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Agomelatine is a synthetic analogue of melatonin. The manufacturers claim that as well as agonising melatonin, it also antagonises the serotonin 5HT2C receptors.
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Antidepressants with sleep-promoting effects include sedative antidepressants, for example doxepin, mirtazapine, trazodone, trimipramine, and agomelatine which promotes sleep not through a sedative action but through resynchronization of the circadian rhythm.
Agomelatine is a melatonergic antidepressant developed by the pharmaceutical company Servier. It is marketed for the treatment of major depressive disorder and has been reported not to produce discontinuation syndrome or sexual side effects. Agomelatine may also have positive effects on sleep.
Agomelatine is indicated for the treatment of major depressive episodes in adults. Ten placebo controlled trials have been performed to investigate the short term efficacy of agomelatine in major depressive disorder.
Our bodies have a number of important physical and behavioural processes which are controlled by the cycling of day and night. These are called circadian rhythms and, if disrupted, may result in depression. Agomelatine works by helping to restore the balance of these biological rhythms.
Agomelatine has been marketed in Europe since 2009 and Australia since 2010. It was, at one point, on track to being available in the United States.
Novartis purchased the development and marketing rights for Agomelatine in the United States all the way back in 2006. At the time, it was thought to be huge addition to the drug portfolio of Novartis, potentially driving billions in sales.
Agomelatine has a unique mechanism, which may be part of the reason as to why it was coveted for the United States market. It has been classified as an “atypical antidepressant” and works by affecting both melatonin receptors and serotonin receptors. If it were available in the United States, it would be in a medication class of its own, separated entirely from the crowded market of SSRI and SNRI drugs.
ADULT over 18 years, 25 mg at bedtime, increased if necessary after 2 weeks to 50 mg at bedtime
The recommended dose is 25 mg once daily taken orally at bedtime.
After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime.
Over 3900 patients took agomelatine in the depression trials.
The most common adverse effects were headache (14.1%), nausea (7.7%), dizziness (5.5%), dry mouth (3.5%), diarrhoea (3.1%), somnolence (2.9%), fatigue (2.6%), abdominal pain (2.4%) and insomnia (2.4%).
These were mostly mild to moderate.
There were four deaths out of 3956 patients who took agomelatine and one out of 826 patients who took placebo – these were all due to suicide. There were more suicide attempts with agomelatine than with placebo (0.6% vs 0.4%)