Gabapentin Effective in Restless Legs Syndrome

Laurie Barclay, MD

November 22, 2002

Nov. 25, 2002 — Gabapentin was effective for restless leg syndrome (RLS), according to the results of a double-blind crossover study published in the Nov. 26 issue of Neurology. Longer studies will be needed to confirm long-term tolerability of this drug.

"Gabapentin may be a potent agent for treatment of even severe RLS, without the disadvantages of long-term complications of previously favored treatments," study author Diego Garcia-Borreguero, MD, from the Fundacion Jimenez Díaz in Madrid, Spain, says in a news release.

Study subjects were 24 patients with RLS, eight men and 16 women, none of whom had been treated previously with either gabapentin or dopaminergic medications. All other medications were discontinued at least two weeks before study entry. In a crossover design, patients received either gabapentin or placebo in the first of two six-week intervals, with a one-week washout period between alternating treatments.

Gabapentin reduced RLS symptoms compared with placebo, based on an RLS severity rating scale, a sleep questionnaire, and patients' own perception of clinical symptom change. Sleep studies showed a marked reduction in periodic leg movements during sleep, increased total sleep time and slow wave sleep, improved sleep efficiency, and decreased stage I sleep during gabapentin treatment.

Gabapentin treatment was most effective in patients whose symptoms included pain. The mean effective dosage at week 6 was 1,855 mg, but therapeutic effects were already evident at week 4, when mean dosage was 1,391 mg.

"Our study shows dramatic therapeutic effects of gabapentin in RLS under controlled conditions," says Dr. Garcia-Borreguero. "Additional long-term studies are warranted to confirm our outcomes and examine gabapentin tolerance during chronic treatment."

Pfizer S.A., Spain, supported this study and employs or has financial arrangements with some of its authors.

Neurology. 2002;59:1573-1579

Reviewed by Gary D. Vogin, MD


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