Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits

BMJ 2005; 331 doi: (Published 17 November 2005) Cite this as: BMJ 2005;331:1169
  1. Jennifer Glass, PhD candidate1,
  2. Krista L Lanctôt, scientist, neuroscience research program3,
  3. Nathan Herrmann, head, division of geriatric psychiatry4,
  4. Beth A Sproule, research scientist, division of clinical research2,
  5. Usoa E Busto, head, clinical neuroscience section (usoa_busto{at}
  1. 1University of Toronto, Department of Pharmaceutical Sciences, Toronto, ON, Canada M5S 2S2
  2. 2Centre for Addiction and Mental Health, Toronto, ON, Canada M5S 2S1
  3. 3Department of Psychiatry, University of Toronto, Neuroscience Research Program, Sunnybrook and Women's College Health Sciences Centre, Toronto, ON, Canada M4N 3M5
  4. 4Division of Geriatric Medicine, University of Toronto, Department of Medicine, Sunnybrook and Women's College Health Sciences Centre
  1. Correspondence to: U E Busto
  • Accepted 16 September 2005


Objectives To quantify and compare potential benefits (subjective reports of sleep variables) and risks (adverse events and morning-after psychomotor impairment) of short term treatment with sedative hypnotics in older people with insomnia.

Data sources Medline, Embase, the Cochrane clinical trials database, PubMed, and PsychLit, 1966 to 2003; bibliographies of published reviews and meta-analyses; manufacturers of newer sedative hypnotics (zaleplon, zolpidem, zopiclone) regarding unpublished studies.

Selection criteria Randomised controlled trials of any pharmacological treatment for insomnia for at least five consecutive nights in people aged 60 or over with insomnia and otherwise free of psychiatric or psychological disorders.

Results 24 studies (involving 2417 participants) with extractable data met inclusion and exclusion criteria. Sleep quality improved (effect size 0.14, P < 0.05), total sleep time increased (mean 25.2 minutes, P < 0.001), and the number of night time awakenings decreased (0.63, P < 0.001) with sedative use compared with placebo. Adverse events were more common with sedatives than with placebo: adverse cognitive events were 4.78 times more common (95% confidence interval 1.47 to 15.47, P < 0.01); adverse psychomotor events were 2.61 times more common (1.12 to 6.09, P > 0.05), and reports of daytime fatigue were 3.82 times more common (1.88 to 7.80, P < 0.001) in people using any sedative compared with placebo.

Conclusions Improvements in sleep with sedative use are statistically significant, but the magnitude of effect is small. The increased risk of adverse events is statistically significant and potentially clinically relevant in older people at risk of falls and cognitive impairment. In people over 60, the benefits of these drugs may not justify the increased risk, particularly if the patient has additional risk factors for cognitive or psychomotor adverse events.


  • Contributors JG wrote the protocol with input from all authors, did the initial searches and study selection, data abstraction, and data analyses including graphics, and wrote the paper. She is guarantor. UEB helped write the protocol and establish the inclusion and exclusion criteria, evaluated study quality, carried out data abstraction, and edited the final manuscript. KLL helped write the protocol, assisted and reviewed data analyses and statistical analyses, graphing, and interpretation of results, and edited the final report. NH helped write the protocol, gave clinical input into the study design, inclusion and exclusion criteria, evaluated study quality, and edited the final manuscript. BAS provided input on the protocol, including clinical input, commented on interim results, and reviewed and edited results (including graphs and tables) and the final manuscript

  • Funding This study was part of a PhD thesis for JG

  • Competing interests None declared.

  • Ethical approval Not required

  • Accepted 16 September 2005
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