Home' Australian Pharmacist : Australian Pharmacist January 2017 Contents Australian Pharmacist January 2017 I ©Pharmaceutical Society of Australia Ltd.
BY DR HANAN KHALIL
Dementia is the second leading cause of
death in Australia and the single greatest
cause of disability in people aged 65
years and over. The total direct costs and
expenditure on the aged care system
was estimated to be $4.9 billion in 2010.
According to the Australian Institute of Health
and Welfare, 353,800 people are living with
dementia in Australia and it is expected that
the number of people diagnosed will reach
almost 900,000 by 2050.
This evidence summary will provide the best available evidence for
the effectiveness of melatonin for managing sleep disturbances in
dementia. For the full Cochrane review, please refer to: McCleery J,
Cohen DA, Sharpley AL. Pharmacotherapies for sleep disturbances in
dementia. Cochrane Database of Systematic Reviews 2016, Issue 11.
Art. No.: CD009178. DOI: 10.1002/14651858.CD009178.pub3.1
nocturnal sleep time, sleep efficiency, nocturnal
time awake, number of nocturnal awakenings, sleep
latency and ration of daytime sleep to night-time
sleep and adverse events.
Secondary outcomes include: carer ratings of
patients’ sleep, cognition, activities of daily living,
quality of life and care burden.
There were a total of four studies including
participants with melatonin. The dose of melatonin
varied between 5 mg to 10 mg of immediate release
melatonin and 2 mg to 6mg of Melatonin SR.
Two studies showed no evidence of an effect of
melatonin on total nocturnal sleep time MD 10.68
minutes, 95% CI -16.22 to 37.59; N = 184 or on the
ratio of daytime sleep to night-time sleep (MD -0.13,
95% CI -0.29 to 0.03); N = 184.
One study showed no significant effect of melatonin
on sleep efficiency (MD -0.01%, 95% CI -0.04 to 0.03);
There was no difference between melatonin and
placebo in sleep efficiency, time awake, after sleep
onset, or the number of nocturnal awakenings.
No serious side effects were reported in the four
The results from the above mentioned review
showed that there is no evidence to support the use
of melatonin in a dose of up to 10 mg in this group
of patients to help with sleep disturbances.
Implications for practice
The current evidence does not support the benefits
of melatonin for sleep disturbances in patients with
dementia. This evidence is derived from only four
studies. Larger studies addressing the benefits of
melatonin in this group of patients are warranted.
Melatonin and other hypnotics should be used with
caution until further evidence emerges.
1. McCleery J, CohenDA, Sharpley AL. Pharmacotherapies for sleep disturbances
in dementia. Cochrane Database of Systematic Reviews 2016, Issue 11. Art.
No.: CD009178. DOI: 10.1002/14651858.CD009178.pub3
2. Australian Institute of Health and Welfare. Dementia in Australia. 2012.
3. Cumming RG, Le Couteur DG. Benzodiazepines and risk of hip fractures in
older people: a review of the evidence. CNS Drugs 2003;17:825–37.
4. Coupland CA, Dhiman P, Barton G, et al. A study of the safety and harms of
antidepressant drug s for older people: a cohort study using a large primary
care database. Health Technology Assessment 2011;15(28):1–202
5. Rogers NL, Dinges DF, Kennaway DJ, Dawson D. Potential action of melatonin in
insomnia. SLEEP-NEW YORK THEN WESTCHESTER- . 2003 Dec 15;26(8):1058–9.
6. Ferracioli-Oda E, Qawasmi A, Bloch MH. Meta-analysis: melatonin for the
treatment of primary sleep disorders. PloS one. 2013 May 17;8(5):e63773.
DR HANAN KHALIL
is the Director of the
Centre for Chronic Disease
Management, a collaborating
centre of the Joanna
Briggs Institute, Faculty
of Medicine, Nursing and
Health Sciences, Monash
University, and a reviewer
for the consumer group of
the Cochrane Collaboration.
She is also Editor in Chief of
the International Journal of
Evidenced Based HealthCare.
Dementia is a collection of symptoms caused by neurodegenerative conditions.
Types of dementia include Alzheimer’s diseases, vascular dementia and Lewy
bodies’ dementia and dementia associated with Huntington’s disease. The
dementia syndrome is characterised by symptoms such as cognitive decline,
apathy, anxiety, agitation and sleep disturbances. Sleep disturbances affect up to
35% of individuals with dementia. Sleep problems often result in a quicker rate of
institutionalisation, increased healthcare costs and caregiver stress.2
Pharmacological management is used to improve sleep problems. Examples of
medications used include atypical antipsychotics, benzodiazepines, zolpidem,
zopiclone, sedating antidepressants and antihistamines and melatonin.3,4
Melatonin is a hormone that is secreted by the pineal gland. Melatonin is
used to treat insomnia in healthy individuals. It has less dependency and
adverse events compared with other medications such as benzodiazepines
and antidepressants.5,6 This evidence summary focuses on the effectiveness of
melatonin for insomnia in people with dementia.
Randomised controlled trials (RCTs) and cross over trials were included.
Participants with any type of dementia were included provided they were
diagnosed with any validated criteria such as the Diagnostic and Statistical
Manual (DSM) or International Classification of Diseases (ICD) criteria.
Participants diagnosed with obstructive sleep apnoea syndrome were excluded.
Studies included in the report had a low risk or an unclear risk of bias. Two studies
had high risk of bias with selective reporting.
The following databases were searched: Medline, Embase, CINAHL, PsychINFO
and LILALCS. This is in addition to the Cochrane Dementia and Cognitive
Impairment Group (CDCIG) and ALOIS (www.medicine.ox.ac.uk/alois).
The primary outcome measure was any sleep outcomes measured with
olysomnography or more practicably for dementia patients including: total
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