Table 1.
Ref | Participants | Intervention and comparison | Results |
Median subjective sleep latency in minutes | |||
48 people with insomnia, aged 60–80 years | Zaleplon 2, 5, and 10 mg v placebo | At 2 days: 43.8 with zaleplon 2 mg v 45.0 with placebo; P = 0.654 30.0 with zaleplon 5 mg v 45.0 with placebo; P = 0.017 25.0 with zaleplon 10 mg v 45.0 with placebo; P less than 0.001 | |
549 people with primary insomnia aged 65 years and over | Zaleplon 5 and 10 mg v placebo | At 7 days: Improvement from baseline in both zaleplon 5 mg and placebo group; data presented graphically; reported as NS At 14 days: –36.75 with zaleplon 5 mg v –11.79 with placebo; P less than 0.001 At 7 and 14 days: zaleplon 10 mg > placebo; data presented graphically; P less than 0.001 | |
422 people aged 65 years or over with primary insomnia for 3 months or more | Zaleplon 5 and 10 mg v placebo | At 7 and 14 days: zaleplon 5 and 10 mg > placebo; data presented graphically; P less than 0.001 | |
Median objective sleep latency in minutes | |||
48 people with insomnia, aged 60–80 years | Zaleplon 2, 5, and 10 mg v placebo | At 2 days: 27.0 with zaleplon 2 mg v 30.1 with placebo; P = 0.015 23.4 with zaleplon 5 mg v 30.1 with placebo; P less than 0.001 14.6 with zaleplon 10 mg v 30.1 with placebo; P less than 0.001 | |
Median subjective total sleep time in minutes (improvement from baseline) | |||
48 people with insomnia, aged 60–80 years | Zaleplon 2, 5, and 10 mg v placebo | At 2 days: 330.0 with zaleplon 2 mg v 345.0 with placebo; P = 0.776 350.0 with zaleplon 5 mg v 345.0 with placebo; P = 0.140 367.5 with zaleplon 10 mg v 345.0 with placebo; P = 0.011 | |
549 people with primary insomnia aged 65 years and over | Zaleplon 5 and 10 mg v placebo | At 7 and 14 days: Subjective improvement in both zaleplon 5 mg and placebo groups from baseline presented graphically; NS At 7 days: 345 (+28.86) with zaleplon 10 mg v 318 (+23.48) with placebo; P less than 0.05 At 14 days: Subjective improvement in both zaleplon 10 mg and placebo groups from baseline presented graphically; NS | |
422 people aged 65 years and over with primary insomnia for 3 months or more | Zaleplon 5 and 10 mg v placebo | At 7 days: 342.0 (+16.3) with zaleplon 5 mg v 346.1 (+24.1) with placebo; P less than 0.05 At 14 days: 351.7 (+26.0) with zaleplon 5 mg v 342.9 (+20.9) with placebo; NS At 7 days: 342.9 (+38.6) with zaleplon 10 mg v 346.1 (+24.1) with placebo; P less than 0.05 At 14 days: 351.4 (+47.1) with zaleplon 10 mg v 342.9 (+20.9) with placebo; NS | |
Median objective sleep duration in minutes | |||
48 people with insomnia, aged 60–80 years | Zaleplon 2, 5, and 10 mg v placebo | At 2 days: 364.6 with zaleplon 2 mg v 344.6 with placebo; P = 0.239 375.3 with zaleplon 5 mg v 344.6 with placebo; P = 0.003 365.0 with zaleplon 10 mg v 344.6 with placebo; P = 0.030 | |
Median subjective sleep quality score* (improvement from baseline) | |||
549 people with primary insomnia aged 65 years or over | Zaleplon 5 and 10 mg v placebo | At 7 days: 3.83 (+0.46) with zaleplon 5 mg v 4.00 (+0.29) with placebo; NS At 14 days: 3.75 (+0.54) with zaleplon 5 mg v 4.00 (+0.29) with placebo; NS At 7 days: 3.67 (+0.46) with zaleplon 10 mg v 4.00 (+0.29) with placebo; P less than 0.05 At 14 days: 3.63 (+0.51) with zaleplon 10 mg v 4.00 (+0.29) with placebo; NS | |
422 people aged 65 or over with primary insomnia for 3 months or more | Zaleplon 5 and 10 mg v placebo | At 7 days: 3.80 (+0.40) with zaleplon 5 mg v 3.90 (+0.30) with placebo; P less than 0.01 At 14 days: 3.70 (+0.50) with zaleplon 5 mg v 3.80 (+0.40) with placebo; P less than 0.05 At 7 days: 3.80 (+0.50) with zaleplon 10 mg v 3.90 (+0.30) with placebo; P less than 0.01 At 14 days: 3.70 (+0.60) with zaleplon 10 mg v 3.80 (+0.40) with placebo; P less than 0.05 | |
Median subjective number of awakenings | |||
48 people with insomnia, aged 60–80 years | Zaleplon 2, 5, and 10 mg v placebo | At 2 days: 3.0 with zaleplon 2 mg v 2.8 with placebo; P = 0.671 3.0 with zaleplon 5 mg v 2.8 with placebo; P = 0.906 2.5 with zaleplon 10 mg v 2.8 with placebo; P = 0.045 | |
549 people with primary insomnia aged 65 years or over | Zaleplon 5 and 10 mg v placebo | At 7 days: 1.8 with zaleplon 5 mg v 2.0 with placebo; NS At 14 days: 1.9 with zaleplon 5 mg v 1.9 with placebo; NS At 7 days: 1.8 with zaleplon 10 mg v 2.0 with placebo; NS At 14 days: 1.7 with zaleplon 10 mg v 1.9 with placebo; NS | |
422 people aged 65 years or over with primary insomnia for 3 months or more | Zaleplon 5 and 10 mg v placebo | At 7 days: 2.0 with zaleplon 5 mg v 2.0 with placebo; NS At 14 days: 2.0 with zaleplon 5 mg v 2.0 with placebo; P less than 0.05 At 7 days: 2.0 with zaleplon 10 mg v 2.0 with placebo; NS At 14 days: 2.0 with zaleplon 10 mg v 1.0 with placebo; NS | |
Median objective number of awakenings | |||
48 people with insomnia, aged 60–80 years | Zaleplon 2, 5, and 10 mg v placebo | At 2 days: 21.0 with zaleplon 2 mg v 19.5 with placebo; P = 0.872 19.5 with zaleplon 5 mg v 19.5 with placebo; P = 0.623 18.8 with zaleplon 10 mg v 19.5 with placebo; P = 0.969 |
NS, not significant; SL, median sleep latency; TST, median total sleep time; >, favours treatment; <, favours placebo. * Scale: 1 = excellent; 2 = very good; 3 = good; 4 = fair; 5 = poor; 6 = very poor; 7 = extremely poor.