Finnerty 1978.

Methods	Double‐blind, randomised study
Participants	Insomnia diagnosis criteria (method of diagnosis): no formal insomnia diagnosis mentioned, instead "Patients with sleep disturbance were considered for treatment." Other diagnoses: neurotic depression and minimum score of 7 on Raskin Scale for Depression Number of participants randomised: n = 139 Doxepin: n = 71 Imipramine: n = 68 Number of participants: n = 97 Doxepin: n = 49 Imipramine: n = 48 Age, mean (range) years: Doxepin: 38.5 (20‐67) Imipramine: 38.6 (19‐65) Gender (M/F): Doxepin: 20/29 Imipramine: 16/32 Race/ethnicity: not reported Country: Boston and Philadelphia, USA Setting: 2 outpatient treatment and research centres Included: people with primary diagnosis of neurotic depression with a minimum score of 7 on the Raskin Scale for depression and with sleep disturbance symptoms. Excluded: people with physical contraindications such as glaucoma, urinary retention, severe organic disease or the potential to become pregnant; history of alcoholism; sensitivity to tricyclic antidepressants; who received MAOIs or any other psychotropic drug in 2 weeks prior to study. Withdrawals: n = 42 Doxepin: n = 22 (failure to keep study visit n = 7: drug toxicity n = 13; intercurrent illness n = 1; violation of protocol n = 1) Imipramine: n = 20 (failure to keep study visit n = 10; drug toxicity n = 10) Baseline imbalances: fewer men than women in the imipramine group and in comparison with the doxepin group
Interventions	Intervention: doxepin taken before bedtime; initial dose 100 mg, could be titrated to 150 mg after 1 week of treatment and up to 200 mg after 2 weeks of treatment (mean dose 112.7 mg/day) Comparator: imipramine taken before bedtime; initial dose 100 mg, could be titrated to 150 mg after 1 week of treatment and up to 200 mg after 2 weeks of treatment (mean dose 116.7 mg/day)
Outcomes	Primary outcomes HAM‐D Finnerty‐Goldberg Sleep scale Sleep Disturbance Factor Secondary outcome Adverse effects
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated pattern of randomisation in groups of 4 (Pg 853, second paragraph)
Allocation concealment (selection bias)	Unclear risk	No details given, but reported double blind
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No details given, but reported double blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details given, but reported double blind
Incomplete outcome data (attrition bias) All outcomes	High risk	42/139 participants did not complete the study, i.e. 30% (Pg 853, "Results"); no ITT
Selective reporting (reporting bias)	High risk	Finnerty‐Goldberg scale used to assess sleep disturbance, but findings not reported in full (Pg 853)
Other bias	Unclear risk	No disclosure of conflicts of interest