- Design
- Systematic review and meta-analysis of RCTs and observational studies
- Population
- 19 studies, 183,595 participants using or not using orexin antagonists
- Primary outcome
- Falls and fractures
- Effect
- Falls OR 0.76 (95% CI 0.56 to 1.04); fractures OR 1.05 (0.94 to 1.18)
This systematic review and meta-analysis, published in September, included 19 studies (10 randomised trials and 9 observational studies, 183,595 participants) comparing falls and fractures in people taking dual orexin receptor antagonists for insomnia with non-users.
Overall, these drugs were not associated with more falls (OR 0.76, 95% CI 0.56 to 1.04) or fractures (OR 1.05, 0.94 to 1.18). In the randomised trials alone, falls were less frequent (OR 0.59, 0.35 to 0.98), but this was not seen in observational studies.
The authors stress caution: events were few, the analysis did not reach the number of events needed to detect a clinically meaningful difference, and data specifically in older adults were limited. The study compares users with non-users, not with benzodiazepines or Z-drugs directly.
Where a hypnotic is genuinely needed in an older adult after behavioural treatment, this class may be a less risky option than benzodiazepines or Z-drugs, but it is not proven safe. Availability and cost in India vary by agent and should be checked.
- Offer cognitive behavioural therapy for insomnia first in older adults.
- If a hypnotic is needed, consider an orexin antagonist over a benzodiazepine or Z-drug.
- Continue to assess falls risk in anyone starting a hypnotic of any class.
- Do not describe orexin antagonists as fall-free; data in older adults are limited.
- Review the need for any hypnotic at each follow-up.
Why it matters
Clinicians need a hypnotic option that does not trade sleep for a hip fracture, and this is the best evidence so far for one class.
Don't overread it
The analysis was underpowered for falls, compared users with non-users rather than with other hypnotics, and had limited data in older adults.
The statistics, in plain English
An odds ratio of 0.76 with an interval reaching 1.04 means no clear increase or decrease in falls overall. The randomised-trial result of 0.59 suggests fewer falls but rests on few events. Not reaching the optimal information size means the analysis may be underpowered.
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