Non-pharmacological methods should be initiated before pharmacotherapy in the management of this common condition, explains Professor Kevin Morgan

The commonest psychological symptom in Britain is ‘sleep disturbance’, with around one-third of women and one-quarter of men reporting that they have sleep problems.1 Sleep disturbances fulfil the criteria for insomnia when they become chronic and are accompanied by daytime consequences. The prevalence of insomnia is 9–15% in the adult population,2 and increases with age: from 5–10% of individuals aged 18–25 years to around 30% of those aged 65 years and over.2 At all ages, women generally report higher rates of insomnia than men.2 Insomnia risk is also greatly elevated among individuals with long-term health conditions,3 and those providing care at home for a dependent relative or spouse.4

While data are scarce, the General Practice Research Database suggests an incidence of all sleep disorder diagnoses of 12.5 per 1000 person-years.5 If non-insomnia sleep disorders are excluded (e.g. obstructive sleep apnoea, restless leg syndrome, narcolepsy), diagnoses of insomnia probably account for at least half of these cases.

Diagnosis

Within current diagnostic systems,6,7 insomnia is characterised by a complaint of difficulty initiating or maintaining sleep, or of non-restorative sleep, despite adequate opportunities to sleep. These difficulties occur three or more times per week, persist for at least a month, and are associated with impaired daytime functioning.6,7

Most people with insomnia report symptoms of daytime fatigue, but few (approximately 20–25%) report
symptoms of daytime sleepiness
(i.e. increased daytime sleep tendency).8 Other daytime symptoms typically include mood disturbances and impaired concentration.8 Given the emphasis on symptom duration (?4 weeks), all insomnias can be considered chronic.

Cause of insomnia

Research evidence supports the view that insomnia results from the interaction of:9

  • predisposing factors—inherent psychological vulnerability characterised by higher levels of trait anxiety, susceptibility to cognitive intrusions prior to sleep, and attentional bias towards the consequences of sleep
  • precipitating factors—physical, psychological, or situational events that disturb sleep
  • perpetuating factors—maladaptive behavioural responses to sleep disturbance which, over time, maintain insomnia as a chronic problem.

This interactive model helps to explain why some precipitating events (e.g. occupational stress, illness, childbirth, bereavement) can disturb sleep in most individuals, but produce chronic insomnia in only a minority (the predisposed). It also recognises that behavioural (perpetuating) factors can maintain insomnia symptoms long after the precipitating factors have been resolved.

The construct of ‘secondary insomnia’ (where the sleep disorder is presumed to result directly from a current physical or psychological disorder) has proved to be problematic. Review evidence indicates that causality in ‘secondary’ insomnias can rarely be established, and that both primary (where there is no co-morbidity) and ‘co-morbid’ (the now preferred term) insomnias share common perpetuating factors that respond to the same treatment approaches.10

Impact of insomnia

Insomnia is associated with a lower quality of life, impaired social and occupational functioning, delayed recovery from acute illness episodes, and increased healthcare utilisation,11 and is an independent risk factor for major depression.12 Detailed Canadian estimates taking into account both direct costs (from healthcare utilisation and treatments) and indirect costs (from absenteeism and productivity losses) highlight the financial impact of this condition: the annual economic burden per individual meeting the criteria for insomnia is nearly 12 times higher compared with good sleepers ($5010 per year versus $421 per year, respectively). The greatest proportion of this burden (76%) was found in reduced work attendance and performance.13

In addition to representing a direct cost, hypnotic drugs, the principal treatment option for insomnia in primary care, are also associated with indirect costs arising from a range of adverse effects including:9,14,15

  • residual sedation
  • cognitive impairment
  • daytime anxiety
  • tolerance
  • dependence
  • road traffic accidents
  • falls and hip fractures (in older users).

Treatment

Evidence-based NHS treatments for insomnia include:

  • non-pharmacological approaches, collectively referred to as cognitive behavioural therapy for insomnia (CBT-I)
  • sedative hypnotic drugs (older benzodiazepines and newer ‘Z-drugs’)
  • prolonged-release melatonin (limited to primary insomnia among those aged 55 years and over).15

Cognitive behavioural therapy

Following a sleep assessment (including a sleep diary), the four main components of CBT-I comprise:

  • sleep hygiene16
  • stimulus control (reducing the time spent in bed awake) and sleep restriction (increasing ‘appropriate’ night-time sleepiness by limiting the opportunity to sleep)14
  • relaxation (physical relaxation strategies)14
  • cognitive therapy (controlling pre-sleep thoughts).14

