Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
Overall adverse effects | |||||
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Treatment-emergent adverse events
56% with zaleplon 5 mg 59% with zaleplon 10 mg 56% with placebo |
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RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Treatment-emergent adverse effects
68 (48%) with zaleplon 5 mg 59 (50%) with zaleplon 10 mg 74 (51%) with placebo |
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Rebound insomnia | |||||
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective total sleep time (change from baseline)
first night after discontinuing medication
300.00 (–8.57) minutes with zaleplon 10 mg 317.50 (+22.98) minutes with placebo |
P <0.05 for zaleplon 10 mg v placebo |
Effect size not calculated | placebo |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Proportion of people with rebound insomnia
17/136 (13%) with zaleplon 10 mg 6/130 (5%) with placebo |
P = 0.03 for zaleplon 10 mg v placebo |
Effect size not calculated | placebo |