Hajak, Goeran and Lemme, Kathrin and Zisapel, Nava (2015) Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin. INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY, 30 (1). pp. 36-42. ISSN 0268-1315, 1473-5857
Full text not available from this repository. (Request a copy)Abstract
Surveillance studies are useful to evaluate how a new medicinal product performs in everyday treatment and how the patient who takes it feels and functions, thereby determining the benefit/risk ratio of the drug under real-life conditions. Prolonged-release melatonin (PRM; Circadin) was approved in Europe for the management of primary insomnia patients age 55 years or older suffering from poor quality of sleep. With traditional hypnotics (e.g. benzodiazepine-receptor agonists), there are concerns about rebound insomnia and/or withdrawal symptoms. We report data from a postmarketing surveillance study in Germany on the effects of 3 weeks of treatment with PRM on sleep in patients with insomnia during treatment and at early (1-2 days) and late (around 2 weeks) withdrawal. In total, 653 patients (597 evaluable) were recruited at 204 sites (mean age 62.7 years, 68% previously treated with hypnotics, 65% women). With PRM treatment, the mean sleep quality (on a scale of 1-5 on which 1 is very good and 5 is very bad) improved from 4.2 to 2.6 and morning alertness improved from 4.0 to 2.5. The improvements persisted over the post-treatment observation period. Rebound insomnia, defined as a one-point deterioration in sleep quality below baseline values, was found in 3.2% (early withdrawal) and 2.0% (late withdrawal). Most of the patients (77%) who used traditional hypnotics before PRM patients started such drugs after PRM discontinuation. PRM was well tolerated during treatment and the most frequently reported adverse events were nausea (10 patients, 1.5%), dizziness, restlessness and headache (five patients each, < 1%). There were no serious adverse events and no adverse events were reported after discontinuation. The persisting treatment effect and very low rebound rate suggest a beneficial role of sleep-wake cycle stabilization with PRM in the treatment of insomnia. (C) 2014 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | IMPROVES SLEEP QUALITY; CLINICAL-IMPLICATIONS; CIRCADIAN PACEMAKER; PRIMARY INSOMNIA; LONG-TERM; WITHDRAWAL; EFFICACY; SAFETY; AGE; ASSOCIATION; hypnotics; prolonged-release melatonin; rebound insomnia; withdrawal symptoms |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 05 Aug 2019 07:46 |
| Last Modified: | 05 Aug 2019 07:46 |
| URI: | https://pred.uni-regensburg.de/id/eprint/6390 |
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