Table 2.
Study Characteristics for Trials Comparing Non-benzodiazepines and Placebo in Adults with Chronic Insomnia
| First Author/Year | Sample Size, n enrolled | Mean age ± SD or (range), in years | Number of Females/Males or (Percentage Female/Male) | Psychiatric Illness | Quality Score (Jadad) | Intervention | ||
|---|---|---|---|---|---|---|---|---|
| Drug | Dose, mg | Duration | ||||||
| Allain H/1998* | 84 | 54.3 ± 11.0 | NS (67.9/32.1) | NS | 4 | Triazolam; zolpidem | 0.125; 10 | 4 nights |
| Allain H/2001 | 245 | Zolpidem: 45.6 ± 9.6, PL: 46.7 ± 11.5 | 188/57 | NS | 3 | Zolpidem | 10 | 4 weeks |
| Asnis GM/1999 | 273 | Zolpidem: 41.6 ± 1.2, PL: 41.6 ± 1.0 | 150/40 | Various psychiatric conditions | 3 | Zolpidem | 10 | 4 weeks |
| Campbell RD/1987 | 71 | 38 ± 2 | 25/31 | NS | 4 | Flurazepam; zopiclone | 30; 7.5 | 3 weeks for each TR |
| Chaudoir PJ/1983 | 30 | 50 ± NS (35–65) | 18/7 | NS | 3 | Zopiclone | 7.5 | 7 nights |
| Deacon S/2005* | 26 | NS (18–65) | NS | NS | 3 | Gaboxadol | 5; 15 | 6 nights |
| Declerk A/1999 | 22 | 54 ± NS (NS) | 17/5 | NS | 3 | Zolpidem | 10 | 1 week |
| Drake CL/2000 | 93 | Study 1: 41.6 ± 9.5, study 2: 38.1 ± 11.1 | 38/45 | NS | 4 | Zaleplon; triazolam | Study 1: 10, 40; 0.25, study 2: 20, 60; 0.25 | 2 nights for each TR |
| Dujardin K/1998* | 12 | NS (40–62) | 0/12 | NS | 3 | Zolpidem; flunitrazepam | 10; 1 | 3 weeks |
| Elie R/1990* | 44 | 76 ± 1.3 | 33/11 | NS | 3 | Zopiclone; triazolam | 5, 7.5; 0.125, 0.25 | 3 weeks |
| Elie R/1999 | 615 | 5 mg zaleplon: 42.5 ± 12.9, 10 mg zaleplon: 42.6 ± 12.5, 20 mg zaleplon: 42.6 ± 12.2, 10 mg zolpidem: 44.3 ± 12.5, PL: 42.1 ± 12.0 | 370/204 | NS | 3 | Zaleplon; zolpidem | 5, 10, 20; 10 | 4 weeks |
| Farber R/2006* | 702 | 46 ± NS | 428/274 | NS | 2 | Indiplon | 10; 20 | 3 months |
| Fleming J/1995 | 144 | 33–37 ± NS†(21–60) | NS (48/52) | NS | 3 | Zolpidem; flurazepam | 10, 20; 30 | 3 nights |
| Fry J/2000 | 595 | 5 mg zaleplon: 43 ± 12, 10 mg zaleplon: 40 ± 10, 20 mg zaleplon: 41 ± 13, 10 mg zolpidem: 42 ± 11, PL: 43 ± 12 | 342/244 | NS | 3 | Zaleplon; zolpidem | 5, 10, 20; 10 | 28 nights |
| Gelinas B/1985* | 32 | 40.9 ± 2.19 | 16/10 | NS | 4 | Zopiclone | 7.5 | 3 weeks |
| Goldenberg F/1994 | 524 | Zopiclone: 42.5 ± 8.6; PL: 43.3 ± 9.2 | 291/167 | NS | 4 | Zopiclone | 7.5 | 14 nights—as needed for 4 weeks |
| Hajak G/1994‡ | 1,507 | 51 ± 11 | 939/566 | NS | 5 | Zopiclone; flunitrazepamtriazolam | 7.5; 1.0; 0.25 | 28 days |
| Hedner J/2000 | 437 | 5 mg zaleplon: 72.5 ± 5.9, 10 mg zaleplon: 72.5 ± 6.3, Pl: 72.5 ± 6.8 | 285/137 | NS | 3 | Zaleplon | 5, 10 | 2 weeks |
| Hermann WM/1993 | 25 | NS (25–65) | 9/12 | NS | 3 | Zolpidem | 10 | 2 weeks |
| Jacobs GD/2004* | 63 | TR: 45.4 ± 9.3, PL: 46.6 ± 10.1 (25–64) | 44/19 | NS | 3 | Zolpidem | 10 × 28 nights; 5 × 14 nights | 6 weeks |
| Krystal AD/2003 | 788 | 44 ± 11 | 498/290 | NS | 3 | Eszopiclone | 3 | 6 months |
