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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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Sleep quality and morning alertness: (a) percentage of patients with very good, good, fair, bad, and very bad sleep quality at baseline, during treatment, at immediate, and at late withdrawal. (b) Percentage of patients who felt completely alert, alert, fair, tired, and very tired at baseline, during treatment, at immediate, and at late withdrawal.
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Figure 3: Sleep quality and morning alertness: (a) percentage of patients with very good, good, fair, bad, and very bad sleep quality at baseline, during treatment, at immediate, and at late withdrawal. (b) Percentage of patients who felt completely alert, alert, fair, tired, and very tired at baseline, during treatment, at immediate, and at late withdrawal.

Mentions: During treatment, the percentage of patients with good sleep quality rated 1–3 (very good, good, fair) increased from 42 (7.1%) patients at baseline to 462 (77.4%) patients (Fig. 3a). The mean±SD sleep quality rating during treatment improved from 4.2±0.6 at baseline to 2.6±1.1 during treatment. Sleep quality improved during treatment by at least one point from baseline in 486 (81.4%) patients. For 90 (15.1%) patients, there was no change in sleep quality, whereas 17 (2.8%) patients and two (0.3%) patients reported a worsening of sleep quality of one or two points, respectively.


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

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

Sleep quality and morning alertness: (a) percentage of patients with very good, good, fair, bad, and very bad sleep quality at baseline, during treatment, at immediate, and at late withdrawal. (b) Percentage of patients who felt completely alert, alert, fair, tired, and very tired at baseline, during treatment, at immediate, and at late withdrawal.
© Copyright Policy
Related In: Results  -  Collection

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

Figure 3: Sleep quality and morning alertness: (a) percentage of patients with very good, good, fair, bad, and very bad sleep quality at baseline, during treatment, at immediate, and at late withdrawal. (b) Percentage of patients who felt completely alert, alert, fair, tired, and very tired at baseline, during treatment, at immediate, and at late withdrawal.
Mentions: During treatment, the percentage of patients with good sleep quality rated 1–3 (very good, good, fair) increased from 42 (7.1%) patients at baseline to 462 (77.4%) patients (Fig. 3a). The mean±SD sleep quality rating during treatment improved from 4.2±0.6 at baseline to 2.6±1.1 during treatment. Sleep quality improved during treatment by at least one point from baseline in 486 (81.4%) patients. For 90 (15.1%) patients, there was no change in sleep quality, whereas 17 (2.8%) patients and two (0.3%) patients reported a worsening of sleep quality of one or two points, respectively.

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