FDA approves new insomnia drug
Washington, D.C, United States
November 28, 2011 10:56 am EST
Health, Medical Conditions, Politics, Regulatory Policy And Organization
The first insomnia drug for people who wake in the middle of the night and then have trouble getting back to sleep has been approved by the Food and Drug Administration.
The FDA says that Intermezzo (ziopodem tartrate sublingual tablets) should only be used when a person has at least four hours of bedtime remaining. It should not be be taken in combination with any other sleep aids or with alcohol.
Zoipidem tartrate was first approved in 1992 in the United States under the name of Ambien. Intermezzo is a lower dose formula of zoipiderm.
The recommended and maximum doses are 3.5 milligrams for men and 1.75 mg for women, taken once per night. The doses for women are lower due to the fact that women's bodies take longer to clear the drug from their system.
The approval is based on two clinical trials of more than 370 patients. Patients who took the drug nodded off quicker than those who took a placebo.
The FDA warns that like other sleep aids, Intermezzo is not without side effects. They include getting out of bed when not fully awake and doing an activity that you don't know that you are doing or have done. Common side effects include headaches, nausea and fatigue.
Intermezzo is a federally controlled substance because it can be abused or lead to dependence.
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