Ambien and Pregnancy

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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]

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Ambien nsv.jpg
Flickr: nvaine
Brand name for Zolpidem[1] [2]
Used for Sleep aid[1] [2]
Pregnancy Risk Factor C[1] [2]
Label instructions Women who are pregnant, planning to become pregnant, or breastfeeding may be unable to use Ambien.[1] [2]
Warnings Pregnancy: Based on animal data, zolpidem may cause fetal harm.[1] [2]
Disclaimer The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Susan MacDowell
 
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Contents

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.[3] 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.[4]

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]

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Ambien Adverse Effects

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. [1] [2]

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

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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. http://www.ncbi.nlm.nih.gov/pubmed/19657707
  4. http://www.ncbi.nlm.nih.gov/pubmed/20686480