What are the risks connected to Circadin® administration?

It is important to understand that adverse events are reported regardless of any perceived relationship to drug treatment. In the overall clinical development program, which included long term open-label studies, patients were treated for longer periods with Circadin^® than with placebo. Due to this fact, adverse event rates have been measured in patient weeks to allow for a direct comparison between Circadin^® and placebo. As measured by the rate of patients with adverse events per 100 patient weeks in clinical trials, the adverse event rate was lower in patients treated with Circadin^® than those receiving placebo (3.17 for Circadin^® versus 8.21 for placebo)¹. The most commonly observed adverse events were headache, pharyngitis, back pain, and asthenia, listed as common by MedDRA definition (i.e., with a frequency of =1/100 to < 1/10)¹, In both the Circadin^® and placebo-treated groups¹². It is very rare that active treatment demonstrates a lower rate of adverse events than placebo, but may be explained by the fact that untreated insomnia (placebo group) is associated with many ‘adverse events’.