Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
Sleep latency | |||||
RCT 4-armed trial |
48 people with insomnia aged 60 to 80 years |
Median subjective sleep latency
2 days
43.8 minutes with zaleplon 2 mg 30.0 minutes with zaleplon 5 mg 25.0 minutes with zaleplon 10 mg 45.0 minutes with placebo |
Reported as significant for zaleplon 5 mg and 10 mg only P = 0.654 for zaleplon 2 mg v placebo P = 0.017 for zaleplon 5 mg v placebo P <0.001 for zaleplon 10 mg v placebo |
Effect size not calculated | zaleplon (5 mg and 10 mg only) |
RCT 4-armed trial |
48 people with insomnia aged 60 to 80 years |
Median objective sleep latency
2 days
27.0 minutes with zaleplon 2 mg 23.4 minutes with zaleplon 5 mg 14.6 minutes with zaleplon 10 mg 30.1 minutes with placebo |
P = 0.015 for zaleplon 2 mg v placebo P <0.001 for zaleplon 5 mg v placebo P <0.001 for zaleplon 10 mg v placebo |
Effect size not calculated | zaleplon (2 mg, 5 mg, and 10 mg) |
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective sleep latency in minutes
7 days
with zaleplon 5 mg with zaleplon 10 mg with placebo Absolute results reported graphically |
Reported that zaleplon 10 mg significantly reduced sleep latency compared with placebo; P <0.001 Reported no significant difference for zaleplon 5 mg v placebo |
Effect size not calculated | zaleplon (10 mg only) |
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective sleep latency
14 days
–36.75 minutes with zaleplon 5 mg Reported graphically with zaleplon 10 mg –11.79 minutes with placebo Absolute results reported graphically |
P <0.001 for zaleplon 5 mg or 10 mg v placebo |
Effect size not calculated | zaleplon (5 mg and 10 mg) |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Median subjective sleep latency in minutes
7 and 14 days
with zaleplon 5 mg with zaleplon 10 mg with placebo Absolute numbers not reported |
P <0.001 for zaleplon 5 mg and 10 mg v placebo at either time frame |
Effect size not calculated | zaleplon (5 mg and 10 mg) |
Total sleep time | |||||
RCT 4-armed trial |
48 people with insomnia aged 60 to 80 years |
Median subjective total sleep time
2 days
330.0 minutes with zaleplon 2 mg 330.0 minutes with zaleplon 5 mg 367.5 minutes with zaleplon 10 mg 345.0 minutes with placebo |
P = 0.776 for zaleplon 2 mg v placebo P = 0.140 for zaleplon 5 mg v placebo P = 0.140 for zaleplon 10 mg v placebo |
Not significant | |
RCT 4-armed trial |
48 people with insomnia aged 60 to 80 years |
Median objective sleep duration
2 days
364.6 minutes with zaleplon 2 mg 375.3 minutes with zaleplon 5 mg 365.0 minutes with zaleplon 10 mg 344.6 minutes with placebo |
P = 0.239 for zaleplon 2 mg v placebo P = 0.003 for zaleplon 5 mg v placebo P = 0.030 for zaleplon 10 mg v placebo |
Effect size not calculated | zaleplon (5 mg and 10 mg only) |
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective total sleep time (improvement from baseline)
7 days
Result reported graphically with zaleplon 5 mg 345 (+28.86) minutes with zaleplon 10 mg 318 (+23.48) minutes with placebo |
P <0.05 for zaleplon 10 mg v placebo No significant difference for zaleplon 5 mg v placebo |
Effect size not calculated | zaleplon (10 mg only) |
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective total sleep time (improvement from baseline)
14 days
with zaleplon 5 mg with zaleplon 10 mg with placebo Absolute results reported graphically |
No significant difference for either zaleplon 5 mg or 10 mg v placebo |
Not significant | |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Median subjective total sleep time (improvement from baseline)
7 days
342.0 (+16.3) minutes with zaleplon 5 mg 342.9 (+38.6) minutes with zaleplon 10 mg 346.1 (+24.1) minutes with placebo |
