The new indication for hydroxyzine in syrup form as a hypnotic drug for children over the age of 3 is unacceptable. Hydroxyzine's efficacy for this use has never been proven, while its numerous, sometimes serious, adverse effects have been well known for several years: neurological and psychological disorders, serious allergic reactions. In addition to its negative benefit-harm balance, hydroxyzine syrup contains alcohol and terpenic derivatives, which can cause convulsions.
Furthermore, as the bottle does not have a child safety cap, patients are exposed to an increased risk of poisoning. The oral syringe is graduated in ml, whereas dosage is given in mg, which can result in miscalculation and overdose.
In short, not only is this drug ineffective in treating sleeping difficulties in children, it also exposes them to potentially serious risks.
Treating sleeping difficulties in children relies above all on healthy sleeping habits (a calm environment, appropriate bedtime and wake-up time) or if necessary a behavioural approach.
©Prescrire 1 January 2008
Source: "Difficultés d'endormissement chez les enfants : non aux médicaments !" Rev Prescrire 2008; 28 (291): 7.
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