ProSom and Pregnancy
Human and animal studies involving pregnancy and benzodiazepines (including ProSom) have shown that the medication increased the risk of birth defects and can cause withdrawal symptoms in a newborn. Therefore, the FDA has classified it as a pregnancy Category X medication, meaning it should not be taken during pregnancy. If you are taking ProSom and pregnancy occurs, be sure to let your healthcare provider know.
ProSom and Pregnancy: An OverviewProSom® (estazolam) is a prescription medication approved for the treatment of insomnia. It should not be taken during pregnancy. ProSom is part of a group of medications known as benzodiazepines. Human and animal studies have shown that using benzodiazepines during pregnancy can increase the risk of birth defects and other problems.
ProSom and Pregnancy Category XThe 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 X is given to medicines that show problems to the fetus in animal studies or in women who have taken the drug. Also, a pregnancy Category X rating is given when the potential risks of a medication outweigh any possible benefits when used during pregnancy.
ProSom was given a pregnancy Category X rating because it is a benzodiazepine. Using benzodiazepines during early pregnancy may increase the risk of birth defects, while using it later in pregnancy can cause withdrawal symptoms in a newborn. Although very little information is available about the use of ProSom during pregnancy, it is assumed that the drug will have the same problems as other benzodiazepines.
Because it is never absolutely necessary to take ProSom, it should not be taken during pregnancy.