Table 5.
Characteristics of trials of people with sleep disorders accompanying sleep restriction
|
Intervention
|
||||||||
|---|---|---|---|---|---|---|---|---|
| Study and year | No enrolled (analysed) | Mean (SD or range) age (years) | % male | Disorder | Formulation | Dosage and timing (route) | Frequency and duration | Design |
| Beaumont et al, 200426* | 27 (18) | 35.3 (8.1) | 67 | Jet lag | NS | 5 mg on day -1 at 1700; on day 0 at 1600; on day 1 to day 3 at 2300 (NS) | 5 mg/day for 5 days | RCT; parallel |
| Claustrat et al, 199227† | 37 (15) | Melatonin 36.3 (8.9); placebo: 35.7 (6.4) | Melatonin 53; placebo 67 | Jet lag | NS | 8 mg at 2200 (oral) | 1 capsule/day for 4 days | RCT; parallel |
| Edwards et al, 200028† | 31 | Melatonin 40 (13); placebo 41 (12) | Melatonin 93; placebo 88 | Jet lag | NS | 5 mg taken on plane between 1800 to 1900 and between 2200 to 2300, according to local time at destination and for next 3 evenings | 2 capsules/day for first day and then 1 capsule/day for 3 days | non-RCT; parallel |
| Folkard et al, 199329* | 17 (7) | 29 (7) | 88 | Shiftwork disorder | NS | 5 mg at 0642 ± 7.6 min (oral) | 1 capsule/day for 6 successive day sleeps taken between night shifts | RCT; crossover |
| James et al, 199830 | 24 (22) | 29 (8) | 77 | Shiftwork disorder | NS | 6 mg 0.5 h before each consecutive day sleep (oral) | 6 mg/day for 4 treatment cycles lasting 4 to 6 consecutive night shifts | RCT; crossover |
| Jockovich et al, 200031 | 19 | 28.2 (NS) | 21 | Shiftwork disorder | NS | 1 mg 0.5 to 1 h before daytime sleep (oral) | 1 caplet/day for 3 consecutive days | RCT; crossover |
| Jorgensen and Witting, 199832 | 20 (18) | 32 (25 to 40) | 89 | Shiftwork disorder | NS | 10 mg morning after each night shift (oral) | 1 tablet/day for varied amount of time | RCT; crossover |
| Petrie et al, 198933† | 20 (15) | NS (28 to 68) | 60 | Jet lag | NS | 5 mg taken between 1000 and 1200 local time; also taken at the same time during the flight and between 2200 and 2400 (destination time) after arrival (NS) | 1 dose for 3 days before flight, 1 dose during flight, and 1 dose/day for 3 days after arrival | RCT; crossover |
| Petrie et al, 199334† | 52 (44) | 34.9 (7.7) | 50 | Jet lag | NS | 5 mg taken between 0700 to 0800 | 5 mg early melatonin for 8 days, 5 mg late melatonin for 5 days | RCT; parallel |
| Suhner et al, 199835 | 320 (234) | 20 to 65 | 54 | Jet lag | Fast release and controlled release | 0.5 mg fast release, 5 mg fast release, or 2 mg controlled release melatonin on first day after flight at 2310 and on subsequent days at 2329 (NS) | 1 dose/day for 4 days after eastward flight | RCT; parallel |
| Suhner et al, 200136 | 160 (74) | 41.3 (18 to 68) | 51 | Jet lag | NS | 5 mg taken on return flight (eastbound) between 1700 and 2100 local time at the place of departure depending on flight schedule (NS) | 1 dose/day on return flight and for 4 consecutive days after flight | RCT; parallel |
| Waldhauser et al, 199037* | 20 (20) | 26.4 (4.8) | 50 | Induced insomnia | NS | 80 mg at 2100 (oral) | Single dose | RCT; parallel |
| Wright et al, 199838 | 20 (15) | 38.6 (32 to 45) | 80 | Shiftwork disorder | NS | 5 mg 30 min before bedtime in the evening (oral) | 5 mg/night for 3 nights following shift work | RCT; crossover |
NS=not specified.
* Included in efficacy review only; †included in safety review only.