• If starting a new medicine
• After a change in dose (especially an increase)
• If you are on a high dose or seem very sensitive to side effects
• If you are taking any medicines for other symptoms e.g. antihistamines for hay fever or allergies
• If your medicine causes you blurred vision, drowsiness, poor co-ordination, poor attention

If you are driving less than 2000 miles a year, once you consider insurance, tax, MoT, repairs, maintenance, parking and petrol, you may actually find it is cheaper to get taxis and busses, and walk the short journeys.

^{Updated 11.11}

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You will need a blood test when you start agomelatine, after 6 weeks, 12 weeks and 6 months. This is because about 1 in 250 people have a slight rise in LFTs (liver function tests). This is almost certainly not a problem but as agomelatine is new, until it is proven to be safe these tests are needed. 

^{Updated 10.11}

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The European Medicines Agency (EMA) is the body that approves medicines for use in the EU. Their website has a summary of the European Public Assessment Report (EPAR) for agomelatine (Valdoxan®). The EPAR is all the scientific stuff put in a readable way. It explains how and why the Committee for Medicinal Products for Human Use (CHMP) looked at the information on agomelatine and decided to allow it to be marketed ("granting a marketing authorisation" as the call it).  Click here to see their readable report.

^{Updated 7.11}

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