P <0.05 for both zaleplon 5 mg and 10 mg v placebo |
Effect size not calculated | zaleplon (5 mg or 10 mg) |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Median subjective total sleep time (improvement from baseline)
7 days
351.7 (+26.0) minutes with zaleplon 5 mg 351.4 (+47.1) minutes with zaleplon 10 mg 346.1 (+24.1) minutes with placebo |
No significant difference for either zaleplon 5 mg or 10 mg v placebo |
Not significant | |
Subjective sleep quality | |||||
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective sleep-quality score, from 1 = excellent to 7 = poor (improvement from baseline)
7 days
3.83 (+0.46) with zaleplon 5 mg 3.67 (+0.46) with zaleplon 10 mg 4.00 (+0.29) with placebo |
P <0.05 for zaleplon 10 mg v placebo No significant difference for zaleplon 5 mg v placebo |
Effect size not calculated | zaleplon (10 mg only) |
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective sleep-quality score, from 1 = excellent to 7 = poor (improvement from baseline)
14 days
3.75 (+0.54) with zaleplon 5 mg 3.63 (+0.51) with zaleplon 10 mg 4.00 (+0.29) with placebo |
Reported no significant difference for zaleplon 5 mg v placebo |
Not significant | |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Median subjective sleep-quality score, from 1 = excellent to 7 = poor (improvement from baseline)
7 days
3.80 (+0.40) with zaleplon 5 mg 3.80 (+0.50) with zaleplon 10 mg 3.90 (+0.30) with placebo |
P <0.01 for zaleplon 10 mg and 5 mg v placebo |
Effect size not calculated | zaleplon (5 mg and 10 mg) |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Median subjective sleep-quality score, from 1 = excellent to 7 = poor (improvement from baseline)
14 days
3.70 (+0.50) with zaleplon 5 mg 3.80 (+0.50) with zaleplon 10 mg 3.80 (+0.40) with placebo |
P <0.05 for zaleplon 10 mg and 5 mg v placebo |
Effect size not calculated | zaleplon (5 mg and 10 mg) |
Number of awakenings | |||||
RCT 4-armed trial |
48 people with insomnia aged 60 to 80 years |
Median subjective number of awakenings
2 days
3.0 with zaleplon 2 mg 3.0 with zaleplon 5 mg 2.5 with zaleplon 10 mg 2.8 with placebo |
P = 0.671 for zaleplon 2 mg v placebo P = 0.906 for zaleplon 5 mg v placebo P = 0.045 for zaleplon 10 mg v placebo |
Effect size not calculated | zaleplon (10 mg only) |
RCT 4-armed trial |
48 people with insomnia aged 60 to 80 years |
Median objective number of awakenings
2 days
21.0 with zaleplon 2 mg 19.5 with zaleplon 5 mg 18.8 with zaleplon 10 mg 19.5 with placebo |
Not significant for each dose of zaleplon v placebo P = 0.872 for zaleplon 2 mg v placebo P = 0.623 for zaleplon 5 mg v placebo P = 0.969 for zaleplon 10 mg v placebo |
Not significant | |
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective number of awakenings
7 days
1.8 with zaleplon 5 mg 1.8 with zaleplon 10 mg 1.8 with placebo |
No significant difference for either zaleplon 5 mg or 10 mg v placebo |
Not significant | |
RCT 4-armed trial |
549 people with primary insomnia aged 65 years and over |
Median subjective number of awakenings
7 days
1.9 with zaleplon 5 mg 1.7 with zaleplon 10 mg 1.9 with placebo |
No significant difference for either zaleplon 5 mg or 10 mg v placebo |
Not significant | |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Median subjective number of awakenings
7 days
2.0 with zaleplon 5 mg 2.0 with zaleplon 10 mg 2.0 with placebo |
No significant difference for either zaleplon 5 mg or 10 mg v placebo |
Not significant | |
RCT 3-armed trial |
422 people aged 65 years or over with primary insomnia for 3 months or more |
Median subjective number of awakenings
14 days
2.0 with zaleplon 5 mg 1.0 with zaleplon 10 mg 2.0 with placebo |
No significant difference for either zaleplon 5 mg or 10 mg v placebo |
Not significant |