Rozerem (ramelteon) is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the DEA. With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years.