• The use of Xyrem during pregnancy is not recommended.
• Although animal studies did not show an increased risk of birth defects, there was an increased number of stillbirths and post-birth deaths in baby rats.
• Few pregnant women have been given Xyrem (sodium oxybate). This means data on its effects during pregnancy are limited.
• Sodium oxybate given to women during labor for anesthesia caused a decreased frequency of uterine contractions in the mother and sleepiness in newborns.
• Exposure to sodium oxybate during the first trimester may be associated with an increased risk of spontaneous abortions. Exposure in subsequent trimesters does not appear to do lasting harm to the fetus; however, numbers of pregnant women exposed are extremely small, and it may harm.
• Xyrem readily crosses the placenta and should not be given to pregnant women unless the perceived benefits far outweigh the risks.
• The FDA has not assigned a pregnancy category to Xyrem.

Xyrem (sodium oxybate) is a CNS depressant that may be used to treat narcolepsy.

There is not enough data to properly assess the impact of giving Xyrem to pregnant women. However, the following is known:

• Sodium oxybate given to pregnant rats during organogenesis did not appear to cause developmental toxicity or birth defects in baby rats. Organogenesis in humans occurs anywhere between the third to eighth week of gestation and is the stage during which three germ layers of the embryo form into the major organs of the body system.
• Sodium oxybate that was administered to rats throughout pregnancy and lactation resulted in an increased number of stillbirths, an increase in the number of deaths in the baby rats once born, and decreased growth rates in those baby rats that survived.
• The effects of Xyrem have not been formally studied in labor or delivery. However, in women given sodium oxybate during childbirth, newborns were very sleepy, causing a slight decrease in Apgar scores, although cardiovascular and respiratory measures were stable. The frequency of uterine contractions also fell 20 minutes after the injection.
• Research has also shown that sodium oxybate quickly crosses from the mother’s bloodstream into the placenta, and can be detected in a newborn's bloodstream. The effects of this on an infant's subsequent growth, development, and maturation are unknown.
• A small number of pregnant women have been exposed to sodium oxybate during the first trimester. There appeared to be a possible increased risk in the number of spontaneous abortions. Babies of women exposed in the second or third trimester did not appear to suffer any birth defects or toxicity; however, very few women have been studied.
• Because Xyrem is a central nervous system (CNS) depressant and slows down brain activity, it would not be appropriate to expose pregnant women to the drug, unless the perceived benefits were believed to outweigh the risks.
• The US FDA has not assigned a pregnancy category to Xyrem.