Structured Abstract
Context:
Sleep disorders affect 50 to 70 million Americans,
representing approximately 20 per cent of the population.
Objectives:
To review the effectiveness of melatonin for the treatment
of sleep disorders; the safety, pharmacology and mechanisms of action of exogenous
melatonin; and the link between endogenous melatonin and circadian rhythms.
Primary Data Sources:
Studies were selected from the following
electronic databases: MEDLINE®, PreMEDLINE®, EMBASE®, PubMed®, CAB Health®, CINAHL®,
AMED®, Cochrane Central Register of Controlled Trials®, Cochrane Complementary
Medicine Field Registry®, Science Citation Index®, Biological Abstracts®,
International Pharmaceutical Abstracts®, NLM Gateway®, OCLC papers First and
Proceedings First®, TOXLINE®, Registry of Toxic Effects of Chemical Substances
(RTECS) ®. Data were also obtained from register of ongoing trials.
Study Selection:
Studies were selected for particular questions of the
review according to pre-determined, question-specific inclusion criteria. Only
English-language reports were included in the review.
Quality Assessment:
The quality of studies was assessed using either
the Jadad Scale for Quality Assessment of Randomized-Controlled Trials or the Downs
and Black Checklist for Quality Assessment of Non-Randomized Controlled Trials.
Allocation concealment in the randomized controlled trials was also assessed.
Data Analysis:
Quantitative Analysis: Data were analyzed using a Random Effects Model. All results were reported
with 95 per cent confidence intervals (95 per cent CI). Sources of heterogeneity
were assessed using the I-squared statistic, and publication bias was assessed using
the Funnel Plot approach, the Rank Correlation Test, the Graphical Test, and the
Trim and Fill Method.
Qualitative Analysis:
Relevant information was summarized and synthesized.
Main Results:
Effectiveness of Exogenous Melatonin: People with a Primary Sleep Disorder: Melatonin decreased sleep onset latency;
it was decreased greatly in people with delayed sleep phase syndrome and marginally
in patients with insomnia. There was no evidence that melatonin had an effect on
sleep efficiency. The magnitude of the effect of melatonin on sleep onset latency in
people with delayed sleep phase syndrome, but not in people suffering from insomnia,
appears to be clinically significant. People with a Secondary Sleep
Disorder: There was no evidence that melatonin had an effect on sleep
onset latency, but it increased sleep efficiency. The magnitude of the effect of
melatonin on sleep efficiency in people with secondary sleep disorders appears to be
clinically insignificant. People Suffering from Sleep Restriction:
There was no evidence that melatonin had an effect on sleep onset latency or sleep
efficiency.
Safety of Exogenous Melatonin:
There was no evidence of adverse effects of melatonin with short-term
use.
Main Conclusions:
Evidence suggests that melatonin is not effective in treating most primary
sleep disorders with short-term use, although there is some evidence to
suggest that melatonin is effective in treating delayed sleep phase syndrome
with short-term use. Evidence suggests that melatonin is not effective in treating most secondary
sleep disorders with short-term use. No evidence suggests that melatonin is effective in alleviating the sleep
disturbance aspect of jet lag and shift-work disorder. Evidence suggests that melatonin is safe with short-term use.
Prepared for: Agency for Healthcare Research and Quality, U.S. Department
of Health and Human Services.1
Contract No. 290-02-0023.
Prepared by: University of Alberta
Evidence-based Practice Center, Edmonton, Alberta, Canada.
Suggested citation:
Buscemi N, Vandermeer B, Pandya R, Hooton N,
Tjosvold L, Hartling L, Baker G, Vohra S, Klassen T. Melatonin for Treatment of
Sleep Disorders. Evidence Report/Technology Assessment No. 108. (Prepared by the
University of Alberta Evidence-based Practice Center, under Contract No.
290-02-0023.) AHRQ Publication No. 05-E002-2. Rockville, MD: Agency for
Healthcare Research and Quality. November 2004.
This report may be used, in whole or in part, as the basis for development of
clinical practice guidelines and other quality enhancement tools, or a basis for
reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human
Services endorsement of such derivative products may not be stated or implied.
AHRQ is the lead Federal agency charged with supporting research designed to improve
the quality of health care, reduce its cost, address patient safety and medical
errors, and broaden access to essential services. AHRQ sponsors and conducts
research that provides evidence-based information on health care outcomes; quality;
and cost, use, and access. The information helps health care decisionmakers—patients
and clinicians, health system leaders, and policymakers—make more informed decisions
and improve the quality of health care services.
The authors of this report are responsible for its content. Statements in the report
should not be construed as endorsement by the Agency for Healthcare Research and
Quality or the U.S. Department of Health and Human Services of a particular drug,
device, test, treatment, or other clinical service.
