Can alimemazine (Theralen) be given for sleeping difficulties during pregnancy?/nAre there other al

Fråga: Can alimemazine (Theralen) be given for sleeping difficulties during pregnancy?

Are there other alternatives, except benzodiazepines?

A heroin-addicted woman is pregnant in gestational week 13 or 14 and has recently joined the Methadone programme. She has sleeping difficulties and demands alimemazine.

Sammanfattning: The use of alimemazine could not be encouraged during pregnancy. There are other alternatives judged to be safe during pregnancy.

Svar: Alimemazine (called trimeprazine in the US (1)) is a phenothiazine in the group of high-dose neuroleptics with antiemetic, sedating and antipruritic properties (2). It is sometimes classified as an antihistamine (1). The experience of use during pregnancy is limited. In the Swedish Medical Birth Register there is 70 children exposed to alimemazine during early pregnancy, two of which (2.8%) had a malformation (one preauricular appendage and one atrial septal defect) (3). In the present case, given that the stated pregnancy duration is correct, organogenesis should be complete and there should be no risk of teratogenesis. Other phenothiazines have, when used later in pregnancy, caused long-lasting but reversible extrapyramidal disturbances in the baby (2).

Propiomazine (Propavan) is pregnancy category A in Fass (the Swedish catalogue of approved medical products). It is also a phenothiazine derivative with less peripheral side effects (2). In the Swedish Medical Birth Register, there are 595 children exposed to propiomazine during early pregnancy with no increased proportion of malformations (3).

Zopiclone and zolpidem are non-benzodiazepine hypnotics acting on the GABA-A-receptor (2). In the Swedish Medical Birth Register there are 435 pregnancies exposed to zopiclone and 344 exposed to zolpidem without any signs of teratogenicity (3). With these drugs there is a risk of tolerance and dependency and even abuse. This risk seems to be considerably lower than with benzodiazepines, but higher in individuals with a history of substance dependence (4).

Temporary or short-term use of hypnotics during pregnancy is probably safe. The effects on neurological development after regular use of sedatives during pregnancy have, however, not been studied. Long-term or continuous use cannot be encouraged. With long-term use or high doses during late pregnancy, there might be a risk of hypotonia, hypothermia and respiratory disturbancies in the neonate (2,3). Sweetman SC, editor. Martindale, The complete drug reference. 33rd ed. London: Pharmaceutical Press; 2002 Fass 2004 Läkemedel och fosterskada. Uppdated 2003-12-29. Available from: URL: http://www.janusinfo.se Hajak G, Muller WE, Wittchen HU, Pittrow D, Kirch W. Abuse and dependence potential for the non-benzodiazepine hypnotics zolpidem and zopiclone: a review of case reports and epidemiological data. Addiction 2003;98(10):1371-8.