Reynolds 2006.

Methods	Randomised, double‐blind, controlled trial
Participants	Insomnia diagnosis criteria (method of diagnosis): DSM‐IV primary insomnia: difficulty initiating or maintaining sleep or non‐restorative sleep for ≥ 1 month; clinically significant distress or functional impairment; sleep disturbance did not occur exclusively during the course of narcolepsy, breathing‐related sleep disorder, circadian rhythm disorder or parasomnia; disturbance did not occur exclusively during the course of another mental health disorder; disturbance was not the result of the direct physiological effects of a substance or a general medical condition Clinical assessment was by a study investigator and the project co‐ordinator used SCID for DSM‐IV to determine diagnosis. Other diagnoses: adults aged > 55 years with primary insomnia Number of participants randomised: n = 27 Number of participants: n = 27 Paroxetine: n = 14 Placebo: n = 13 Age, mean (SD) years: Paroxetine: 67.4 (10.5) Placebo: 66.5 (7.4) Gender: not reported Race/ethnicity: not reported Country: USA Setting: clinical referral and media announcements night‐time monitoring was undertaken at the Western Psychiatric Institute and Clinic, Clinical Neurosciences Centre, Pittsburgh, USA Included: aged ≥ 55 years and meeting DSM‐IV primary insomnia (see above) Excluded: if PSG showed sleep‐disordered breathing or periodic limb movements; if urine toxicology showed benzodiazepine or other substances Withdrawals: n = 7 Paroxetine: n = 4 (failure to improve n = 2, rash n = 3, daytime stimulant use n = 1) Placebo: n = 3 (failure to improve n = 2, respondent burden n = 1) Baseline imbalances: reported the 2 treatment groups did not differ significantly on any demographic or clinical measures (Pg 804, first paragraph)
Interventions	Intervention: paroxetine 10 mg + sleep hygiene (initially adjusted after 2 weeks based on presence of possible adverse effects up to maximum 20 mg/day) adjusted under double‐blind conditions Duration: 6 weeks Comparator: placebo + sleep hygiene (10 mg initially adjusted after 2 weeks based on presence of possible adverse effects up to maximum 20 mg/day) adjusted under double‐blind conditions
Outcomes	Primary outcomes Diagnostic response status Diary‐based measures Secondary outcome PSG
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly assigned," but nothing else (Pg 804).
Allocation concealment (selection bias)	Unclear risk	No details given
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Reported double blind in abstract and on Pg 804, but did not say what placebo was or whether looked identical
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Reported blinded evaluator at 6 weeks (Pg 804)
Incomplete outcome data (attrition bias) All outcomes	High risk	Numerous withdrawals (Pg 804). Not ITT
Selective reporting (reporting bias)	Low risk	No details given
Other bias	Low risk	Full disclosure, no pharmaceutical company influenced the result