Other Brands/Names

Valdoxan.

How It Works

Agomelatine is an antidepressant that works by promoting earlier sleep onset, reducing body temperature, and stimulating melatonin. Melatonin is a hormone essential for regulating the sleep-wake cycle. These combined effects help ease symptoms of depression.

Indications

Agomelatine is an antidepressant used to treat major depressive episodes in adult patients. This mental condition in adult patients can only be diagnosed by a psychiatrist. The treatment with this medicine should be started only after psychiatric consultation. Self-diagnosis is strongly discouraged.

Contraindications

• Patients with dementia (a decline in brain function such as memory, thinking ability, and comprehension or cognitive function)

• Elderly patients over 75 years old

• Patients with liver disease (such as cirrhosis) or with liver enzyme (serum transaminase) levels greater than 3 times the upper normal limit

Side Effects

Agomelatine can cause several serious side effects, including suicidal thoughts or behavior, increased liver enzyme levels, hepatitis, or jaundice. In rare cases, it can lead to fatal liver failure.

Other possible side effects, grouped by organ system, include:

• Nervous system: headache, migraine, insomnia, anxiety, changes in mental status or alertness, nightmares, hallucinations, restlessness, fatigue

• Digestive system: nausea, abdominal pain, dry mouth, diarrhea, constipation, vomiting

• Respiratory system: sore throat

• Muscles and bones: back pain

• Eyes: blurred vision

• Skin: rash, itching, hives, excessive sweating (hyperhidrosis)

• Immune system: flu-like symptoms

Types

In Indonesia, agomelatine is available as film-coated tablets containing 25 mg of agomelatine.

Dosage

Adults: 25 mg once daily at bedtime. The dose may be increased to 50 mg after 2 weeks if needed (under medical supervision).

Safety

Agomelatine should be used with caution in patients with the following conditions:

• Other psychiatric disorders such as bipolar disorder, mania, or hypomania

• History of diabetes, non-alcoholic fatty liver disease, or elevated liver enzymes before treatment

• History of suicidal behavior or significant suicidal thoughts

• Obesity, alcohol dependence, or smoking habit

• Moderate to severe kidney impairment

Drug Interactions

• Agomelatine’s effects may increase if taken together with estrogens, enoxacin, or propranolol.

• Drug absorption may decrease when used with rifampin.

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