QUAZEPAM
Drugs in Pregnancy and Lactation.
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Name: QUAZEPAM
Class: Hypnotic
Risk Factor: XM
Fetal Risk Summary
Quazepam is a benzodiazepine that is used as a hypnotic for the short-term management of insomnia. No major abnormalities were observed in mice and rabbits at doses up to 400 and 134 times the human dose, respectively (1). Minor defects observed in mice were delayed ossification of the sternum, vertebrae, distal phalanges, and supraoccipital bones (1). The manufacturer considers the drug to be contraindicated during pregnancy (1).
No reports of human use of quazepam during human pregnancy have been located, but the effects of this agent on the fetus following prolonged use should be similar to those observed with other benzodiazepines (see also Diazepam). Maternal use near delivery may potentially cause neonatal motor depression and withdrawal.
Breast Feeding Summary
Quazepam is excreted into human milk (2). Four healthy, lactating volunteers, who agreed not to breast-feed their infants, were given a single 15-mg dose of the hypnotic, and blood and milk samples were collected at scheduled times during a 48-hour interval. Mean cumulative amounts of quazepam and its two major active metabolites excreted into milk during the 48-hour period were 11.6 µg (range 2.4–32.8 µg) quazepam, 4.0 µg (range 1.3–10.0 µg) 2-oxoquazepam, and 1.0 µg (range 0.4–1.6 µg) N-desalkyl-2-oxoquazepam. These amounts represented 0.08%, 0.02%, and 0.09% of the dose, respectively. Milk concentrations of quazepam and 2-oxoquazepam were always higher than those in the plasma, with milk:plasma ratios of 4.18 and 2.02, respectively. Because of the lipophilic properties of quazepam, these ratios are much higher than those observed with diazepam (see Diazepam). The investigators estimated that following a multiple-dose regimen, only 28.7 µg/day of the three compounds combined would be excreted into milk, representing 0.19% of the daily dose. Moreover, they concluded that the pharmacokinetics of quazepam indicated that accumulation would not occur, except for N-desalkyl-2-oxoquazepam, the metabolite excreted in milk in the smallest amounts (2).
Although the amounts measured in the above study are small, the effects, if any, on a nursing infant's central nervous system function are unknown. In recognition of this, the American Academy of Pediatrics classifies quazepam, especially when taken by nursing mothers for long periods, as an agent whose effects on an infant are unknown, but may be of concern (3).
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References
- Product information. Doral. Wallace Laboratories, 1994.
- Hilbert JM, Gural RP, Symchowicz S, Zampaglione N. Excretion of quazepam into human breast milk. J Clin Pharmacol 1984;24:457–62.
- Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.
