• Hypnotic medicines: who, when and how?
• Stepped care approach to stopping
• Educational, behavioural and cognitive therapies for insomnia
• STOP guide for long-term use
• What if hypnotic medicines cannot be stopped?
• NPS Sleep diary
  
• Veterans MATES Therapeutic Brief (external weblink)
• Australasian Sleep Association (external weblink)
• Online Case study: Maximising sleep and minimising potential harms
• Reviewers
  

Hypnotic medicines were prescribed for 95 per 100 insomnia problems encountered in general practice between 2006–08.[1] Benzodiazepines and other related drugs can be avoided by using non-drug therapies. For people who have taken hypnotic medicines long-term, there are strategies to help them stop that can be used in primary care.

Identify and manage contributing factors first

Most people develop insomnia secondary to an identifiable stressor, medical or psychiatric condition, poor sleep practice, medicine or substance use.[2–5] A comprehensive history, examination and/or investigations helps to identify secondary causes: treat and manage these first. Patients can assist in assessing their insomnia by documenting their sleep patterns in a sleep diary.[2,3,5–8]

Use non-drug therapies for insomnia

Non-drug therapies are directed at the physiological, psychological, behavioural and environmental factors that affect sleep.[2] They have comparable efficacy to benzodiazepines and other related drugs.[9–13]

Discuss the benefits of non-drug therapies with patients. Such therapies avoid the adverse effects and dependence of hypnotic medicines, and can improve sleep long after therapy has stopped.

People using the therapies in Box 1 (over 4–8 weeks) fall asleep faster and reduce their time awake after sleep onset by up to 30 minutes more than placebo or no treatment.[9,11,14,15] Improvements can persist for up to 2 years after therapy.[10–12,14] Hypnotic medicines do not provide this long-term benefit.[10–12]

Combine advice on good sleep practices with at least one other therapy — advice alone does not appear to be sufficient for chronic insomnia (present for > 4 weeks).[2,14] Bright light exposure and exercise (not near bedtime) can also help, especially in older people.[7,8,16]

Primary care practitioners can start non-drug therapies or refer patients to a specialist sleep clinic, sleep physician, psychiatrist or psychologist.[5,6,17] Patients can try self-guided therapy (in book, audiovisual or internet formats) but this may not be as effective as face-to-face therapy.[18] The Australian Psychological Society provides an online search tool and referral service to find a suitable psychologist. Members of the Australasian Sleep Association (ASA) who specialise in behavioural and cognitive therapies for insomnia are listed on the ASA website.

For more information about good sleep practices and cognitive and behavioural therapies for insomnia, refer to the materials in Veterans MATES Therapeutic Brief 18.

Hypnotic medicines: who, when and how?

Avoid hypnotic medicine use where possible, especially in older people (see below). Short-term use of a benzodiazepine (e.g. temazepam) or other related drug (zolpidem or zopiclone)[A] may be required for:

• acute insomnia (present for < 4 weeks) if the cause is expected to be short-lived (e.g. grief, noise) and non-drug therapies cannot be implemented readily
• chronic insomnia that has not responded to non-drug therapies alone.[6,19]

Limit use to the shortest time possible: ideally, intermittently (e.g. 2–5 times per week) for < 2 weeks.[2,7,19] Agree up front on a definite duration of therapy with every patient, outlining to them:

• the risk of adverse effects, tolerance and dependence with the medicine
• that long-term use is rarely necessary and is more difficult to stop
• the importance of continuing with non-drug therapies.[2,7,19–21]

Discuss a stopping plan for the hypnotic medicine at the time of the initial prescription. Stopping is more likely to be successful when a shared decision has been made with the patient and there is cooperation from family, carers and staff in aged care facilities.[6,19,22,23]

Ensure that hypnotic medicines prescribed at hospital discharge are not continued unnecessarily: treatment is usually intended to be short-term.

