Agomelatine is sold in Germany under the name Valdoxan and has only been on the market for a few years. It is a melatonin receptor agonist, which is mainly used for mild to severe depression and can also combat chronic sleep disorders within a certain range.
What is agomelatine?
Agomelatine promotes the release of norepinephrine or serotonin and also leads to increased dopamine production. This combats depression on a chemical level. Agomelatine promotes the release of monoamines such as norepinephrine or serotonin and also leads to increased dopamine production. This fights depression on a chemical level, and at the same time has the side effect of a more comfortable night’s sleep in patients suffering from sleep disorders. It is taken orally before bedtime with some water and is available by prescription in Germany.
Pharmacological effect
Agomelatine is from the group of melatonin receptor agonists. It acts directly against a deficiency of serotonin or norepinephrine, both of which are considered monoamines. Clinical depression, which is primarily caused by a deficiency of these two monoamines, is thought to be combated by agomelatine. Agomelatine is used to induce an increased production of those neurotransmitters in the body: it combats the deficiency and also leads to an increased release of dopamine. Serotonin, dopamine, and norepinephrine are released in specific areas of the brain, which is thought to improve the patient’s mood. Furthermore, agomelatine is said to have a sleep-promoting effect, which is why it should always be taken directly before bedtime. In very small doses, it is therefore also prescribed as a sleep aid if other agents widely known to be effective should fail. Since taking agomelatine also affects the liver, the drug should not be taken in cases of known liver dysfunction or disease. Agomelatine should also not be taken during pregnancy or immediately thereafter, as the active ingredients may pass into breast milk. The average daily dose is 25 milligrams, and the maximum dose of 50 milligrams should not be exceeded.
Medical use and application
In Germany, agomelatine is mainly used to treat depression in adults (major depression). Because it is chemically based on a different mode of action than already established drugs, it is often administered to individuals who do not respond to classical treatment. Furthermore, agomelatine is also used for chronic insomnia, but there in lower doses and also only when there are no contraindications with other drugs. Since it is still a very young drug, there are only a few studies on the effect of agomelatine. In one study with a participant number of 5,800 patients, agomelatine performed better than placebo preparations. However, in another three studies, no differences were found when fluoxetine or paroxetine were administered concomitantly. In these studies, agomelatine was used in patients with only mild or moderate depression as well as severe depression. The success rate there was 60 to 70%. At the same time, an improvement in the quality of sleep was observed in all participants of the studies, without any loss of attention during the day. Agomelatine should not be used in seniors with dementia.
Risks and side effects
Agomelatine may have a negative effect on the body’s energy balance, which is characterized by fatigue and persistent sleepiness, among other symptoms. Furthermore, agomelatine may cause insomnia as well as headaches and migraine attacks. Also unlikely are sudden onset of anxiety and dizziness, so refrain from operating heavy machinery after first taking agomelatine. The digestive tract may also be affected by the drug, with complaints of nausea as well as constipation and diarrhea. Elevated liver enzymes as well as back pain and occasional visual disturbances are among the side effects of Agomelatine. Very rare side effects include sudden hepatitis and suicidal behavior or thoughts, which is contrary to the original effect of the drug.Regular functional tests of this organ are recommended when agomelatine is administered, especially due to elevated liver values. It should not be administered if concomitant medications such as fluvoxamine or ciprofloxacin are being taken.