Experience has shown that cognitive behavioural therapy for insomnia can be effectively delivered by appropriately trained members of the primary care team (e.g. counsellors, health visitors, practice nurses, psychologists).14,17

Drug treatment should be considered only for patients who fail to show significant improvement following CBT-I, and where the sleep problems remain ‘severe, disabling, or subjecting the individual to extreme distress’.18

Treatment pathway

The broader issue of insomnia management in primary care has often been eclipsed by (or mistaken for) the important, but narrower, issue of appropriate hypnotic drug use. The NICE technology appraisal on the use of zaleplon, zolpidem, and zopiclone for the short-term management of insomnia, published in 2004, follows this general trend.19 Nevertheless, when augmented by insomnia-relevant contributions from the NICE clinical guideline on the management of depression,20 and the National Service Framework for Older People21 and Mental Health,22 the appraisal supplies the key recommendations for an evidence-based approach to insomnia management. These recommendations are outlined in Box 1 and summarised in Figure 1 as a stepped-care model.

While the NICE technology appraisal does not explicitly identify key treatment outcomes, clinical trials suggest five treatment aims valued by patients:23

  • improved subjective sleep quality
  • reduced sleep latencies
  • reduced sleep fragmentation
  • optimised daytime (occupational and social) functioning
  • improved quality of life.

Box 1: Management of insomnia

  1. Before commencing treatment, ensure the sleep problem meets chronicity and severity criteria for insomnia. Sleep disturbances arising from episodic homeostatic (as in occupational sleep loss) or circadian (as in jet-lag) challenges should be given time to self-correct before treatment (beyond sleep hygiene advice) is initiated.

  2. The appropriate management of co-morbidity is essential, but may not resolve the accompanying sleep problem.19

  3. The provision of sleep hygiene advice is ‘...fundamental to the overall management strategy.’19 As the advice targets ‘problem’ behaviours (caffeine consumption, irregular sleep habits, etc) some prior assessment of lifestyle is appropriate.

  4. Cognitive behavioural therapy for insomnia (including relaxation treatments) has been shown to be effective, and should be considered before hypnotic drugs are prescribed.

  5. If patients do not respond to non-pharmacological treatments (or if these treatments are unavailable), hypnotics should be prescribed for short periods only, in strict accordance with their licensed indications.19

  6. ‘Because of the lack of compelling evidence to distinguish between zaleplon, zolpidem, zopiclone, or the shorter-acting benzodiazepine hypnotics, the drug with the lowest purchase cost... should be prescribed.’19

  7. Switching from one hypnotic drug to another should only occur if a patient experiences adverse effects that are believed to be directly related to a specific agent.

  8. Patients who have not responded to one hypnotic drug should not be prescribed another.

  9. Hypnotic drug use should not be continued beyond 4 weeks (or beyond 2 weeks for zaleplon).

  10. All patients who feel unable or unwilling to discontinue hypnotic drug use should be given withdrawal support.*
*The National Service Framework for Older People states that support should be provided by PCTs to help older patients ‘come off’ hypnotics;21 cognitive behavioural therapy for insomnia has also been shown to be effective in promoting drug reduction and withdrawal in younger and older adults14

Figure 1: A stepped-care model for management of primary and co-morbid insomnia in primary care

figure 1

IAPT=improving access to psychological therapies

*As defined in: Department of Health. Improving access to psychological therapies–Implementation plan: national guidelines for regional delivery. London: DH, 2008. Available from www.iapt.nhs.uk

**Appropriately trained in cognitive behavioural therapy for insomnia

NB Steps are based on NICE guidance and NSF recommendations;19-21 the model is suitable for new cases of primary and co-morbid insomnia. When combined with tapered drug withdrawal, long-term hypnotic drugs users may be offered steps 1 to 4.

Conclusion

Despite the useful contribution of the NICE technology appraisal on the use of zaleplon, zolpidem, and zopiclone, the needs of patients and healthcare professionals would be better served if a full range of insomnia treatment options (which should include sleep hygiene and CBT) were more widely available in primary care. To this end, the review of the NICE hypnotic drug guidance, scheduled for April 2010, could usefully appraise a broader range of insomnia management approaches, both pharmacological (with recommendations on the use of melatonin) and non-pharmacological.

