Oromucosal Midazolam

An oromucosal formulation of midazolam is now available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of generalised convulsive status epilepticus.

Zyamis^® pre-filled syringes are ready to use and are presented in four strengths, as shown in Table 1. Approximately half of the prescribed dose should be administered to each buccal cavity over two to three seconds. If access to each side is difficult, the entire dose may be administered to one buccal cavity over a period of four to five seconds. It is recommended that carers only administer one midazolam dose as the use of a second dose increases the risk of adverse effects, such as respiratory depression. Emergency assistance should be sought if the seizure continues.

A randomised, controlled trial compared the safety and efficacy of oromucosal midazolam and intravenous diazepam for seizure control in children. The study authors found no significant difference in the proportion of patients achieving seizure control or the mean time required to control convulsive episodes. However, apnoea occurred in around 7% of the intravenous diazepam group but was not observed in the oromucosal midazolam group. Potential adverse effects associated with midazolam include sedation, nausea, and vomiting.

Ready-to-use midazolam syringes may address some of the safety concerns associated with the off-label use of midazolam ampoules in this population. Zyamis^® is much simpler to use, an important consideration for parents and carers in emergency situations. The risk of incorrect dosing may be reduced, along with the risk of drug loss or abuse.

Carers must be educated on how to administer this medication safely. Administration instructions can be found in the consumer medicines information (CMI), and training videos are available on the Zyamis^® website.

Table 1. Dosing recommendations for oromucosal midazolam