Lundbeck is celebrating the European launch of Circadin, a new, first-in-class sleep medication which the Danish firm says will offer “hope for thousands of sufferers of insomnia”.

Circadin (sustained-release melatonin) regulates the circadian rhythm (or sleep cycle) and enables a restorative night’s rest, the company said, and it is the first melatonin agent approved by the European Medicines Agency. The approval was based on clinical studies for over 55s which showed that almost half of patients taking the treatment experienced a significant improvement in quality of sleep, and nearly 40% improved on morning alertness.

Lundbeck noted that 70% of patients responding to Circadin on both quality of sleep and morning alertness reported a significant improvement in quality of life but the most attractive thing about the new treatment is that its mode of action avoids side effects associated with traditional sleep drugs. The latter have been associated with adverse reactions such as daytime sedation (or ‘hangover’), plus impaired memory, driving skills and concentration.

Furthermore, Lundbeck said that abrupt withdrawal of benzodiazepine hypnotics is associated with a return of insomnia worse than before and carry a risk of dependency. However Circadin has been shown not to have any risk of rebound insomnia “nor any impairment on memory or psychomotor functioning at any point Adverse effects were generally mild and infrequent and included headache, sore throat, back pain and generalised feelings of weakness.

Circadin was licensed-in from Neurim Pharmaceuticals, and last month, Lundbeck signed an expanded agreement with the Israeli-based firm to market the drug next year in Asia, Latin America and other major markets such as Australia and Turkey.