Melatonin Neurim

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.