Clonidine for RLS

Clinical bottom line

Only one study with 10 patients exists for clonidine. Adverse events prevented sufficient dose increase to relieve RLS in most patients.

Reference

ML Wagner et al. Randomized, double-blind, placebo-controlled study of clonidine in restless legs syndrome. Sleep 1996 19: 52-58.

Clinical trial

This was a cross-over trial comparing clonidine and placebo in 10 patients with RLS. It measured subjective outcomes, but was an in-depth sleep study.

Results

Subjective measures were significantly better with clonidine than placebo, and sleep latency was reduced. Adverse events prevented sufficient dose escalation to completely relieve RLS symptoms.

Table 1: Details of trial

Reference	Design	Treatments and Outcomes	Patient details	Efficacy	Adverse Events
Wagner et al. Sleep 1996 19: 52-58	R = 1 DB = 2 WD = 1 QS = 4 Crossover Duration = two weeks each	Treatments 1 Clonidine up to 1mg (mean 0.5 mg) daily (10) 2 Placebo (10) Outcomes sleep measures, PLMS, and subjective measures	Mean age 44 (range 29-61), with average duration of 16 years of RLS	Subjective reports were all significantly in favour of clonidine. Sleep studies showed reduced sleep latency	Adverse events were common with clonidine and rare with placebo. With clonidine adverse events prevented dose increase to relieve symptoms in 7 of 10 patients

Comment

There is insufficient information on which to base any judgement, other than successful use of clonidine for RLS is unlikely in most patients.