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Even though articles writen by authorities on Restless Legs Syndrome state that Sinemet CR is the drug of choice for the treatment of this difficult condition, I feel obliged to tell you that Sinemet CR has not been approved by the FDA or any other regulatory agency in the world for this indication. The reason being that there has never been an extensive, adequately controlled clinical trial to demonstrate absolute efficacy for Sinemet CR. Does this mean that doctors will not prescribe Sinemet CR for RLS? No, and many actually do. It also does not mean that physicians are doing anything wrong or unethical by writing such a prescription. When they do, this is an "off label" use of a drug. Such use should be monitored carefully by the prescribing physician. I hope that RLS sufferers do find relief for their bothersome condition which is not just confined to the night time for some individuals. Best regards, Joe Irr : Worldwide Product Manager, Sinemet Brand ([log in to unmask])