A pharmaceutical company, Somazon Pharmaceuticals, says that its new drug, Silenor, is the first prescription sleep medication which has no potential for over-use or abuse.

It is effective in patients who can’t get to sleep—insomnia—or who cannot stay asleep–which is called “sleep maintenance.”

The sample size was more than 1,000 patients—580 with insomnia and 437 without.

Dosage safety and effectiveness was tested in 1mg., 3 mg. and 6 mg. tablets.

In recent years, there have been concerns about the fact that the FDA does not do post-approval drug-testing. The agency relies on physician self-reporting which works only as well as the doctor having time to report or identifying that the patient’s problem is associated with a specific drug.

Millions of patients take sleep medication. They need to be sure it is as safe as believed.

This would be a good place to start.

Medpage Today

“The FDA has approved doxepin (Silenor) for use in patients with long or short term insomnia and sleep maintenance difficulty.

“The drug is the first approved prescription sleep aid without abuse potential, a prepared statement from drug manufacturer Somaxon Pharmaceuticals said. The company noted that Silenor “demonstrated maintenance of sleep into the seventh and eighth hours of the night, with no meaningful evidence of next-day residual effects.”

“Drug approval was based on data from 12 randomized, placebo-controlled clinical trials with a combined 1,017 patients, testing 580 patients with insomnia and 437 patients without the condition. Trials took place over intervals as long as three months and tested drug safety and efficacy in doses of 1 mg, 3 mg, and 6 mg.”

Source: Medpage Today, March 19, 2010