Circadin (melatonine) 2 mg is approved for treatment of primary insomnia in adults aged 55 years and above.
Patients treated with Circadin have shown 11 % point better response than those treated with placebo in randomised double-blinded clinical trails where the quality of sleep was the primary efficacy objective.
There is not observed any serious adverse effects or addiction after 3 weeks of using Cicadin. No studies describe the efficacy of Circadin compared to an active comparator.
The expenditure of Circadin is relative high when compared to products containing zolpidem, zopiclone and zaleplon.
IRF recommends that Circadin should be used on patients that are experiencing unacceptable adverse effects and/or addiction to products containing zolpidem, zopiclone and zaleplon.
At the moment no reimbursement has been granted to Circadin.
Circadin was marketed on October 8th 2007.