What is agomelatine used for?

Agomelatine is an antidepressant medicine used in many countries to treat depression in adults, and in some places it is also used for generalized anxiety disorder (GAD). It is not approved for use in the United States, so doctors in the U.S. cannot prescribe it.

What is agomelatine?

Agomelatine is a medicine used mainly to treat major depressive episodes in adults. In a few countries, it is also approved to treat long‑lasting anxiety called generalized anxiety disorder in adults. It comes as a 25 mg tablet that is usually taken once a day at bedtime.

In many parts of the world it is sold under brand names such as Valdoxan, Thymanax, and others, but no brand is approved in the U.S. If you live in the United States, any agomelatine you see online is not approved by the FDA.

How does agomelatine work?

Agomelatine is classified as an antidepressant. It works by stimulating the melatonin (MT1 and MT2) receptors and by blocking the serotonin (5-HT2c) receptors in the brain. This may lead to higher levels of dopamine and noradrenaline, which help regulate mood and may relieve the symptoms of depression.

What symptoms of depression can it help?

Depression is more than just feeling sad. Common symptoms that agomelatine may help improve include:

• sadness
• feelings of worthlessness
• loss of interest in social activities
• tearfulness
• sleep disturbances
• lethargy
• anxiety
• changes in weight
• suicidal thoughts or actions.

If you ever have thoughts about harming yourself or ending your life, contact emergency services or a crisis hotline right away. Do not wait to see if your medication starts to work.

How well does agomelatine work?

In short-term clinical trials, its effectiveness for depression was superior to placebo and similar to other antidepressants. One study, people felt better after one week of starting the medication. However, in longer-term studies up to one year, the medicine was not effective. It has a strong effect on circadian sleep phase disturbances, improving time to sleep onset and quality of sleep.

Side effects of agomelatine

Like all medicines, agomelatine can cause side effects. Not everyone gets them.

Common side effects may include:

• Headache
• Nausea or upset stomach
• Dizziness
• Sleepiness or, less often, trouble sleeping
• Tiredness

Agomelatine may cause liver toxicity, so your healthcare provider will need to check your liver function tests frequently. If you have liver disease, you may not be able to use this medicine.

A review from Health Canada showed that it produced improvements in sleep disturbances, better tolerability in terms of sexual side effects (vs. SSRIs), and a lack of withdrawal symptoms after abrupt discontinuation of treatment.

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Brand names and foreign names

Foreign names for agomelatine may include:

• agomelatinum (Latin)
• agomelatin (German)
• agomélatine (French)
• agomelatina (Spanish)

Foreign brand name products for agomelatine include:

• Agoprex (India)
• Alodil (Chile)
• Inspago (Egypt)
• Melitor (Serbia, Georgia)
• Thymanax (Spain; Estonia; Lithuania; Sweden; Netherlands; Croatia)
• Valdoxan (Russian Federation; Chile; China; France; Romania; Slovenia; Cyprus; Argentina; Australia; Brazil; Czech Republic; Denmark; Estonia; Egypt; Finland; Hong Kong; Indonesia; Ireland; Iceland; South Korea; Lithuania; Latvia; Malaysia; Poland; Portugal; Sweden; Slovakia; Thailand; Turkey; Uruguay; Belgium; Greece; United Kingdom; Oman; Netherlands; Croatia)
• Valdoxan 25 (Spain; Austria; Switzerland; Germany; Hungary; Luxembourg)
• Valdoxane (South Africa)
• Vestin (Argentina)

Products may not always be reliable, safe or available in every foreign country listed. Some products may have been discontinued by foreign manufacturers, and this list may be incomplete. Use extreme caution if you are purchasing any medicine over the Internet, either domestic or international.

This is not all the information you need to know about agomelatine for safe and effective use and does not take the place of your doctor’s directions. Review the full product information from the country of origin and discuss its use with your health care provider before you take it. This information should not be used to decide whether or not to take this product.

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