Flunitrazepam 1999, IL.

Study characteristics
Methods	Allocation: randomised. Blinding: double blind. Design: not stated. Duration: 2 hours. Setting: psychiatric hospital, Israel.
Participants	Diagnosis: schizophrenia (n = 19), schizoaffective disorder (n = 7), bipolar (n = 2, DSM‐IV, Axis I Structured Clinical Interview). n = 28. Age: 20‐60 years (mean 36.8 years). Gender: 13 men, 15 women. Ethnicity: not stated. Consent: need for informed consent waived. History: not stated. Inclusion criteria: active psychosis, disruptive or aggressive behaviour; pronounced psychomotor agitation or violent outbursts; hospitalisation in an acute ward. Exclusion criteria: not stated.
Interventions	Benzodiazepines vs antipsychotics. 1. Flunitrazepam 1 mg IM, single dose (n = 15). 2. Haloperidol 5 mg IM, single dose (n = 13). Participants were monitored for 120 minutes.
Outcomes	Global impression: no improvement*; sedation. Adverse effects/events: EPS. Unable to use ‐ Behaviour: OAS scores (variance not reported).
Notes	*'Improvement' ‐ defined as reduction of ≥ 50% in the OAS score at 90 minutes. Participants in each group were taking additional medications leading up to the study, including the following in the haloperidol group: haloperidol 5‐10 mg/day (n = 4); perphenazine 5‐20 mg/day (n = 5); levomepromazine 50‐200 mg/day (n = 2); zuclopenthixol 25 mg/day (n = 2); and the following in the flunitrazepam group: perphenazine 5‐20 mg/day (n = 4); haloperidol 5‐15 mg/day (n = 6); levomepromazine 75 mg/day (n = 1); zuclopenthixol 25‐50 mg/day (n = 4). 4 participants (2 from each group) were also taking mood stabilisers (carbamazepine and valproic acid) and lorazepam.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised "using a table of random numbers."
Allocation concealment (selection bias)	Unclear risk	Not stated.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not state whether investigators were blinded. Rating scales: trial coauthor administered rating scales used for study. All rating scales (OAS, BPRS and CGI) were completed by author NK, who was blind to the study medications; unclear whether dose adjustment was blind.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up: 100%.
Selective reporting (reporting bias)	Low risk	All measure outcomes were reported.
Other bias	Unclear risk	Funding: not stated. Unsure whether there was potential bias.