Document Detail

Randomized, double-blind, placebo-controlled study of clonidine in restless legs syndrome.
MedLine Citation:
PMID:  8650464     Owner:  NLM     Status:  MEDLINE    
Ten patients with idiopathic restless leg syndrome (RLS) were asked to rate their symptoms at baseline during 2 weeks of placebo and 2 weeks of clonidine treatment by using a four-point scale. On two consecutive nights each treatment period, polysomnography (PSG) and actigraphic studies were performed. Patients subjectively reported improvement in leg sensations (p = 0.02) and motor restlessness (p = 0.001) while receiving clonidine (mean = 0.05 mg/day). On PSG testing, sleep onset occurred faster with clonidine (12 minutes) compared with placebo (30 minutes) and baseline (47 minutes) (p = 0.006). Adverse findings associated with clonidine treatment included decreased percent REM sleep in the clonidine group (4%) compared with placebo (16%) and baseline (16%) (p = 0.001) and increased REM latency in the clonidine group (195 minutes) compared to the placebo (70 minutes) and baseline groups (89 minutes) (p = 0.028). There were no significant changes in total sleep time, stage 1 and 2 sleep, sleep efficiency, awakenings, arousals or periodic limb movements in sleep. There was a nonstatistical trend toward and increase in stage 3 and 4 sleep and a decrease in motor activity as measured by actigraphic recordings. Globally, seven out of 10 patients felt clonidine was more effective than placebo. Four patients chose to continue clonidine after the study. Clonidine may be an effective treatment for RLS patients who don't have large numbers of sleep-disrupting periodic limb movements but have delayed sleep onset due to leg sensations and subsequent motor restlessness.
M L Wagner; A S Walters; R G Coleman; W A Hening; K Grasing; S Chokroverty
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  Sleep     Volume:  19     ISSN:  0161-8105     ISO Abbreviation:  Sleep     Publication Date:  1996 Jan 
Date Detail:
Created Date:  1996-07-23     Completed Date:  1996-07-23     Revised Date:  2009-01-29    
Medline Journal Info:
Nlm Unique ID:  7809084     Medline TA:  Sleep     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  52-8     Citation Subset:  IM    
Rutgers-State University of New Jersey, College of Pharmacy, Department of Pharmacy Practice and Administration, Piscataway 08855-0789, USA.
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MeSH Terms
Adrenergic Agonists / therapeutic use*
Age of Onset
Clonidine / blood,  therapeutic use*
Double-Blind Method
Middle Aged
Restless Legs Syndrome / complications,  drug therapy*
Sleep Disorders / complications,  diagnosis
Sleep Stages
Sleep, REM
Reg. No./Substance:
0/Adrenergic Agonists; 0/Placebos; 4205-90-7/Clonidine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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