Table 2.
Characteristics of trials of melatonin in people with secondary sleep disorders
|
Intervention
|
||||||||
|---|---|---|---|---|---|---|---|---|
| Study and year | No enrolled (analysed) | Mean (SD or range) age (years) | % male | Disorder | Formulation | Dosage and timing (route) | Frequency and duration | Design |
| Camfield et al, 199614* | 6 | 8.8 (3 to 13) | 67 | Developmental disability | NS | 0.5 or 1.0 mg at 1800 (oral) | For each 2 week interval of 10 week trial, children received melatonin or placebo nightly during first week with alternative agent given on second week | N-of-1 RCT |
| Dodge and Wilson, 200115 | 36 (17) | 7.4 (1 to 15) | NS | Developmental disability | NS | 5 mg at 2000 (oral) | 5 mg/day for weeks 2-3 and 5-6 of 6 week study | RCT; crossover |
| Jan et al, 199416† | 15 | NS (0.5-14) | 87 | Neurological impairment | NS | 2-5 mg at bedtime (NS) | 2-5 mg/day for up to 12 months | N-of-1 RCT |
| Jean-Louis et al, 199817† | 10 | 68.8 (15.8) | 40 | Mild cognitive impairment | NS | 6 mg 2 h before bedtime (NS) | 6 mg/day for 10 days | Non-RCT; crossover |
| McArthur and Budden, 199818 | 9 | 10.1 (1.5) | 0 | Rett syndrome | Immediate release | 2.5-7.5 mg (depending on body weight) given 1 h before bedtime (oral or gastrostomy tube) | 1 capsule/day for 4 weeks | RCT; crossover |
| O'Callaghan et al, 199919 | 7 | Median=11 (2-28) | 43 | Tuberous sclerosis | NS | 5 mg 20 min before bedtime (oral) | 1 capsule/day for 2 weeks | RCT; crossover |
| Serfaty et al, 200220 | 44 (25) | 84.2 (7.6) | 64 | Dementia | Slow release | 6 mg tablet at usual bedtime (oral) | 1 tablet/day for 2 weeks | RCT; crossover |
| Serfaty et al, 200321* | 33 (31) | 39.9 (11.8) | 45 | Major depression | Slow release | 6 mg tablet at bedtime (oral) | 1 tablet/day for 4 weeks | RCT; parallel |
| Shamir et al, 200022* | 27 (19) | 42 (5) | 63 | Schizophrenia | Controlled release | 2 mg 2 h before bedtime (NS) | 2 mg/day for 3 weeks | RCT; crossover |
| Shamir et al, 200023* | 14 | 42.3 (13.1) | 79 | Schizophrenia | Controlled release | 2 mg 2 h before bedtime (NS) | 2 mg/day for 3 weeks | RCT; crossover |
| Singer et al, 200324* | 157 (151) | 77.4 (8.9) | 44 | Alzheimer's disease | Slow release and immediate release | 2.5 mg (SR) or 10 mg (IR) 1 h before bedtime (oral) | 1 capsule/day for 8 weeks | RCT; parallel |
| Van Wieringen et al, 200125† | 81 | 33.4 (10.7) | 27 | Chronic whiplash syndrome | NS | 5 mg 5 h before individual dim light melatonin onset time (oral) | 1 tablet/day for 4 weeks | RCT; parallel |
NS=not specified; RCT-randomised controlled trial.
*Included in efficacy review only; †included in safety review only.