What is Circadin?
Circadin is a medicine that contains the active substance melatonin. It is available as white prolonged-release tablets (2 mg). The term "sustained release" means that melatonin is released slowly from the tablet over a few hours.
What is Circadin used for?
Circadin is indicated as monotherapy (alone) for the short-term treatment of primary insomnia (poor quality sleep) in patients aged 55 years and older. The term "primary" means that insomnia does not have a cause, including environmental causes or other medical or mental conditions.
The medicine can only be obtained with a prescription.
How is Circadin used?
The recommended dose of Circadin is one tablet per day, taken 1-2 hours before bedtime and on a full stomach. This dosage should be maintained for three weeks. Circadin is not recommended in patients who have liver problems and should be used with caution in patients with kidney problems.
How does Circadin work?
The active ingredient in Circadin, melatonin, is a hormone naturally present in the body, usually produced by a gland located in the brain and called the "pineal gland." Melatonin is involved in coordinating the sleep cycle by acting on cells located in specific areas. levels of this substance in the blood normally increase with the onset of darkness and peak in the middle of the night to promote sleep. Older people may produce less melatonin and consequently suffer from insomnia. By replacing the hormone. , Circadin increases blood melatonin levels, promoting sleep. Circadin tablets release melatonin slowly over a few hours, mimicking the body's natural production of melatonin.
How has Circadin been studied?
The effects of Circadin were first tested in experimental models before being studied in humans. The company also presented data from the scientific literature. The effects of Circadin were also looked at in three main studies involving a total of 681
patients over 55 years of age with primary insomnia. The studies compared the effects of Circadin with those of placebo (a dummy treatment). The main measure of effectiveness was the percentage of patients who reported significant improvement in sleep quality and daytime function after three weeks of treatment. Patients rated the severity of their symptoms based on a standard questionnaire.
What benefit has Circadin shown during the studies?
Circadin was more effective than placebo in improving the patient's sleep quality and function throughout the day. Looking at all three studies together, 86 (32.4%) of 265 patients treated with Circadin reported a significant improvement in symptoms compared with 51 (18.7%) of 272 subjects who received placebo.
What is the risk associated with Circadin?
Side effects in patients treated with Circadin are rare, but the most common (reported in 1 to 10 patients in 1000) are irritability, nervousness, restlessness, insomnia, abnormal dreams, migraine, psychomotor hyperactivity (restlessness associated with "increased activity). , dizziness, sleepiness, abdominal pain, constipation, decreased salivation, hyperbilirubinaemia (increased level of bilirubin in the blood, a product of red blood cell metabolism, which can cause yellowing of the skin and eyes), hyperhidrosis (excessive sweating), asthenia (weakness) and weight gain. For the full list of side effects reported with Circadin, see the package leaflet. As Circadin may cause drowsiness, it should be used with caution in people where this effect may pose a safety risk, including those who need to drive or operate machinery. Alcohol consumption should be avoided before, during and after taking Circadin. Circadin should not be used in people who may be hypersensitive (allergic) to melatonin or any of the other substances.
Why has Circadin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that although Circadin has been shown to have a limited effect in quite a small number of patients, its benefits outweigh its risks in the short-term treatment of " Primary insomnia characterized by poor quality sleep in patients aged 55 or older The Committee recommended release
of the marketing authorization for Circadin.
Other information about Circadin:
On 29 June 2007, the European Commission released EEC Limited to Neurim Pharmaceuticals
a "marketing authorization" for Circadin, valid throughout the European Union.
For the complete version of the Circadin EPAR click here.
Last update of this summary: 05-2007
The information on Circadin - melatonin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