| Lahmeyer, H/1997 | 178 | 44.9 ± NS (19–61) | 81/64 | NS | 4 | Zolpidem | 10, 15 | 31 nights |
| Lamphere JK/1989* | 12 | 36 ± 10 | 3/9 | NS | 2 | Zopiclone | 2.5, 5.0, 7.5, 10, 15 | 6 weeks |
| Lankford J/2005* | 229 | NS (65–85) | NS | NS | 2 | Indiplon | 15 | 2 weeks |
| Leppik IE/1997 | 457 | 69 ± NS (59–85) | NS (63/37) | NS | 3 | Zolpidem; triazolam; temazepam | 5; 0.125; 15 | 4 weeks |
| Mamelak M/1987* | 30 | 50 ± NS (32–60) | 21/9 | NS | 4 | Flurazepam; zopiclone | 30; 7.5 | 12 days |
| Monchesky TC/1986* | 99 | Zopiclone: 47.1 ± 1.7, PL: 46.6 ± 1.8 | 65/26 | NS | 4 | Zopiclone | 7.5 | 4 weeks |
| Monti JM/1996* | 12 | Zolpidem: 41.2 ± 3.9, PL: 47.3 ± 5.7 | 10/2 | NS | 3 | Zolpidem | 10 | 27 nights |
| Monti JM/2000* | 12 | Zolpidem: 53.8 ± 1.8, Pl: 50.0 ± 5.3 | 12/0 | NS | 3 | Zolpidem | 10 | 15 nights |
| Nair NPV/1990‡ | 60 | 46.9 ± 1.4 | 28/32 | NS | 3 | Zopiclone; flurazepam | 3.75, 7.5, 11.25, 15, 30 | 7 days |
| Perlis ML/2004* | 199 | 41.0 ± 12.8 (18–64) | 141/58 | NS | 3 | Zolpidem | 10 | 12 weeks |
| Scharf MB/1994 | 75 | 38 ± NS (22–60) | 48/27 | NS | 3 | Zolpidem | 10, 15 | 5 weeks |
| Scharf M/2005 | 231 | 72.3 ± 4.9 (65–85) | 133/98 | NS | 2 | Eszopiclone | 1; 2 | 2 weeks |
| Schnitzer T/2005 | 153 | TR: 52.3 ± 8.1, PL: 51.8 ± 9.5 | 133/20 | NS | 3 | Eszopiclone | 3 | 4 weeks |
| Shaw SH/1992‡ | 119 | 10 mg zolpidem: 74.9 ± 1.0, 20 mg zolpidem: 72.9 ± 1.0, PL: 75.7 ± 0.8 | 81/38 | Various psychiatric conditions | 3 | Zolpidem | 10, 20 | 21 days |
| Sivertsen B/200648 | 48 | 60.8 ± 5.4 | 22/24 | NS | 4 | Zopiclone | 7.5 | 6 weeks |
| Soares CN/2005 | 410 | TR: 49.3 ± 4.1, PL: 48.9 ± 3.9 (40–60) | 410/0 | NS | 3 | Eszopiclone | 3 | 4 weeks |
| Staner L/2005* | 23 | 38.8 ± 2.0 | 14/9 | NS | 2 | Zolpidem; zopiclone; lormetazepam | 10; 7.5; 1 | 8 nights |
| Steens RD/1993* | 24 | 58.2 ± 5.5 | 9/15 | NS | 3 | Zolpidem; triazolam | 5, 10; 0.25 | 1 night for each TR |
| Stip E/1999* | 60 | 42.6 ± 1.6 | 21/29 | NS | 4 | Zopiclone; temazepam | 7.5; 30 | 3 weeks |
| Walsh JK/1998 | 132 | 5 mg zaleplon: 38.9 ± 10.3, 10 mg zaleplon: 39.6 ± 10.0, triazolam: 39.3 ± 11.7 | 77/55 | NS | 4 | Zaleplon; triazolam | 5, 10; 0.25 | 14 nights |
| Walsh JK/1998 | 589 | 42 ± NS (21–65) | 193/85 | NS | 3 | Zolpidem; trazodone | 10; 50 | 14 nights |
| Walsh JK/2000* | 54 | 67.5 ± NS (60–79) | 17/31 | NS | 3 | Zaleplon | 2, 5, 10 | 2 nights |
| Walsh JK/ 2000* | 163 | Zolpidem: 43.2 ± 1.2, PL: 45.0 ± 1.3 | 115/48 | NS | 4 | Zolpidem | 10 | 8 weeks |
| Walsh JK/2002* | 365 | Zolpidem: 43.2 ± 1.2, PL: 45.0 ± 1.3 | 115/48 | NS | 3 | Zolpidem | 10 | 4 weeks |
| Walsh JK/2004* | 194 | 40.2 ± 11.8 | 128/66 | NS | 2 | Indiplon | 10; 20 | 5 weeks |
| Walsh JK/2005 | 358 | NS (65–80) | NS | NS | 2 | Indiplon | 5; 10 | 2 weeks |
| Zammit GK/2004 | 308 | TR 2 mg: 40.6 ± 11.5, TR 3 mg: 38 ± 11.7, PL: 40.8 ± 11.8 (21–64) | 199/109 | NS | 3 | Eszopiclone | 3; 3 | 44 nights |