Key Points

  • The patient should be assessed to determine if their sleep problem fulfils the criteria for insomnia
  • Any co-morbidity should be managed appropriately
  • Sleep hygiene advice is fundamental to management and must be provided
  • Cognitive behavioural therapy for insomnia should be considered before a pharmacological approach
  • Hypnotic drugs should be prescribed in strict accordance with their licensed indications and for short periods only
  • The drug with the lowest purchase cost should be prescribed
  • Withdrawal support should be available for those patients who are unable or unwilling to discontinue hypnotic drug use

Click here for CPD questions on this article and guidance on insomnia
  • Psychological therapies should be tried before pharmacological therapies
  • The new IAPT programme, which is being implemented nationally, outlines a series of effective ‘talking therapies’
  • Practice-based commissioning groups should be actively involved in local IAPT-implementation programmes and help shape them locally to their population needs
  • Front-line primary healthcare professionals can be trained to deliver ‘low intensity interventions’
  • Cognitive behavioural therapy should be commissioned, and be made available locally under the IAPT programme
  • Mental health services are likely to be included in the PbR tariff from 1 April 2010

IAPT=improving access to psychological therapies; PbR=payment by results

  1. Singleton N, Bumpstead R, O’Brien M et al. Psychiatric morbidity among adults living in private households, 2000. London: The Stationery Office, 2001.
  2. Ohayon M. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev 2002; 6 (2): 97–111.
  3. Foley D, Ancoli-Israel S, Britz P, Walsh J. Sleep disturbances and chronic disease in older adults: results of the 2003 National Sleep Foundation Sleep in America Survey. J Psychosom Res 2004; 56 (5): 497–502.
  4. Maher J, Green H. Carers 2000. London: The Stationery Office, 2002.
  5. Wallander M, Johansson S, Ruigómez A et al. Morbidity associated with sleep disorders in primary care: a longitudinal cohort study. Prim Care Companion J Clin Psychiatry 2007; 9 (5): 338–345.
  6. American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-IV). 4th edn. Washington (DC): American Psychiatric Association, 1994.
  7. American Academy of Sleep Medicine. International classification of sleep disorders: Diagnostic and coding manual, 2nd edn. Westchester, IL: American Academy of Sleep Medicine, 2005: 177–220.
  8. Sateia M, Nowell P. Insomnia. Lancet 2004; 364 (9449): 1959–1973.
  9. Spielman A, Caruso L, Glovinsky P. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am 1987; 10 (4): 541–553.
  10. National Institutes of Health. National Institutes of Health state of the science: Conference statement on manifestations and management of chronic insomnia in adults, June 13–15, 2005. Sleep 2005; 28 (9): 1049–1057.
  11. Buscemi N, Vandermeer B, Friesen C et al. Evidence Report/Technology Assessment No. 125: Manifestations and management of chronic insomnia in adults. Rockville, MD: Agency For Healthcare Research and Quality, 2005.
  12. Riemann D, Voderholzer U. Primary insomnia: a risk factor to develop depression? J Affect Disord 2003; 76 (1–3): 255–259.
  13. Daley M, Morin C, LeBlanc M et al. The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms and good sleepers. Sleep; In Press. www.journalsleep.org/AcceptedPapers/SP0056607.pdf
  14. Morgan K, Dixon S, Mathers N et al. Psychological treatment for insomnia in the regulation of long-term hypnotic drug use. Health Technol Assess 2004; 8 (8): iii–iv, 1–68.
  15. British National Formulary. BNF 56. London: Royal Pharmaceutical Society, 2008.
  16. Richards D, Whyte M. Reach Out: national programme educator materials to support delivery of training for practitioners delivering low intensity interventions. London: IAPT, 2008. www.iapt.nhs.uk/wp-content/uploads/2008/07/0725_teaching-manual-18july.pdf
  17. Espie C, Inglis S, Tessier S, Harvey L. The clinical effectiveness of cognitive behaviour therapy for chronic insomnia: implementation and evaluation of a sleep clinic in general medical practice. Behav Res Ther 2001; 39 (1): 45–60.
  18. Committee on Safety of Medicines. Benzodiazepines, dependence and withdrawal symptoms. Current Problems 1988; 21: 1–2.
  19. National Institute for Clinical Excellence. Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia. Technology Appraisal 77. London: NICE, 2004.
  20. National Institute for Clinical Excellence. Depression: management of depression in primary and secondary care. National Clinical Practice Guideline 23. London: The British Society and Gaskell, 2004.
  21. Department of Health. Medicines and older people: implementing medicines-related aspects of the NSF for older people. London: DH, 2001.
  22. Department of Health. National Service Framework for Mental Health: modern standards and service models. London: DH, 2001.
  23. Buysse D, Ancoli-Israel S, Edinger J et al. Recommendations for a standard research assessment of insomnia. Sleep 2006; 29 (9): 1155–1173.G