Zolpidem Side Effects

Valeant's insomnia drug approved for use in Canada

Valeant Pharmaceuticals International Inc., formerly Biovail Corporation, is a Canadian specialty pharmaceutical company engaged in the application of drug-delivery technologies to improve the clinical effectiveness of medicines. Its therapeutic areas of focus are central nervous system (CNS) disorders, pain management and cardiovascular disease (including Type II diabetes).

Valeant Pharmaceuticals ( TSE:VRX ) (NYSE:VRX) announced Monday its Sublinox drug for the treatment of insomnia has received regulatory approval from Health Canada.

Sublinox is intended for the short-term treatment of insomnia, which is characterized by difficulty in falling asleep, frequently awaking throughout the night, and waking early in the morning.

The categorization of insomnia is often called into question. Some professionals claim it is a symptom, while others characterize it as a disorder. An estimated 50% of adults experience insomnia at least once in a lifetime.

The causes are varied, and can range from jet lag, to stress and drug withdrawl. It may also be related to a more serious medical condition.

The Sublinox drug is an oral, dissolving tablet of zolpidem tartrate, and works by inhibiting certain receptors in the central nervous system, inducing sleepiness.

Because it inhibits only the Omega 1 subunit, Sublinox has fewer side-effects than other drug treatments, like benzodiazepines, which are not selective.

"With this approval, we currently anticipate launching this product in the fourth quarter, just one of several pending product launches that our Canadian operations plan on initiating before the end of the year," said CEO J. Michael Pearson.

The product will be commercialized through a joint venture with Valeant's Canadian subsidiary and Meda AB. Zolpidem tartrate has already been approved in several countries, including the Netherlands and the U.S.

This approval, which is the first of its kind for the drug in Canada, comes amid a strong year for Valeant. The Mississauga, Ontario-based company has acquired several companies throughout 2011, including Sanitas in May for $442 million, PharmaSwiss for $481 million in February, along with Janssen's ortho dermatology division and Sanofi's dermatology unit, both earlier this month.

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