Skip to content
My WebMD Sign In, Sign Up

Restless Legs Syndrome Center

Font Size

FDA OKs First Device for Restless Legs Syndrome

By Susan Jeffrey
Medscape Medical News

June 2, 2014 -- The FDA has approved the first device to improve sleep in patients with restless legs syndrome (RLS).

The device, a pad called Relaxis, was approved Friday. The patient lies in bed and places his or her legs on the pad, which provides vibrations that gradually ramp down and stop. The approval is based on two studies that showed the device was better than a placebo pad for improving sleep in patients with RLS, the company, Sensory Medical Inc., says in a statement.

The device is an alternative for patients who now are treated either by getting up to move their legs to relieve symptoms (which interrupts sleep) or using medications including anticonvulsants, opioids, muscle relaxants, or sleep medications, the company says.

The company's web site notes that the pad may also make RLS symptoms worse, which get better within 3 weeks of stopping use of the device. Other side effects include leg cramping, soreness, pain, and motion sickness.

The new device will be available on a prescription-only basis in the U.S. later this year, the company says.

Today on WebMD

woman stretching leg
ARTICLE
doctor talking to patient
ARTICLE
 
unhappy couple in bed
ARTICLE
woman sleeping in front of computer
TOOL
 
woman asleep foot hanging out
ARTICLE
pharmacist with a client
ARTICLE
 
woman walking her dog
ARTICLE
patient and doctor
ARTICLE