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Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin.

Hajak G, Lemme K, Zisapel N - Int Clin Psychopharmacol (2015)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: aDepartment of Psychiatry and Psychotherapy, University of Regensburg, Regensburg bDepartment of Psychiatry, Psychosomatic Medicine and Psychotherapy, Social Foundation Bamberg, Bamberg cLundbeck GmbH, Hamburg, Germany dNeurim Pharmaceuticals Ltd, Tel-Aviv, Israel eDepartment of Neurobiology Faculty of Life Sciences, Tel-Aviv University, Israel.

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 treatment had stopped using them and only 5.6% of naive 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.

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Related in: MedlinePlus

Overall study patients’ disposition. APTS, all-patients-treated set; FAS, full-analysis set; PPS, per-protocol set; SmPC, summary of product characteristics.
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Figure 2: Overall study patients’ disposition. APTS, all-patients-treated set; FAS, full-analysis set; PPS, per-protocol set; SmPC, summary of product characteristics.

Mentions: The study was carried out from July 2008 to April 2009 at 204 sites in Germany. During that period, 653 patients were recruited. As one patient was not treated with PRM, the APTS comprised 652 patients. As 55 patients had no post-treatment data, the FAS comprised 597 patients (Fig. 2).


Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin.

Hajak G, Lemme K, Zisapel N - Int Clin Psychopharmacol (2015)

Overall study patients’ disposition. APTS, all-patients-treated set; FAS, full-analysis set; PPS, per-protocol set; SmPC, summary of product characteristics.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4255979&req=5

Figure 2: Overall study patients’ disposition. APTS, all-patients-treated set; FAS, full-analysis set; PPS, per-protocol set; SmPC, summary of product characteristics.
Mentions: The study was carried out from July 2008 to April 2009 at 204 sites in Germany. During that period, 653 patients were recruited. As one patient was not treated with PRM, the APTS comprised 652 patients. As 55 patients had no post-treatment data, the FAS comprised 597 patients (Fig. 2).

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: aDepartment of Psychiatry and Psychotherapy, University of Regensburg, Regensburg bDepartment of Psychiatry, Psychosomatic Medicine and Psychotherapy, Social Foundation Bamberg, Bamberg cLundbeck GmbH, Hamburg, Germany dNeurim Pharmaceuticals Ltd, Tel-Aviv, Israel eDepartment of Neurobiology Faculty of Life Sciences, Tel-Aviv University, Israel.

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 treatment had stopped using them and only 5.6% of naive 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.

Show MeSH
Related in: MedlinePlus