Indication:Restless legs syndrome (idiopathic)
In a 12?week randomised controlled trial (RCT) in people with severe restless legs syndrome (RLS), there was a moderate improvement in the score on the International RLS study group severity rating scale with oxycodone/naloxone prolonged release tablets compared with placebo. Adverse effects such as fatigue, constipation and nausea were very common. As with all opioids, there is a risk that people may develop opioid dependence. There are no published studies which compare oxycodone/naloxone with other possible treatments for restless legs syndrome and there is limited long-term efficacy and safety data for its use in this indication.