Generics Cleared for Restless Leg

(May 11, 2008) - Some people could soon find it easier, and cheaper to sleep at night. The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe restless legs syndrome. (Read about "Sleep")

Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram.

The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating restless legs syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease. (Read about "Parkinson's Disease") The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.

The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving. Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.