FDA Approves New RLS Drug

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May 16, 2011

The FDA recently approved a new drug to treat restless legs syndrome (RLS). Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment, is the third drug approved by the FDA to treat moderate-to-severe restless legs syndrome (RLS).

RLS is a neurological movement disorder that disrupts sleep. It is characterized by an irresistible urge to move due to tingly or uncomfortable sensations in your legs when you’re lying in bed. Epidemiological studies have shown that RLS affects between 7% and 10% of Americans.

“People with restless legs syndrome can experience considerable distress from their symptoms,” said Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Horizant provides significant help in treating these symptoms.” 

For more information about the drug and its side effects, speak with your healthcare provider or visit the FDA’s website . To learn more about RLS, see “How do I know if I have RLS?” on the National Sleep Foundation’s website .