Background:

Eight out of ten patients in the Intensive Care Unit of the Instituto Nacional de Pediatría do not set the same anxiolytic and sedative effect using generic midazolam (PiSA®) as with the innovative brand (Dormicum, Roche®), although its bioavailability is 100%.

Objective:

To determine significant differences in the sedative effect induced by generic and by innovative midazolam given parenterally.

Materialsand methods:

Randomised crossover study in 24 male Wistar rats allocated into 4 groups (n=6). Each individual was given a dose of 0.5 mg/kg intraperitoneally; sedation levels were determined by the scale of Salamone's scale. Drug concentration in the vials of both brands was determined by high performance liquid chromatography (HPLC).

Results:

The sedative effect of midazolam appeared at the same time for both groups and had the same duration regardless of the brand. The effect tends to be more durable with the innovative, but without statistical significance (ANOVA, p ≤ 0.05). Likely, most animals reached Salamone's sedation level 3 with both brands.

Conclusion:

Both innovative and generic midazolam brands provide the same level of sedative effect, which appears and lasts equally.