Mellman 2002.

Methods	Design: randomised, placebo‐controlled trial Duration of intervention: 7 days Follow‐up: the final assessment for the trial was 6 weeks after the initial assessment Placebo run‐in: no
Participants	Sample size: 22 participants were randomised to temazepam and placebo Mean age: 36.1 (11.4) Gender: 14 men and 8 females Ethnicity: 18 Hispanic, 2 white and 2 black participants Type of trauma: motor vehicle accidents, industrial accidents and impersonal assaults Diagnostic measure: DSM‐IV Inclusion criteria: participants were recruited from a much larger pool of injured patients on the basis of having recall of the incident and endorsing at least moderate impairment of sleep initiation or maintenance and meeting full criteria for at least 2 PTSD symptoms clusters (DSM‐IV) during a structured interview assessment, and the ability and willingness to provide written informed consent Exclusion criteria: intoxication at the time of the incident, brain injury and pre‐existing active psychiatric disorders Drop‐outs: 0 Number of participants with MDD: 0
Interventions	Pharmacological intervention: Quote: "Subjects were randomly assigned to placebo taken at bedtime for seven nights or 30mg of temazepam at bedtime for five nights followed by 15mg for two nights"
Outcomes	Primary outcomes: CAPS and sleep diary measure Secondary outcomes: not specified
Notes	Industry‐funded: yes. Supported by grant MH54006 from the National Institute of Mental Health, Bethesda Medication provided by industry: no Any of the authors work for industry: no
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Predetermined randomisation schedule
Allocation concealment (selection bias)	Low risk	Medication schedule was known only to the research pharmacist (TA Mellman; personal correspondence: 09 September 2011)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Medication was placed in identical capsules (TA Mellman; personal correspondence: 09 September 2011)
Blinding of outcome assessment (detection bias) All outcomes	High risk	No information was provided on the blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no drop‐outs reported during this study
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available for this study
Other bias	High risk	Study was terminated at 6 weeks after initial assessment, or in 50% of cases when non‐study medications were indicated. Quote: "The final assessment for the trial was 6 weeks after the initial assessment or, in one half of cases, just prior to initiating nonstudy medication, which was initiated on the basis of the clinical judgment of the investigators when insomnia and/or other PTSD‐related symptoms that were distressing to the subject did not diminish during or shortly after the trial (intent‐to‐treat analysis)"