| Study | Reason for exclusion |
|---|---|
| Asano 2013 | Not an RCT |
| Asayama 2003 | Participants had no identified sleep problem at baseline |
| Bergener 1968 | Geriatric population with mixed diagnoses. No primary sleep aim. No identified sleep problem at baseline |
| Bergonzi 1973 | Not an RCT |
| Cardinali 2014 | Not an RCT |
| Cohen‐Mansfield 2000 | Not an RCT |
| Cruz‐Aguilar 2013 | Not an RCT |
| Eeles 2003 | Not an RCT (group assignment by birth date) |
| Gehrmann 2009 | Participants had no identified sleep problem at baseline |
| Gillman 1997 | Not an RCT |
| GInsburg 1976 | Not an RCT (incomplete Latin square design). Uncertain diagnoses |
| Haworth 2001 | Trial register entry in 2001 for an investigator‐led trial of melatonin planned for 2001 to 2002. Described in the trial register as 'a pilot study'. We found no evidence that this trial was ever completed and were unable to obtain any information from the author. |
| Howcroft 2005 | Not an RCT |
| Kittur 1999 | Not an RCT |
| Linnoila 1980a | Participants were 19 psychogeriatric inpatients, 7 of whom were identified as having 'senile dementia' |
| Linnoila 1980b | Participants were 20 psychogeriatric inpatients, 10 of whom were identified as having 'senile dementia' |
| Magnus 1978 | Participants were 17 elderly patients with unspecified organic dementia. No identified sleep problems at baseline |
| Mahlberg 2004 | Not an RCT |
| Markowitz 2003 | No identified sleep problem at baseline. Aimed to assess effect of galantamine on sleep but no primary aim to improve sleep. |
| Meguro 2004 | Not an RCT. Participants selected for wandering behaviour |
| Mishima 1992 | Not an RCT. Participants had multi‐infarct dementia |
| Moraes 2003 | No identified sleep problems at baseline |
| Moraes 2006 | No identified sleep problems at baseline. (Patients excluded for severe sleep disturbance) |
| NCT00035204 | No primary aim to improve sleep. No placebo control (comparison of two cholinesterase inhibitors) |
| NCT00480870 | No identified sleep problems at baseline. No primary aim to improve sleep |
| NCT00626210 | Not an RCT |
| NCT00706186 | Study terminated July 2010. Withdrawn by investigator |
| NCT00940589 | No identified sleep problems at baseline |
| NCT01548287 | No identified sleep problems at baseline (confirmed by representative of sponsor) |
| Petit 1993 | No mention of randomised allocation. No identified sleep problems at baseline |
| Riemersma‐van der Lek2008 | No identified sleep problems at baseline |
| Riley McCarten 1995 | Not an RCT |
| Ruths 2004 | No identified sleep problems at baseline. Drug withdrawal study |
| Schubert 1984 | Not an RCT |
| Scoralick 2016 | Only 10/24 included participants were randomised; majority of control data were drawn from an earlier study. |
| Scripnikov 2007 | No primary sleep aim. No identified sleep problems at baseline |
| Shaw 1992 | Participants were elderly psychiatric inpatients, < 50% had dementia |
| Shinno 2008 | Not an RCT |
| Simon Padilla 2009 | Not an RCT |
| Singer 2007 | Not an RCT. |
| Stahl 2004 | No primary sleep aim. (Investigated sleep‐related adverse events in RCTs of galantamine) |
| Stemmelin 2013 | No identified sleep problems at baseline |
| Tozawa 1998 | Identified from Conference proceedings and other literature. Probably a small RCT (7 participants). Minimal information and no results obtainable |
| UMIN000006388 | Not an RCT |
| UMIN000016374 | No placebo control, comparing hypnotic, antidepressant and herbal medicine |
| Valtonen 2005 | No identified sleep problems at baseline |
| Walther 2011 | Planned trial (Swissmedic 2007DR2217) was not completed. Only 2 patients could be randomised, published as case reports |
| Yehuda 1996 | No primary sleep aim. No identified sleep problems at baseline |
Abbreviations
AD = Alzheimer's disease MCI = mild cognitive impairment