Melatonin Neurim
Authorised
This medicine is authorised for use in the European Union
melatonin
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Melatonin Neurim is a medicine used on its own for the short-term treatment of primary insomnia (poor quality of sleep) in patients aged 55 years or over. ‘Primary’ means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
Melatonin Neurim contains the active substance melatonin.
This medicine is the same as Circadin, which is already authorised in the EU. The company that makes Circadin has agreed that its scientific data can be used for Melatonin Neurim (‘informed consent’).
Melatonin Neurim can only be obtained with a prescription.
It is available as tablets; the recommended dose is one tablet a day, taken one to two hours before bedtime and after food. This dose can be continued for up to 13 weeks.
For more information about using Melatonin Neurim, see the package leaflet or contact your doctor or pharmacist.
The active substance in Melatonin Neurim, melatonin, is a naturally occurring hormone, which is involved in coordinating the body’s sleep cycle. Melatonin levels in the blood normally increase when it gets dark and peak in the middle of the night. Older people may produce less melatonin, leading to the development of insomnia. Melatonin Neurim increases their blood levels of melatonin, helping them to sleep. The active substance in Melatonin Neurim is released slowly over a few hours (prolonged-release tablets) which mimics the natural production of melatonin in the body.
Melatonin Neurim was more effective than placebo (a dummy treatment) at improving quality of sleep and the patients’ ability to function normally on the following day in three main studies involving a total of 681 patients aged over 55 years with primary insomnia. The patients assessed the severity of their symptoms using a standard questionnaire after three weeks of treatment. When the results of all three studies were looked at together, 32% of the patients taking Melatonin Neurim (86 out of 265) reported a significant improvement in symptoms after three weeks, compared with 19% of those taking placebo (51 out of 272).
An additional study showed that Melatonin Neurim was more effective than placebo for at least 13 weeks.
The most common side effects with Melatonin Neurim (which may affect up to 1 in 100 people) include headache, nasopharyngitis (inflammation of the nose and throat), back pain and arthralgia (joint pain). These side effects were also common in those taking placebo.
For the full list of side effects and restrictions of Melatonin Neurim, see the package leaflet.
The European Medicines Agency decided that the benefits of Melatonin Neurim are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Melatonin Neurim have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Melatonin Neurim are continuously monitored. Suspected side effects reported with Melatonin Neurim are carefully evaluated and any necessary action taken to protect patients.
Melatonin Neurim received a marketing authorisation valid throughout the EU on 18 November 2022.
Product information
Latest procedure affecting product information:
IAIN/0002
14/09/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Melatonin Neurim
- Active substance
- melatonin
- International non-proprietary name (INN) or common name
- melatonin
- Therapeutic area (MeSH)
- Sleep Initiation and Maintenance Disorders
- Anatomical therapeutic chemical (ATC) code
- N05CH01
Pharmacotherapeutic group
PsycholepticsTherapeutic indication
Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
News on Melatonin Neurim
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