Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. (“Sunovion”; formerly Sepracor Inc., “Sepracor”; a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.), has been marketed in the United States since April 2005. The agent was approved as the first insomnia treatment not to have restrictions on its length of use, and is widely used by individuals suffering from insomnia. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market it in Japan from Sunovion (at the time known as Sepracor) in July 2007. The company submitted a marketing authorization application to the MHLW in November 2010.
Lunesta is a non-benzodiazepine type GABAA agonist that is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in Japan and overseas demonstrated that the agent is effective in those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. A distinctive feature of Lunesta is that patients do not experience clinically problematic issues such as dependency or carry-over effects or develop a tolerance (experience diminished efficacy) with long-term use... Eisai's Press Release -
