Last week the U.S. Food and Drug Administration announced the approval of Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate to severe restless legs syndrome (RLS). The effectiveness of Horizant was studied in two 12-week clinical trials in adults. The drug may cause drowsiness and dizziness and can impair a person’s ability to drive or operate complex machinery. Horizant is the third drug approved by the FDA for the treatment of moderate to severe RLS, joining Requip (ropinirole) and Mirapex (pramipexole).
FDA Approves Horizant to Treat Restless Legs Syndrome
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