Avoid use in older people

A meta-analysis found that 13 people aged ≥ 60 years need to be treated with a hypnotic medicine for up to a month, instead of placebo, to improve sleep in 1 person — but treating only 6 people leads to an adverse effect, including fatigue, cognitive impairment and serious events involving falls, fractures and motor vehicle accidents.[24]

If drug treatment cannot be avoided, warn patients and their carers about the risk of adverse effects.[19] Long-acting drugs (e.g. diazepam, flunitrazepam, nitrazepam) should not be prescribed in older people as they tend to accumulate and cause excessive sedation.[6,19]

A Zolpidem (Dormizol, Somidem, Stildem, Stilnox, Zolpibell) is not listed on the Pharmaceutical Benefits Scheme; zopiclone (Imovane, Imrest) is available on the RPBS as a restricted benefit.

Stepped care approach to stopping hypnotic medicines

Prolonging treatment with hypnotic medicines (for > 4 weeks) increases the risk of dependence. Most long-term use occurs in older people: while this can be hard to avoid because of co-morbidities or long-standing dependence, there is a case for stopping use in older people as they are at greater risk of harm.[19]

Establish the willingness to stop or reduce use in patients who have been on long-term treatment: Box 2 is a guide to stopping.

Stepwise interventions for helping patients to stop benzodiazepines in primary care include:

1. Brief intervention outlining the need and ways to stop treatment.

2. Systematic intervention involving gradual dose reduction.

3. Augmentation with behavioural and cognitive therapies.[25,26]

Brief intervention can motivate patients to stop

Simple strategies used in general practice and outpatient settings — such as sending a letter advising patients to stop and providing self-help advice — are at least twice as likely to lead to benzodiazepines being stopped than usual care or not raising awareness at all.[25,26]

A systematic intervention can be used if a brief intervention is unsuccessful. Gradual dose reduction guided by a primary care practitioner increases the chance of stopping, which further improves when combined with behavioural and cognitive therapies.[25,26]

There is insufficient evidence for adjunctive drug interventions (e.g. tricyclic antidepressants, carbamazepine) when stopping benzodiazepines.[25–27] Abrupt drug substitution is no better than abruptly stopping the benzodiazepine — gradual dose reduction is more effective.[26]

Gradual dose reduction may still be required after short-term use

Short-term benzodiazepine use (< 2 weeks) at recommended therapeutic doses can usually be stopped abruptly without problem.[19] However, rebound insomnia and other withdrawal symptoms are still possible.[2]

Zolpidem and zopiclone are very short acting and rebound insomnia may also occur on stopping.[2,19,20] A withdrawal syndrome has been reported with zopiclone.[20]

Reassure patients that rebound insomnia usually lasts for only 1–3 days, and does not indicate a need for ongoing treatment.[2,19] If necessary, gradually reduce the dose and/or frequency after short-term use to minimise rebound insomnia and withdrawal symptoms.[2]

Box 1: Educational, behavioural and cognitive therapies for insomnia[2–7,17,19]

Box 2: STOP guide for long-term use of hypnotic medicines[2,6,19–23]

What if hypnotic medicines cannot be stopped?

For patients who have been treated for more than 4–6 months, continued use for insomnia may be acceptable when:

• they are sleeping well and have no adverse effects

• they are aware that they may be unintentionally dependent, and

• attempts to stop treatment are refused or unsuccessful (see Box 2).[19]

People who are unable or unwilling to stop long-term treatment should be offered non-drug strategies that might reduce their need for a hypnotic medicine, and should have regular medication reviews.[19]

Other drugs and herbal medicines? Because of limited evidence and/or the risk of adverse effects, other medicines such as sedating antihistamines, tricyclic antidepressants, melatonin and valerian, are generally not recommended for insomnia.[2,19,20] Antidepressants should only be prescribed for insomnia that coexists with depression.[2,3,21]

Expert reviewers

Communications review group

Dr James Best, General Practitioner, Sydney

A/Prof Nick Buckley, Consultant Clinical Pharmacologist and Toxicologist, University of New South Wales

Jan Donovan, Consumer Representative

Dr John Dowden, Editor, Australian Prescriber

Dr Graham Emblen, General Practitioner, Toowoomba

Deborah Norton, QUM Pharmacist, West Vic DGP

Susan Parker, Pharmacist, Sydney

Dr Jane Robertson, Senior Lecturer, Discipline of Clinical Pharmacology University of Newcastle

Simone Rossi, Managing Editor, Australian Medicines Handbook

Dr Guan Yeo, Clinical Education Consultant and General Practitioner, Berowra

Any correspondence regarding content should be directed to NPS. Declarations of conflicts of interest have been sought from all reviewers. The opinions expressed do not necessarily represent those of the reviewers.

