Circadin Safety

Circadin.com May 22, 2018
Circadin® is well tolerated and offers a safe treatment as evidenced by the low rate of adverse events in clinical trials 4 5 .

Negative effects of classical sleep drugs such as Zolpidem, Zopiclone and Benzodiazepines, as listed below, do not occur with Circadin® 1  6 7 :

  • 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 8 .
Circadin® also keeps the memory as sharp as with placebo, in contrast to other hypnotics as mentioned above, which impair the memory after dosing 9 .

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 10 4 5

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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