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.