Circadin Safety May 24, 2016

Circadin® is well tolerated and offers a safe treatment as evidenced by the low rate of adverse events in clinical trials.

Negative effects of classical sleep drugs such as Zolpidem, Zopiclone and Benzodiazepines, as listed below, do not occur with Circadin® 1:

  • Altered sleep architecture
  • Residual daytime sedation
  • Cognitive and psychomotor impairment
  • Memory impairment
  • Rebound insomnia
  • Withdrawal
  • Development of tolerance
  • Physical dependence
  • Postural instability

On the contrary, Circadin® demonstrated improvement in daytime functioning and according to studies is not associated with impairment of psychomotor function and driving skills3. Nevertheless, Circadin® may cause drowsiness and therefore should be used with caution.
Circadin® also keeps the memory as sharp as with placebo, in contrast to other hypnotics as mentioned above, which impair the memory after dosing.

Memory and Driving Performance3

Circadin® is safe to use for treating insomnia, based on thousands of patients participating in Circadin® clinical trials who had very low rates of adverse events, none of which were severe.

Circadin® contains melatonin which is a naturally occurring hormone and it is safe to use in many medical conditions where traditional hypnotics are contra-indicated (should not be used)2.

Long term safety

In a long term study2 in adults (age 18-80 years) with primary insomnia, Circadin® was safe and well tolerated throughout the 6 months study period. Adverse events were not different from placebo and there were no withdrawal symptoms or rebound insomnia upon discontinuation. In another study in adults (aged 20-80 years), Circadin® was given for 6 and 12 months and had a good safety and tolerability profile with no withdrawal and rebound phenomena upon discontinuation after long term treatment.

Study results confirmed good safety and tolerability profile of Circadin® over a period of at least 6 months uninterrupted treatment.

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