References

1. Charles J, Harrison C, Britt H. Insomnia. Aust Fam Physician 2009;38:283.
2. Schutte-Rodin S, Broch L, Buysse D, et al. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med 2008;4:487–504.
3. Passarella S, Duong M-T. Diagnosis and treatment of insomnia. Am J Health-Syst Pharm 2008;65:927–34.
4. Woodward MC. Managing insomnia in older people. J Pharm Pract Res 2007;37:236–41.
5. Silber MH. Chronic insomnia. N Engl J Med 2005;353:803–10.
6. Australian Government Department of Veteran's Affairs. Veterans’ MATES Therapeutic Brief 18. Insomnia Management: Effective approaches for a common problem. March 2009. https://www.veteransmates.net.au/VeteransMATES/documents/module_materials/M18_TherBrief.pdf (accessed 11 September 2009).
7. Kamel NS, Gammack JK. Insomnia in the elderly: cause, approach, and treatment. Am J Med 2006;119:463–9.
8. Petit L, Azad N, Byszewski A, et al. Non-pharmacological management of primary and secondary insomnia among older people: review of assessment tools and treatments. Age Ageing 2003;32:19–25.
9. Buscemi N, Vandermeer B, Friesen C, et al. Manifestations and Management of Chronic Insomnia in Adults. Evidence Report/Technology Assessment No. 125. Agency for Healthcare Research and Quality (AHRQ) Publication No. 05-E021-2. Rockville, MD: AHRQ. June 2005. http://www.ahrq.gov/downloads/pub/evidence/pdf/insomnia/insomnia.pdf (accessed 6 August 2009).
10. Morin CM, Colecchi C, Stone J, et al. Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial. JAMA 1999;281:991–9.
11. Riemann D, Perlis ML. The treatments of chronic insomnia: a review of benzodiazepine receptor agonists and psychological and behavioral therapies. Sleep Med Rev 2009;13:205–14.
12. Sivertsen B, Omvik S, Pallesen S, et al. Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial. JAMA 2006;295:2851–8.
13. Smith MT, Perlis ML, Park A, et al. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry 2002;159:5–11.
14. Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry 1994;151:1172–80.
15. Montgomery P, Dennis J. Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev 2003;(1):CD003161.
16. Montgomery P, Dennis J. Physical exercise for sleep problems in adults aged 60+. Cochrane Database Syst Rev 2002;(4):CD003404.
17. Harsora P, Kessmann J. Nonpharmacologic management of chronic insomnia. Am Fam Physician 2009;79:125–30.
18. van Straten A, Cuijpers P. Self-help therapy for insomnia: a meta-analysis. Sleep Med Rev 2009;13:61–71.
19. Psychotropic Expert Group. Therapeutic Guidelines: Psychotropic, Version 6. In: eTG complete [CD-ROM]. Melbourne: Therapeutic Guidelines Limited; October 2008.
20. Australian Medicines Handbook, 2009.
21. Tiller JWG. The management of insomnia: an update. Aust Prescr 2003;26:78–81.
22. Khong E, Sim MG, Hulse G. Benzodiazepine dependence. Aust Fam Physician 2004;33:923–6.
23. Lader M, Tylee A, Donoghue J. Withdrawing benzodiazepines in primary care. CNS Drugs 2009;23:19–34.
24. Glass J, Lanctot KL, Herrmann N, et al. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ 2005;331:1169.
25. Voshaar RCO, Couvee JE, van Balkom AJLM, et al. Strategies for discontinuing long-term benzodiazepine use: meta-analysis. Br J Psychiatry 2006;189:213–20.
26. Parr JM, Kavanagh DJ, Cahill L, et al. Effectiveness of current treatment approaches for benzodiazepine discontinuation: a meta-analysis. Addiction 2009;104:13-24.
27. Denis C, Fatseas M, Lavie E, et al. Pharmacological interventions for benzodiazepine mono-dependence management in outpatient settings. Cochrane Database Syst Rev 2006;(3):CD005194.