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A critical review of the pharmacological treatment of REM sleep behavior disorder in adults: time for more and larger randomized placebo-controlled trials.

Journal of neurology
January 1, 2022
Moran Gilat et al. (5 authors)
Journal ArticleReviewHuman Study
Study Details

Study Goal

The researchers aimed to critically review the clinical and scientific evidence on the pharmacological management of RBD, focusing on melatonin's effectiveness in patients aged over 50.

Results Summary

The study found that 32.9% of 137 RBD patients reported improvements from melatonin treatment, but three small randomized placebo-controlled trials did not find melatonin superior to placebo.

Population

People aged over 50 with Rapid Eye Movement sleep behavior disorder (RBD).

Effective Dosage

Not specified

Duration

Not specified

Interactions

None mentioned

Extracted Claims (4)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Clonazepam
decrease
Rapid Eye Movement sleep behavior disorder (RBD)
RBD patients
66.7%
reported improvements
#1
Melatonin
decrease
Rapid Eye Movement sleep behavior disorder (RBD)
RBD patients
32.9%
reported improvements
#2
Clonazepam
no change
Rapid Eye Movement sleep behavior disorder (RBD)
-
-
did not find to be superior to placebo
#3
Melatonin
no change
Rapid Eye Movement sleep behavior disorder (RBD)
-
-
did not find to be superior to placebo
#4
Abstract

Rapid Eye Movement sleep behavior disorder (RBD) is a parasomnia causing sufferers to physically act out their dreams. These behaviors can disrupt sleep and sometimes lead to injuries in patients and their bed-partners. Clonazepam and melatonin are the first-line pharmacological treatment options for RBD based on direct uncontrolled clinical observations and very limited double-blind placebo-controlled trials. Given the risk for adverse outcomes, especially in older adults, it is of great importance to assess the existing level of evidence for the use of these treatments. In this update, we therefore critically review the clinical and scientific evidence on the pharmacological management of RBD in people aged over 50. We focus on the first-line treatments, and provide an overview of all other alternative pharmacological agents trialed for RBD we could locate as supplementary materials. By amalgamating all clinical observations, our update shows that 66.7% of 1,026 RBD patients reported improvements from clonazepam and 32.9% of 137 RBD patients reported improvements from melatonin treatment on various outcome measures in published accounts. Recently, however, three relatively small randomized placebo-controlled trials did not find these agents to be superior to placebo. Given clonazepam and melatonin are clinically assumed to majorly modify or eliminate RBD in nearly all patients-there is an urgent need to test whether this magnitude of treatment effect remains intact in larger placebo-controlled trials.

Medical Subject Headings (MeSH)
AgedClonazepamDouble-Blind MethodHumansMelatoninREM Sleep Behavior DisorderRandomized Controlled Trials as TopicSleep Wake Disorders
Study Links
Quality Scores
SafetyNot Assessed
Efficacy33/10
Quality65/10
Citation Metrics
Total Citations36
Citations/Year12.0
Relative Citation Ratio5.93
NIH Percentile94.7%
Research Impact Scores
APT Score0.75
Weight Score2.56
Normalized Score0.46
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