Australia. The Adverse Drug Reactions Advisory Committee has received 31 reports associated with the use of midazolam as a sedative or premedication for anaesthesia that describe paradoxical reactions such as agitation (18), aggression (11), abnormal crying (9), hallucinations (7) or emotional lability (3).

Twenty of these cases occurred in children 11 years of age and younger. All of the children recovered, usually after an hour or two, although in two cases the benzodiazepine antagonist flumazenil was used.

Reference: Australian Adverse Drug Reactions Bulletin 17(1): 2 (1998).