EC Approves 3-Month Treatment Period for Melatonin Sleep Product

Yael Waknine

July 08, 2010

July 8, 2010 — The European Commission (EC) has approved a change in treatment duration from 3 to 13 weeks for a prolonged-release melatonin product (Circadin; Neurim Pharmaceuticals) used to combat primary insomnia in patients aged 55 years and older.

Prolonged-release melatonin is the first sleep agent to be approved for up to 3 months' use.

The action was supported by data from a large phase 4 placebo-controlled clinical study of more than 600 patients showing that the treatment benefits observed at 3 weeks were maintained for at least 3 months.

Patients experienced consistent improvements in sleep latency, quality of sleep, and morning alertness with no incidence of withdrawal or rebound insomnia. This favorable safety profile was maintained for more than 400 patients who received treatment for the entire 6-month study period.

"With Circadin there are no safety concerns and no concerns regarding withdrawal or rebound effects," said Tali Nir, MD, Neurim vice president of clinical and regulatory affairs, in a company news release, noting that some hypnotic drugs cannot be used for longer than 2 to 4 weeks because of safety concerns and potential dependence issues.

The product is the first and only IP-protected prolonged-release melatonin product to be approved as an ethical drug by health authorities, including the Australian Therapeutic Goods Administration, the Swiss Agency for Therapeutic Products, and the Israeli Ministry of Health.

According to company information, the product mimics the natural melatonin profile by releasing melatonin gradually during an 8- to 10-hour period, thereby resetting circadian rhythms and encouraging natural, restorative sleep that improves quality of life.

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