DSEN Abstract
Comparative effectiveness and safety of pharmacological and non-pharmacological interventions for insomnia: an overview of reviews

*This research was funded by the Drug Safety and Effectiveness Network (DSEN) and conducted by the following investigators: Patricia Rios, Roberta Cardoso, Deanna Morra, Vera Nincic, Zahra Goodarzi, Behara Farah, Sharada Harricharan, Charles M. Morin, Judith Leech, Sharon E Straus, Andrea C Tricco. The statements made herein are those of the stated authors, who are independent researchers.

What is the issue?

  • Insomnia is a common disorder and can contribute to functional impairments, reduced quality of life, cognitive problems and mood disturbances, and may be a risk factor for the onset of mental health disorders
  • Clinical practice guidelines published in the USA, Canada, and Europe recommend non-pharmacological approaches for chronic insomnia (symptoms > 3 months) and pharmacological treatment in acute cases (< 3 months) or as a short-term supplement to non-pharmacological approaches
  • Despite this, the rate of pharmacological use for insomnia has risen over the last 20 years

Summary and Key Messages

  • The rate of prescription sleep aid use has risen despite clinical guidelines endorsing non-pharmacological treatment over pharmacological treatment for insomnia. This review found consistent evidence of effectiveness for both pharmacological and nonpharmacological interventions based on data from moderate to high quality systematic reviews with meta-analysis (SR + MA). Evidence is needed to support the development of guidelines that encourage both the appropriate use of pharmacological interventions to treat insomnia and increasing access to and uptake of nonpharmacological approaches.
  • Cognitive behavioural therapy (CBT) is an effective first-line therapy for adults with insomnia followed by other behavioral interventions, and either can be supplemented with short courses of pharmacological interventions. However, there is no available evidence on the appropriate duration of pharmacological therapy in these reviews. The current results should be interpreted with caution, as many of the included studies that were included in the SRs were low quality, and improvements in the methods used to synthesize knowledge in this field are needed.  

For more information, please contact Dr. Andrea Tricco: Andrea.Tricco@unityhealth.to

What was the aim of the study?

  • To assess the clinical effectiveness and safety of pharmacological and nonpharmacological interventions in adults with insomnia and identify areas where further research or policy development is needed

How was the study conducted?

  • MEDLINE, Embase, PsycINFO, The Cochrane Library, PubMed, and relevant grey literature sites were searched from inception until June 14, 2017
  • Two reviewers independently screened titles/abstracts and full-text articles, and a single reviewer with an independent verifier completed charting, data abstraction, and quality appraisal (AMSTAR 2)
  • No formal statistical analysis was performed as substantial heterogeneity was expected 

What did the study find?

  • Zolpidem, suvorexant, doxepin, and CBT all demonstrated consistent evidence of effectiveness across multiple outcomes reported in more than one high or moderate quality SR+MA
  • Temazepam, triazolam, zopiclone, trazodone, and behavioural interventions all demonstrated consistent evidence of effectiveness across multiple outcomes reported in at least one moderate or high quality SR+MA
  • Evidence gaps in insomnia research include the lack of studies examining potential harms of pharmacological interventions, head-to-head comparisons of pharmacological and non-pharmacological interventions, effects of different doses, and effects of sequencing or combining drug and non-drug interventions
  • Standards that allow researchers to interpret whether a statistically significant change in common measures for insomnia symptoms translates to a clinically significant one are needed  The factors informed the development of 23 recommendations for implementing AU approaches, based on actor and intervention types.

Link to publication: Rios et al, 2019.

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