Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis.
OBJECTIVE
To conduct a systematic review of the efficacy and safety of exogenous melatonin in managing secondary sleep disorders and sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder.


METHODS
13 electronic databases and reference lists of relevant reviews and included studies; Associated Professional Sleep Society abstracts (1999 to 2003).


METHODS
The efficacy review included randomised controlled trials; the safety review included randomised and non-randomised controlled trials.


METHODS
Randomised controlled trials were assessed by using the Jadad Scale and criteria by Schulz et al, and non-randomised controlled trials by the Downs and Black checklist.


METHODS
One reviewer extracted data and another reviewer verified the data extracted. The inverse variance method was used to weight studies and the random effects model was used to analyse data.


RESULTS
Six randomised controlled trials with 97 participants showed no evidence that melatonin had an effect on sleep onset latency in people with secondary sleep disorders (weighted mean difference -13.2 (95% confidence interval -27.3 to 0.9) min). Nine randomised controlled trials with 427 participants showed no evidence that melatonin had an effect on sleep onset latency in people who had sleep disorders accompanying sleep restriction (-1.0 (-2.3 to 0.3) min). 17 randomised controlled trials with 651 participants showed no evidence of adverse effects of melatonin with short term use (three months or less).


CONCLUSIONS
There is no evidence that melatonin is effective in treating secondary sleep disorders or sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. There is evidence that melatonin is safe with short term use.
University of Alberta/Capital Health Evidence-based Practice Centre, Department of Pediatrics, University of Alberta, Edmonton, AB, Canada T6G 2J3. nina.buscemi@ualberta.ca
Nina
N
Buscemi
Ben
B
Vandermeer
Nicola
N
Hooton
Rena
R
Pandya
Lisa
L
Tjosvold
Lisa
L
Hartling
Sunita
S
Vohra
Terry P
TP
Klassen
Glen
G
Baker
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008550:Melatonin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012893:Sleep Wake Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
D008550:Melatonin