Intermezzo and Pregnancy

Animal studies on Intermezzo (zolpidem sublingual tablet) have suggested that this drug may not be safe for use during pregnancy. When the active ingredient in this medication was given to pregnant rats and rabbits, it appeared to increase the risk for miscarriages and problems in bone formation. However, there may be situations during a pregnancy where the benefits of Intermezzo outweigh the potential risks.

Can Pregnant Women Take Intermezzo?

Intermezzo® (zolpidem sublingual tablet) is a prescription sleep medication. Based on the results of animal studies, this product may not be safe for use during pregnancy, although the full risks are currently unknown.
 

What Is Pregnancy Category C?

Intermezzo is classified as a pregnancy Category C drug. The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy.
 
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When given to pregnant rats at high doses, zolpidem (the active ingredient in Intermezzo) caused problems in bone formation of the fetal skull. When given to pregnant rabbits at high doses in early pregnancy, zolpidem increased the risk of miscarriages and problems in bone formation. When given later in pregnancy and during lactation, zolpidem decreased the pup survival and growth. However, none of the animal studies suggested that Intermezzo caused birth defects.
 
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including Intermezzo, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
 
While zolpidem has not been adequately studied in pregnant women, a number of cases of problems have been reported. These reports involved newborns who were exposed to zolpidem or other similar medications while the mother was pregnant. Some of these reported problems included:
 
  • Breathing problems
  • Withdrawal symptoms, as zolpidem can be habit-forming
  • Floppy, weak muscles.
 
Pregnancy and Pain

Intermezzo Medication Information

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