Camargos 2014.

Study characteristics
Methods	RCT, 2 parallel treatment groups
Participants	Number of participants: 36 randomised, data available for 30 Country: Brazil Setting: outpatients of a Geriatric Medical Centre Diagnosis: probable AD (NINCDS‐ADRDA criteria) Sleep‐related inclusion criteria: insomnia – complained of by patient or observed by carer; researcher judged the insomnia to be due to the dementia; the sleep disorder caused emotional distress to the carer (NPI ≥ 2) Gender: 20 women, 10 men Age: 81.0 (SD 7.5) years Severity of dementia: MMSE 11.2 (SD 6.2)
Interventions	Duration of treatment: 2 weeks Treatment group 1 (n = 15): trazodone 50 mg once daily Treatment group 2 (n = 15): placebo Route of administration: oral Time of administration: 10 p.m.
Outcomes	Single actigraph records were created for the 7‐ to 9‐day screening/baseline and 2‐week treatment periods Primary: TNST night‐time waking after sleep onset night‐time number of awakenings dTST number of daytime naps (> 10 minutes) night‐time percent sleep (sleep efficiency) gain of > 30 minutes in TNST Secondary: cognitive function (MMSE, Paired Associate Learning Test forms I & II of Wechsler Memory Scale, Digit Span Test, Arithmetic, Letter‐Number Sequencing, Digit Symbol‐Coding, and Symbol Search of the WAIS‐III ADL (Katz Index of Independence in Activities of Daily Living) tolerability and AEs (collected by spontaneous report) subjective analysis of sleep improvement by carer
Notes	Adherence to treatment > 85% in all participants Non‐commercial funding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Online random number generator (www.random.org) was used by 1 investigator to produce random alphanumeric, 3‐digit codes. These then were used by external pharmacist to label tablet bottles. Bottles were handed "in scrambled order" to clinical pharmacist to dispense.
Allocation concealment (selection bias)	Low risk	Allocation sequence known only to 1 investigator who took no further part in study, inaccessible to recruiting clinicians or clinical pharmacist.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Both the medication pills and the equivalent placebos were received in bulk from the sole manufacturer of trazodone in Brazil (Apsen Laboratory®), and the placebos were prepared to be indistinguishable in appearance with trazodone prepared as 50‐mg pills. The bottles of trazodone or placebo had the same size." Quote: "All patients and geriatricians were blinded to the treatment assignment."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "All patients and geriatricians [outcome assessors] were blinded to the treatment assignment, and the final randomization list was not accessed until the clinical database was completed." Note: confirmed by author to mean after actigraphic analysis was completed.
Incomplete outcome data (attrition bias) All outcomes	Low risk	After randomisation, 1 participant was excluded from each group for clinical reasons (heart failure secondary to non­compliance with other medication, episode of agitation leading to arm fracture), and 4 participants (3 trazodone, 1 placebo) due to technical failure of actigraphy. We judged these exclusions to be unlikely to lead to bias.
Selective reporting (reporting bias)	Low risk	All outcomes reported.
Other bias	Low risk	None identified.