The FDA has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets for short-term treatment of insomnia characterized by difficulties with sleep initiation. Orexo is the manufacturer and its partner, Meda, holds the exclusive worldwide commercialization license for Edluar. The drug is expected to launch in the U.S. market during the second half of 2009.
Edluar is a fast-acting, sublingual formulation of zolpidem.