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Objective and subjective sleep quality: Melatonin versus placebo add-on treatment in patients with schizophrenia or bipolar disorder withdrawing from long-term benzodiazepine use.

Psychiatry research
January 1, 1970
Lone Baandrup et al. (3 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether prolonged-release melatonin improved sleep quality during benzodiazepine discontinuation in patients with severe mental illness and whether sleep variables were associated with withdrawal.

Results Summary

Melatonin significantly improved self-reported sleep quality but had no effect on objective sleep efficiency. Reduced benzodiazepine dosage was associated with decreased stage 2 sleep, and discontinuation did not cause rebound insomnia.

Population

Adults with schizophrenia, schizoaffective disorder, or bipolar disorder on long-term benzodiazepines and antipsychotics.

Effective Dosage

Not specified

Duration

24 weeks

Interactions

None mentioned

Extracted Claims (3)
InterventionDirectionEndpointPopulationDosageImpactClaim #
prolonged-release melatonin
no change
objective sleep efficiency
patients with schizophrenia, schizoaffective disorder, or bipolar disorder and long-term use of benzodiazepines in combination with antipsychotics
no significant change
had no effect on
#1
prolonged-release melatonin
increase
self-reported sleep quality
patients with schizophrenia, schizoaffective disorder, or bipolar disorder and long-term use of benzodiazepines in combination with antipsychotics
-
significantly improved
#2
benzodiazepine dosage reduction
decrease
stage 2 sleep
patients with schizophrenia, schizoaffective disorder, or bipolar disorder and long-term use of benzodiazepines in combination with antipsychotics
-
was associated with a significantly decreased proportion of
#3
Abstract

Benzodiazepines are frequently long-term prescribed for the treatment of patients with severe mental illness. This prescribing practice is problematic because of well-described side effects including risk of dependence. We examined the efficacy of prolonged-release melatonin on objective and subjective sleep quality during benzodiazepine discontinuation and whether sleep variables were associated with benzodiazepine withdrawal. Eligible patients included adults with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder and long-term use of benzodiazepines in combination with antipsychotics. All participants gradually tapered the use of benzodiazepines after randomization to add-on treatment with melatonin versus placebo. Here we report a subsample of 23 patients undergoing sleep recordings (one-night polysomnography) and 55 patients participating in subjective sleep quality ratings. Melatonin had no effect on objective sleep efficiency, but significantly improved self-reported sleep quality. Reduced benzodiazepine dosage at the 24-week follow-up was associated with a significantly decreased proportion of stage 2 sleep. These results indicate that prolonged-release melatonin has some efficacy for self-reported sleep quality after gradual benzodiazepine dose reduction, and that benzodiazepine discontinuation is not associated with rebound insomnia in medicated patients with severe mental illness. However, these findings were limited by a small sample size and a low retention rate.

Medical Subject Headings (MeSH)
AdultAntipsychotic AgentsBenzodiazepinesBipolar DisorderCentral Nervous System DepressantsDouble-Blind MethodFemaleHumansMaleMelatoninMiddle AgedPolysomnographyPsychotic DisordersSchizophreniaSleepSleep Initiation and Maintenance DisordersSubstance Withdrawal SyndromeWithholding Treatment
Study Links
Quality Scores
SafetyNot Assessed
Efficacy65/10
Quality70/10
Citation Metrics
Total Citations20
Citations/Year2.2
Relative Citation Ratio1.08
NIH Percentile53.2%
Research Impact Scores
APT Score0.75
Weight Score1.61
Normalized Score0.60
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