| Author | Year | Population | Sample Size | N | Study Design | Intervention | |
|---|---|---|---|---|---|---|---|
| Almeida-Montes, LG | 2003 | Age (Years) | Treatment Group | RCT | Formulation | ||
| Quality Score | 16 | Mean (SD): | 50 (NS) | Enrolled: | 10 | Double-blind | Sustained-release MLT |
| Range: | 30–72 | Analyzed: | 10 | Cross-over | Route of Administration | ||
| Gender | Control Group | Oral | |||||
| Female: | 4 | Enrolled: | 10 | Dosage and Timing | |||
| Male: | 6 | Analyzed: | 10 | 0.3 mg or 1 mg of MLT 1h before bedtime | |||
| Ethnicity: NS | Frequency and Duration | ||||||
| Sleep Disorder: Insomnia | One dose/day for 14 days | ||||||
| Garfinkel, D | 1995 | Age (Years) | Treatment Group | RCT | Formulation | ||
| Quality Score | 24 | Mean (SD): | 76 (NS) | Enrolled: | 12 | Double-blind | Controlled-release MLT |
| Range: | 68–93 | Analyzed: | 12 | Cross-over | Route of Administration | ||
| Gender | Control Group | Oral | |||||
| Female: | 5 | Enrolled: | 12 | Dosage and Timing | |||
| Male: | 7 | Analyzed: | 12 | 2 mg of MLT 2h before desired bedtime | |||
| Ethnicity: NS | Frequency and Duration | ||||||
| Sleep Disorder: Long-term insomnia | One dose/night for 3 weeks | ||||||
| Haimov, I | 1995 | Age (Years) | Treatment Group | RCT | Formulation | ||
| Quality Score | 18 | Mean (SD): | 73.1 (3.9) | Enrolled: | 8 | Double-blind | Sustained-release or Fast-release MLT |
| Range: | NS | Analyzed: | 8 | Cross-over | Route of Administration | ||
| Gender | Control Group | Oral | |||||
| Female: | 4 | Enrolled: | 8 | Dosage and Timing | |||
| Male: | 4 | Analyzed: | 8 | 2 mg FR, 2 mg SR or 1 mg SR MLT 2h before desired bedtime | |||
| Ethnicity: NS | Frequency and Duration | ||||||
| Sleep Disorder: Insomnia | One dose/day of 2 mg FR and 2 mg SR for 1 week, and one dose/day of 1 mg SR for 2 months | ||||||
| McArthur, A | 1998 | Age (Years) | Treatment Group | RCT | Formulation | ||
| Quality Score | 21 | Mean (SD): | 10.1 (1.5) | Enrolled: | 9 | Double-blind | Immediate-release MLT |
| Range | 4–17 | Analyzed: | 9 | Cross-over | Route of Administration | ||
| Gender | Control Group | Oral or by gastrostomy tube | |||||
| Female: | 9 | Enrolled: | 9 | Dosage and Timing | |||
| Male: | 0 | Analyzed: | 9 | Dosage based on individual body weight, range 2.5–7.5 mg of MLT given 1h before bedtime | |||
| Ethnicity: NS | Frequency and Duration | ||||||
| Sleep Disorder: | One dose/day for 4 weeks | ||||||
| Sleep dysfunction accompanying Rett Syndrome | |||||||
| Serfaty, M | 2002 | Age (Years) | Treatment Group | RCT | Formulation | ||
| Quality Score | 22 | Mean (SD): | 84.2 (7.6) | Enrolled: | 44 | Double-blind | Slow release MLT |
| Range: | NS | Analyzed: | 25 | Cross-over | Route of Administration | ||
| Gender | Control Group | Oral | |||||
| Female: | 9 | Enrolled: | 44 | Dosage and Timing | |||
| Male: | 16 | Analyzed: | 25 | 6 mg of MLT at usual bedtime | |||
| Ethnicity: NS | Frequency and Duration | ||||||
| Sleep Disorder: | One dose/day for 2 weeks | ||||||
| Sleep disturbances accompanying dementia | |||||||
| Shamir, E | 2001 | Age (Years) | Treatment Group | RCT | Formulation | ||
| Quality Score | 24 | Mean (SD): | 64.2 (14.3) | Enrolled: | 10 | Double-blind | Controlled-release MLT |
| Range: | 28–82 | Analyzed: | 8 | Cross-over | Route of Administration | ||
| Gender | Control Group | Not specified | |||||
| Female: | 11 | Enrolled: | 12 | Dosage and Timing | |||
| Male: | 11 | Analyzed: | 12 | 2.5 mg MLT, timing: NS | |||
| Ethnicity: NS | Frequency and Duration | ||||||
| Smits, MG | 2003 | Age (Years) | 3 treatments | RCT | Formulation | ||
| Quality Score | 25 | Mean (SD): | FR =0.5mg, 5mg | Double-blind | Fast-release or Controlled-release MLT | ||
| Treatment group | 9.2 (2.1) | CR= 2mg | Parallel | Route of Administration | |||
| Control group | 10.1 (1.7) | Treatment Groups | Oral | ||||
| Range: | NS | Enrolled: | NS | Dosage and Timing | |||
| Gender | Analyzed: | NS | 5 mg of MLT at 19:00 h | ||||
| Treatment group | Control Group | Frequency and Duration | |||||
| Female: | 20 | Enrolled: | NS | One dose/day for 4 weeks | |||
| Male: | 6 | Analyzed: | NS | ||||
| Control group | |||||||
| Female: | 6 | ||||||
| Male: | 29 | ||||||
| Ethnicity: NS | |||||||
| Sleep Disorder: | |||||||
| Idiopathic chronic sleep-onset insomnia | |||||||
| Suhner, A | 1998 | Age (Years) | 3 treatment groups | RCT | Formulation | ||
| Quality Score | 20 | Mean (SD): | 36 (NS) | 0.5 mg FR MLT | Double-blind | Fast-release or Controlled-release MLT | |
| Range: | 20–65 | 5.0 mg FR MLT | Parallel | Route of Administration | |||
| Gender | 2 mg CR MLT | NS | |||||
| Female: | 148 | Treatment Groups | Dosage and Timing | ||||
| Male: | 172 | Enrolled: | NS | 0.5 mg FR, 5.0 mg FR, 2 mg CR MLT at bedtime after 23:10 h +/-1.52 h | |||
| Ethnicity: NS | Analyzed: | NS | Frequency and Duration | ||||
| Sleep Disorder: Jet lag | Control Group | One dose/day for 4 days after eastward flight | |||||
| Enrolled: | NS | ||||||
| Analyzed: | NS | ||||||
Abbreviations: RCT: randomized controlled trial, MLT: melatonin, FR: fast-release, SR: slow-release, SD: standard deviation, mg: milligrams, h: hours, NS: not specified
From: Appendix C: Evidence Tables
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