Abstract: Objective To find out about the current off-label use of clonazepam and provide data for formulating related specifications in a psychiatry department. Methods The off-label use of clonazepam was analyzed based on drug instructions, literature research as well as retrospective analysis of the outpatient prescriptions of clonazepam in our hospital from June 2017 to June 2018. Results A total of 7 200 prescriptions related to psychotropic drugs of category were retrieved, 1080 of which involved clonazepam, and in 972 of the 1 080 prescriptions off-label use of clonazepam was found. The rate of off-label usage was as high as 90.00%. Among the cases of off-label use, 95.06% were related to indications and 4.94% to the dose. The top four diseases involving off-label use of clonazepam were anxiety, sleep disorder, insomnia and depression. The rates of off-label prescriptions by doctors at all levels were basically the same, with no significant difference (χ²=0.77, 3.24, 1.33, P>0.05). Conclusion The off-label use of clonazepam in the outpatient pharmacy is relatively common in our hospital, which is sometimes acceptable and necessary clinically. Guidelines for off-label drug use are urgently needed to supervise and protect physicians and ensure patients' safety. Meanwhile, irrational use should be contained to lower drug-induced risks.

Key words: clonazepam, off-label drug use, rational drug use