Indications
Agomelatine is a prescription antidepressant used to treat major depression (depressive episodes) in adults. It may also help improve sleep patterns that are disturbed by depression.
How It Works
Agomelatine acts on melatonin receptors (MT1 and MT2), which help set the body clock, and blocks a serotonin receptor called 5-HT2C. Together these actions help reset disturbed sleep and daily rhythms and increase the release of noradrenaline and dopamine in the front part of the brain, which lifts mood. It usually takes about two weeks before benefits start to be felt.
Dosage and Administration
The usual starting dose for adults is 25 mg once daily, taken by mouth at bedtime, with or without food. If there is not enough improvement after two weeks, the doctor may increase it to 50 mg once daily at bedtime, as prescribed. Treatment usually continues for at least six months. Do not stop or change the dose without your doctor’s advice.
Interactions
- Fluvoxamine and Ciprofloxacin strongly raise Agomelatine levels: do not take them together.
- Other medicines such as Propranolol, Enoxacin or oestrogen-containing medicines may raise its levels; Rifampicin and smoking may lower them.
- Alcohol should be avoided because of the risk to the liver.
- Tell your doctor about all medicines that can affect the liver.
Contraindications
- Liver disease, including cirrhosis or active liver disease, or liver enzymes (transaminases) more than three times the upper normal limit.
- Taking Fluvoxamine or Ciprofloxacin.
- Allergy to Agomelatine or any ingredient of the tablet.
- Rare inherited problems with galactose (lactose) where the tablet contains lactose.
Side Effects
Common side effects include headache, dizziness, sleepiness or difficulty sleeping, unusual dreams, anxiety, nausea, diarrhoea or constipation, stomach pain, back pain, tiredness, weight gain and raised liver enzymes on blood tests.
Get urgent medical help if you have thoughts of harming yourself or suicide, yellowing of the skin or eyes, dark urine, pale stools, pain in the upper right abdomen or unexplained tiredness (possible liver injury), or swelling of the face or throat with difficulty breathing.
Pregnancy and Lactation
There is limited information on use in pregnancy, and it is best avoided unless the doctor advises it. It is not known whether it passes into breast milk; discuss with your doctor whether to stop breastfeeding or the medicine.
Precautions and Warnings
- Liver blood tests are needed before starting, and then regularly during treatment (for example around 3, 6, 12 and 24 weeks) and after a dose increase.
- Depression itself carries a risk of suicidal thoughts, especially early in treatment; family members should watch for worsening mood.
- Use with caution in people over 75 years, with a history of mania or bipolar disorder, or who drink alcohol.
- It may cause dizziness or sleepiness; do not drive until you know how it affects you.
- Not for children and adolescents under 18 years.
Overdose
Overdose may cause drowsiness, tiredness, stomach pain, dizziness, anxiety or restlessness. Seek medical help immediately if more than the prescribed amount has been taken.
Therapeutic Class
Antidepressant (melatonin receptor agonist and 5-HT2C antagonist)
Storage
Store below 30°C in a dry place, away from light and out of the reach of children.
Prepared by the Oshud Alo team from standard drug references. For information only; always follow your doctor's advice.