Ambien and Pregnancy

From Pharmacy Drug Guide

Ambien (zolpidem) is a prescription sedative-hypnotic, approved by the FDA in 1992, used to treat sleep problems like insomnia. Ambien works to calm the brain, helping the patient to sleep. It reduces sleep latency, or the time it takes to go from wakefulness to sleep. While some doctors prescribe Ambien during pregnancy, the FDA has rated Ambien as Pregnancy Category C. This means that sufficient human studies have not been done, while animal studies suggest potential harm. Doctors may prescribe Category C medications to pregnant patients if necessary.^{[1] [2] [3]}

Ambien is a controlled substance because patients may abuse it or become dependent on it. It is often prescribed for no more than 7 to 10 days. Patients who have been taking Ambien regularly may initially have some difficulty falling asleep when they stop taking it. Some patients taking Ambien have reported taking part in activities while asleep, such as walking, driving, and preparing and eating food. Sanofi-aventis warns that patients should contact their doctors if they experience such activities during sleep while taking Ambien.^{[1] [2] [3]}

Contents 1 Prescription Drugs 2 Ambien and Pregnancy Category C 3 Ambien and Breastfeeding 4 References

Prescription Drugs

Ambien and Pregnancy Category C

There are no adequate studies of Ambien in pregnant women. Animal studies show some adverse effects at doses exceeding the equivalent maximum human dose. Therefore, based on animal studies, use of Ambien by pregnant women may cause harm to the fetus. Cases of respiratory depression in newborn infants have been reported when Ambien was used at the end of pregnancy, and some newborns may experience withdrawal symptoms. The FDA has determined that Ambien and Ambien CR are Pregnancy Category C, and should only be prescribed if the potential benefits to the mother outweigh potential risks to the fetus.^{[1] [2]}

In a small study of pregnant women conducted in 2009, the group of women taking Ambien had greater rates of preterm delivery and low birth weight than the control group. It was also confirmed that Ambien crosses the human placenta.^[4] Another study found that pregnant women who received Ambien were more likely to experience problems with pregnancy such as low-birth-weight infants, preterm deliveries, delivery of small-for-gestational-age infants, and cesarean delivery.^[5]

Ambien and Breastfeeding

Ambien is excreted in human milk, and the effect of Ambien on nursing infants is not known. However, because Ambien has a fairly short half-life, amounts of Ambien found in breast milk are low. Because comprehensive, long-term tests have not yet been done, the FDA currently recommends that patients should not take Ambien while breastfeeding.^{[1] [2] [3]}

Also See: Drugs and Pregnancy, Ambien, Ambien Side Effects, Ambien Patient Assistance Programs, Ambien Coupons, Ambien Free Samples, Sanofi Aventis Patient Assistance Programs, Valium and Pregnancy, Drug Side Effects, Prescription Drugs

References

1. ↑ ^{1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8} http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=40225
2. ↑ ^{2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8} http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=40200
3. ↑ ^{3.0 3.1 3.2} http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000928/
4. ↑ http://www.ncbi.nlm.nih.gov/pubmed/19657707
5. ↑ http://www.ncbi.nlm.nih.gov/pubmed/20686480