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BACKGROUND: Clinical data show that poor quality, rather than quantity, of sleep corresponds negatively to measures of health, well-being and satisfaction with life. However, until now treatment of insomnia has primarily targeted quantity of sleep. PR (prolonged release)-melatonin offers a new treatment option in insomnia. OBJECTIVES: To provide an overview of PR-melatonin, the first melatonin receptor agonist to be granted marketing authorisation in Europe as monotherapy for the treatment of primary insomnia in patients aged > 55 years. METHODS: Review data published in peer review journals and the EMEA (European Medicines Agency) website. RESULTS/CONCLUSION: PR-melatonin significantly improves morning alertness and quality of sleep compared with placebo. There are no safety concerns.
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