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Safety and efficacy of melatonin, clonazepam, and trazodone in patients with Parkinson's disease and sleep disorders: a randomized, double-blind trial.

Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
October 1, 2022
Fatemeh Hadi et al. (8 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Extracted Claims (11)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin 3 mg/day
decrease
Pittsburgh Sleep Quality Index (PSQI) scores
PD patients with subjective sleep complaints
-
significant decrease
#1
clonazepam 1 mg/day
decrease
Pittsburgh Sleep Quality Index (PSQI) scores
PD patients with subjective sleep complaints
-
significant decrease
#2
trazodone 50 mg/day
decrease
Pittsburgh Sleep Quality Index (PSQI) scores
PD patients with subjective sleep complaints
-
significant decrease
#3
melatonin intake
decrease
RBD screening questionnaire (RBDSQ) score
PD patients with subjective sleep complaints
-
higher decrease
#4
trazodone intake
decrease
Epworth Sleepiness Scale (ESS) score
PD patients with subjective sleep complaints
-
higher decrease
#5
clonazepam
increase
adverse events
PD patients with subjective sleep complaints
three patients
mild adverse events were reported
#6
trazodone
increase
adverse events
PD patients with subjective sleep complaints
two patients
mild adverse events were reported
#7
melatonin
no change
adverse events
PD patients with subjective sleep complaints
-
none
#8
trazodone 50 mg/day
increase
sleep quality
patients with PD
-
tolerable and effective in improving
#9
clonazepam 1 mg/day
increase
sleep quality
patients with PD
-
tolerable and effective in improving
#10
melatonin 3 mg/day
increase
sleep quality
patients with PD
-
tolerable and effective in improving
#11
Abstract

BACKGROUND: Sleep disturbances are common non-motor symptoms of Parkinson's disease (PD). We aimed to compare the safety and efficacy of trazodone with melatonin and clonazepam in patients with PD and sleep complaints. METHODS: This single-center, double-blind, randomized clinical trial was conducted on PD patients with subjective sleep complaints. Eligible patients were randomized 1:1:1 to receive melatonin 3 mg/day, clonazepam 1 mg/day, or trazodone 50 mg/day for 4 weeks. The primary outcome measure was the changes in Pittsburgh Sleep Quality Index (PSQI) scores. The mean change in Epworth Sleepiness Scale (ESS) and RBD screening questionnaire (RBDSQ) was considered as the secondary outcome measures. RESULTS: A total of 112 eligible patients were randomized and 93 participants, melatonin (n = 31), trazodone (n = 31), and clonazepam (n = 31), completed the study. There was a significant decrease in PSQI scores after 4 weeks of treatment in all groups. The mean changes of PSQI from baseline were similar among the treatment arms (P = 0.325). Mean changes of RBDSQ and ESS from baseline were significantly different between study arms (P < 0.05). Melatonin intake was associated with a higher decrease in RBDSQ score compared to trazodone (P = 0.011) and clonazepam (P = 0.004). Trazodone intake was associated with a higher decrease in ESS score compared to clonazepam (P = 0.010). Mild adverse events were reported in three patients in the clonazepam, two patients in the trazodone group, and none in the melatonin group. CONCLUSIONS: Trazodone 50 mg/day, clonazepam 1 mg/day, and melatonin 3 mg/day were all tolerable and effective in improving sleep quality in patients with PD. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (registration number; IRCT20170821035819N2).

Medical Subject Headings (MeSH)
ClonazepamDouble-Blind MethodHumansIranMelatoninParkinson DiseaseSleep Wake DisordersTrazodone
Study Links
Citation Metrics
Total Citations21
Citations/Year7.0
Relative Citation Ratio3.35
NIH Percentile87.2%
Research Impact Scores
APT Score0.75
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