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. 2007 Oct 1;2007:2302.

Table 1.

RCTs comparing different doses of zaleplon versus placebo for the treatment of insomnia in elderly people.

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.