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. 2011 Oct 11;2011:2302.
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