Abstract
Introduction
Up to 40% of older adults have insomnia, with difficulty getting to sleep, early waking, or feeling unrefreshed on waking. The prevalence of insomnia increases with age. Other risk factors include psychological factors, stress, daytime napping, and hyperarousal.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of non-drug treatments for primary insomnia in older people (aged 60 years and older)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2014 (BMJ Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 14 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: cognitive behavioural therapy for insomnia (CBT-I), exercise programmes, and timed exposure to bright light.
Key Points
Up to 40% of older adults have insomnia, with difficulty getting to sleep, early waking, or feeling unrefreshed on waking.
The prevalence of insomnia increases with age. Other risk factors include medical and psychiatric illnesses, psychological factors, stress, daytime napping, and hyperarousal.
Primary insomnia is a chronic and relapsing condition that may increase the risks of accidents. It is chronic insomnia without specific underlying medical, psychiatric, or other sleep disorders.
This review only covers primary insomnia in older people (aged 60 years and older). It examines evidence solely from RCTs and systematic reviews of RCTs.
Cognitive behavioural therapy for insomnia (CBT-I) improves sleep compared with no treatment.
Exercise may improve symptoms compared with no treatment, but evidence is weak.
We don't know whether timed exposure to bright light improves sleep quality compared with no treatment, as we found insufficient evidence.
Clinical context
General background
Insomnia affects up to 40% of older adults. The prevalence increases with age. Primary insomnia is chronic insomnia without specific underlying medical, psychiatric, or other sleep disorders.
Focus of the review
Due to the high prevalence of insomnia in older adults, and the potentially increased risk of sleeping medications in this population, we chose to focus this review on the evidence for non-drug interventions for primary insomnia. In addition, essentially all published guidelines focusing on older adults include that non-drug interventions are recommended as first-line treatment for insomnia.
Comments on evidence
The evidence for effectiveness of cognitive behavioural therapy for insomnia (CBT-I) is convincing, whereas the evidence for exercise programmes and timed exposure to bright light is less clear.
Search and appraisal summary
The update literature search for this review was carried out from the date of the last search, December 2010, to May 2014. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the review, please see the Methods section. After deduplication and removal of conference abstracts, 112 records were screened for inclusion in the review. Appraisal of titles and abstracts led to the exclusion of 92 studies and the further review of 30 full publications. Of the 30 full articles evaluated, four RCTs were added at this update.
Additional information
Although this review focuses on primary insomnia, it is important to mention that, in older adults, insomnia commonly occurs in the presence of other comorbid conditions and that CBT-I is also efficacious in treating such insomnia.
About this condition
Definition
Insomnia is defined in the latest update of the International Classification of Sleep Disorders, third edition (ICSD-3) as repeated difficulty initiating sleep, maintaining sleep, or waking up earlier than desired, which is associated with daytime symptoms and which is not explained purely by inadequate opportunity or circumstances for sleep. Additional types of sleep disturbance and daytime symptoms are included that occur primarily in children. This update of the ICSD also indicates that the sleep disturbance and associated daytime symptoms must occur at least three times per week. The latest update of the Diagnostic and Statistical Manual, fifth edition (DSM-5), defines insomnia disorder as dissatisfaction with sleep quantity or quality associated with difficulty initiating sleep, maintaining sleep, or early-morning awakening, which causes clinically significant distress or impaired functioning, despite adequate opportunity for sleep, and occurs at least 3 nights per week, with some additional criteria. Both ICSD-3 and DSM-5 require a duration of (chronic) insomnia for at least 3 months. Since the ICSD-3 was published in 2014 and the DSM-5 was published in 2013, the studies included in this review generally used earlier versions of these or other definitions for insomnia. Primary insomnia has been defined as chronic insomnia without specific underlying medical, psychiatric, or other sleep disorders, such as sleep apnoea, depression, dementia, periodic limb movement disorder, or circadian rhythm sleep disorder. This review only covers primary insomnia in older people. For this review we define older people as aged 60 years and older (we included studies where at least 80% of participants were recorded as aged 60 years or older).
Incidence/ Prevalence
One population survey in Sweden found that, across all adult age groups, up to 40% of people have insomnia. A US survey in people aged 18 to 79 years found that insomnia affected 35% of all adults during the course of 1 year, and that prevalence increased with age, with estimates ranging from 31% to 38% in people aged 18 to 64 years, to 45% in people aged 65 to 79 years. One US prospective cohort study in people aged over 65 years found that between 23% and 34% had insomnia, and between 7% and 15% had chronic insomnia. It also reported a higher incidence of insomnia in women than in men.
Aetiology/ Risk factors
The cause of insomnia is uncertain. The risk of primary insomnia increases with age and may be related to changes in circadian rhythms associated with age or the onset of chronic conditions and poorer health as a result of ageing. Psychological factors and lifestyle changes may exacerbate perceived effects of changes in sleep patterns associated with age, leading to reduced satisfaction with sleep. Other possible risk factors in all age groups include hyperarousal, chronic stress, and daytime napping.
