FDA approves Edluar as short-term treatment of insomnia

Orexo, based in Uppsala, Sweden, has announced the U.S. Food and Drug Administration (FDA) has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Meda, Orexo’s partner, acquired exclusive worldwide commercial licensing for Edluar in 2008 with expectations to launch the product in the U.S. market during the second half of 2009. Orexo will receive royalties based on Meda’s sales of Edluar.

This approval triggers a milestone payment to Orexo from Meda. The amount of the milestone is $5 million in U.S. dollars and is based upon the product labeling.

Commenting on the news Torbjörn Bjerke, Orexo’s chief executive officer, said he was “delighted the FDA has approved Edluar for the treatment of short-term insomnia. This is a great achievement by Orexo. Edluar provides a convenient sublingual administration and we believe that this offers insomnia sufferers an effective alternative. This is the second product approved in a major market within 12 months and is an excellent achievement.”

About Edluar
Edluar (formerly known as Sublinox) is a fast-acting, sublingual formulation of the well-known substance zolpidem and has been approved for the temporary treatment of insomnia. It is based on Orexo’s sublingual technology, involving a tablet placed under the tongue for fast and effective absorption of the active substance across the oral mucosa.

About Insomnia
Insomnia is the disturbance of a normal sleep pattern, characterized by the inability to fall asleep, or to stay asleep long enough to get a proper night’s sleep. It is thought to affect one-in-four adults at some point during their lives.

According to the U.S. Department of Health and Human Services, approximately 64 million Americans suffer from insomnia on a regular basis each year. Insomnia occurs 1.4 times more commonly in women than in men.
Insomnia can last for days, months or years and can be split into three categories:

• Transient insomnia, which lasts for two-to-three days
• Short-term insomnia, which lasts for more than a few days, but less than three weeks
• Chronic insomnia, which can be defined as insomnia most nights for three weeks or longer

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Tagged as: chronic insomnia, Edluar, FDA, Food and Drug Administration, Insomnia, insomnia sufferers, Meda Pharmaceuticals, normal sleep patterns, oral mucosa, Orexo, product labeling, proper night's sleep, short-term insomnia, short-term treatment, sleep disturbances, sleep initiation, stay asleep, sublingual administration, Sublinox, transient insomnia, Uppsala Sweden, zolpidem