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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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Rebound insomnia: percentage of patients with a deterioration by at least one point from baseline at immediate and late withdrawal in sleep quality or morning alertness. As a comparison, the percentage of patients deteriorating during ongoing treatment is also shown.
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Figure 4: Rebound insomnia: percentage of patients with a deterioration by at least one point from baseline at immediate and late withdrawal in sleep quality or morning alertness. As a comparison, the percentage of patients deteriorating during ongoing treatment is also shown.

Mentions: Rebound insomnia, predefined as a deterioration in sleep quality by at least one point from baseline, was evident for 19 (3.2%, 95% CI 1.9–4.9) patients at early and for 12 (2.0%, 95% CI 1.0–3.5) patients at late withdrawal. This figure should also be put in perspective with the fact that 19 (3.2%, 95% CI 1.9–4.9) patients showed a deterioration in sleep quality of at least one point compared with baseline during treatment (Fig. 4).


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

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

Rebound insomnia: percentage of patients with a deterioration by at least one point from baseline at immediate and late withdrawal in sleep quality or morning alertness. As a comparison, the percentage of patients deteriorating during ongoing treatment is also shown.
© Copyright Policy
Related In: Results  -  Collection

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

Figure 4: Rebound insomnia: percentage of patients with a deterioration by at least one point from baseline at immediate and late withdrawal in sleep quality or morning alertness. As a comparison, the percentage of patients deteriorating during ongoing treatment is also shown.
Mentions: Rebound insomnia, predefined as a deterioration in sleep quality by at least one point from baseline, was evident for 19 (3.2%, 95% CI 1.9–4.9) patients at early and for 12 (2.0%, 95% CI 1.0–3.5) patients at late withdrawal. This figure should also be put in perspective with the fact that 19 (3.2%, 95% CI 1.9–4.9) patients showed a deterioration in sleep quality of at least one point compared with baseline during treatment (Fig. 4).

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