Prognosis
We found few reliable data on long-term morbidity and mortality in people with primary insomnia. Primary insomnia is a chronic and relapsing condition. Likely consequences include reduced quality of life and increased risk of accidents owing to daytime sleepiness. People with primary insomnia may be at greater risk of dependence on hypnotic medication, depression, dementia, and falls, and may be more likely to require residential care.
Aims of intervention
To improve satisfaction with sleep; to prevent daytime sleepiness and improve functional and cognitive ability during the daytime.
Outcomes
Symptom improvement sleep latency; fragmentation of sleep/number of awakenings; early waking; quality of life; self-report of sleep satisfaction; sleep quality, measured by scales such as the Pittsburgh Sleep Quality Index (PSQI); performance on attentional task tests; daytime functioning measured by scales such as the Stanford Sleepiness Scale and the Epworth Sleepiness Scale; wake after sleep onset (WASO); sleep efficiency. Adverse effects daytime sleepiness during acute phase of treatment.
Methods
BMJ Clinical Evidence search and appraisal May 2014. The following databases were used to identify studies for this systematic review: Medline 1966 to May 2014, Embase 1980 to May 2014, and The Cochrane Database of Systematic Reviews 2014, issue 5 (1966 to date of issue). Additional searches were carried out in the Database of Abstracts of Reviews of Effects (DARE) and the Health Technology Assessment (HTA) database. We also searched for retractions of studies included in the review. Titles and abstracts identified by the initial search, run by an information specialist, were first assessed against predefined criteria by an evidence scanner. Full texts for potentially relevant studies were then assessed against predefined criteria by an evidence analyst. Studies selected for inclusion were discussed with an expert contributor. All data relevant to the review were then extracted by an evidence analyst. Study design criteria for inclusion in this review were published RCTs and systematic reviews of RCTs in the English language, any level of blinding, and containing 20 or more individuals (10 in each arm), of whom more than 80% were followed up. There was no minimum length of follow-up. We included RCTs and systematic reviews of RCTs where harms of an included intervention were assessed, applying the same study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table.
GRADE Evaluation of interventions for Insomnia (primary) in older people: non-drug treatments.
| Important outcomes | Symptom improvement | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of non-drug treatments for primary insomnia in older people (aged 60 years and older)? | |||||||||
| at least 12 (at least 461) | Symptom improvement | CBT-I versus no treatment | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for mixed population (unclear in 1 study; comorbid insomnia in at least 2 others) and range of variants of CBT-I assessed (unclear if all variants equally effective) |
| 2 (95) | Symptom improvement | Exercise versus no treatment | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and for subgroup analysis |
| 1 (61) | Symptom improvement | Timed exposure to bright light versus no treatment | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, poor follow-up, and incomplete reporting of results |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.
Glossary
- Actigraphy
The measurement of body movement used to estimate rest/activity and sleep/wake rhythms over extended periods of time.
- Cognitive behavioural therapy for insomnia (CBT-I)
The following cognitive behavioural therapies for insomnia were considered in this review: stimulus control, sleep hygiene education, muscle relaxation, sleep restriction, cognitive therapies, and behavioural therapy and brief behavioural therapy/treatment. Stimulus control consists of measures to control the stimuli that affect sleep, such as establishing a standard wake up time, getting out of bed during long periods of wakefulness, and eliminating non-nocturnal sleep. Sleep hygiene education informs people about lifestyle modifications that may impair or enhance sleep, such as avoiding alcohol, heavy meals, and exercise before going to bed, and aims to alter expectations about normal sleep durations. Muscle relaxation involves sequential muscle tensing and relaxing. Sleep restriction reduces the time spent in bed to increase the proportion of time spent asleep while in bed. Cognitive therapy for insomnia aims to identify and alter beliefs and expectations about sleep and sleep onset (e.g., beliefs about 'necessary' sleep duration). Cognitive behavioural therapy for insomnia may be undertaken on a one-to-one basis (individual therapy) or with a group of people (group therapy).
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
- Pittsburgh Sleep Quality Index (PSQI)
A validated 21-point scale (0 = best, 21 = worst) to measure subjective sleep quality. A score above 5 indicates insomnia.
- Polysomnography
The electrographic monitoring of sleep using, for example, electroencephalogram (EEG), electromyography (EMG), and respiratory measurements.
- Sleep onset latency
The interval of time between "settling down" to go to sleep and the actual onset of sleep.
- Very low-quality evidence
Any estimate of effect is very uncertain.
- Wake after sleep onset (WASO)
The amount of time spent awake after sleep has been initiated and before final awakening .
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
Contributor Information
Cathy Alessi, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine at UCLA, Los Angeles, US.
Michael V. Vitiello, University of Washington, Seattle, US.
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