FDA approves drug for restless legs syndrome

April 14, 2011

The United States Food and Drug Administration has approved gabapentin enacarbil (Horizant) extended-release tablets as a once-daily treatment for moderate to severe restless legs syndrome (RLS).

The United States Food and Drug Administration has approved gabapentin enacarbil (Horizant) extended-release tablets as a once-daily treatment for moderate to severe restless legs syndrome (RLS).

Two 12-week clinical trials in adults showed improvement in RLS symptoms in patients taking gabapentin enacarbil compared with placebo. The drug may cause drowsiness and dizziness and can impair the ability to drive or operate complex machinery. It will carry a warning about possible suicidal thoughts and actions similar to the warnings on epilepsy drugs because when gabapentin enacarbil is metabolized it becomes gabapentin, which is used to treat epileptic seizures.