Clonazepam for RLS

Clinical bottom line

There is no information on which to justify treating patients with clonazepam.

Reference

P Montagna et al. Clonazepam and vibration in restless legs syndrome. Acta Neurol Scand 1984 69: 428-430.

Clinical trial

This was a tiny crossover trial involving six patients randomised to clonazepam 1 mg daily or placebo for one week. Various outcomes were measured.

Results

Clonazepam was somewhat better than placebo (Table 1).

Table 1: Clinical trial of clonazepam

Reference	Design	Treatments and Outcomes	Patient details	Efficacy	Adverse Events
Montagna et al. Acta Neurol Scand 1984 69: 428-430.	R = 1 DB = 1 WD = 1 QS = 3 Crossover Duration = one week	Treatments 1 clonazepam 1 mg daily (6) 2 placebo (6) Outcomes Quality of sleep and leg movements	Age range 44-64 (Mean 54 years), with RLS for average of 15 years	Clonazepam better than placebo for sleep quality and leg movements. Five of six patients preferred clonazepam to placebo	None noticed

Comment

There was insufficient data about clonazepam in RLS. One further further study identified was not randomised, not double-blind, and 10 patients with RLS, and used a single dose of clonazepam (Saletu et al European Neuropsychopharmacol 2001 11: 153-161.)