Flunitrazepam: Acute Benefit-Risk Assessment in General Practice

Abstract

A methodology is described which is practical in assessing the benefit-risk ratio of a single new drug prior to marketing. Flunitrazepam at doses of 0·5 mg, 1·0 mg (and 2 mg) node in 2,435 patients is shown to be effective in 78% of patients and the acute risk, predictable and low, irrespective of age or dose. One may conclude that the acute benefit-risk ratio is acceptable with respect to the class of drug and indication for which flunitrazepam is prescribed.