Zolpidem in Pregnancy and Breastfeeding
      
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Zolpidem (Ambien )
Hypnotic. Non-benzodiazepine of the imidazopyridine class, shares some of the pharmacological properties of the benzodiazepines. Molecular weight:764.88

Reproductive studies conducted in rats and rabbits showed no teratogenic effects after zolpidem administration. In rats and rabbits no fetal toxicity was noted at 5 times and 7 times the maximum human dose (on a mg/m 2 basis) respectively.  [1]

In rats, adverse maternal and fetal effects occurred at 20 and 100 mg base/kg and included dose-related maternal lethargy and ataxia and a dose-related trend to incomplete ossification of fetal skull bones. In rabbits there was an increase in postimplantation fetal loss and underossification of sternebrae in viable fetuses at the dose of 16 mg base/kg. These fetal findings in rabbits are often secondary to reductions in maternal weight gain  [1].

One case report suggests zolpidem crosses the human placenta [8].

Although animal studies have been reassuring data on the use of zolpidem during human pregnancy is minimal. In one observational study from England first trimester exposure in 18 pregnancies (including one set of twins) resulted in delivery of 11 normal infants and two spontaneous abortions. Six women chose to have elective abortions [2].

BREAST FEEDING: Excretion of zolpidem into human milk appeared to be very low (less than 0.02% of the total administered dose) in a study of five lactating women treated with a single 20 mg dose of zolpidem. The milk:plasma ratio was 0.13 at 3 hours [3]. The American Academy of Pediatrics considers zolpidem to be compatible with breastfeeding [4].


NEONATAL SIDE EFFECTS: Although withdrawal may occur with excessive doses of zolpidem, the incidence of rebound insomnia or withdrawal symptoms after discontinuation of the drug when it is given as recommended appears to be much lower than that of benzodiazepines [5-7]. Nonetheless children born of mothers taking sedative/hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born of mothers who received sedative/hypnotic drugs during pregnancy. [1]

SEARCH LITERATURE

1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 3008
2. Wilton LV, Pearce GL, Martin RM et al: The outcomes of pregnancy women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 105:882-889, 1998. MEDLINE
3. Pons G, et al., Zolpidem excretion in breast milk. Eur J Clin Pharmacol. 1989;37:245-8. MEDLINE
4. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-89.
5. Aragona M.Abuse, dependence, and epileptic seizures after zolpidem withdrawal: review and case report.Clin Neuropharmacol. 2000;23:281-3. MEDLINE
6. Hajak G, et al., Abuse and dependence potential for the non-benzodiazepine hypnotics zolpidem and zopiclone: a review of case reports and epidemiological data.Addiction. 2003;98:1371-8 MEDLINE
7. Holm KJ and Goa KL.Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs. 2000;59:865-89. MEDLINE
8. Askew JP.Zolpidem addiction in a pregnant woman with a history of second-trimester bleeding.Pharmacotherapy. 2007 Feb;27(2):306-8.PMID: 17253922  

Created: 11/30/2002
Update: 12/26/2003
Update: 1/12/2009  

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