Page 29 - Demo

FEATURE
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.
EVIDENCE SUMMARIES
Melatonin for
sleep disturbances
in dementia
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 2050.2
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.
Study characteristics
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.
Research quality
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.
Results
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
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); N = 151.
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 studies.
Conclusion
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.
References
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.
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
Australian Pharmacist January 2017 I ©Pharmaceutical Society of Australia Ltd. 27