Effects of melatonin in elderly patients with sleep disturbance: A pilot study

This open-label, short-term pilot study was designed to assess the efficacy and tolerability of melatonin in the treatment of sleep disturbances in elderly patients, The 41 patients (28 women and 13 men; mean age [+/-SD], 74 +/- 12 years) were separated into three groups: (1) patients with sleep disturbances alone (n = 22); (2) patients with sleep disturbances and signs of depression (n = 9); and (3) patients with sleep disturbances and dementia of the degenerative or vascular type (n = 10), All patients received 3-mg gelatin capsules of melatonin orally 30 minutes before expected sleep time for 21 days, Overall sleep quality and daytime alertness mere assessed by means of structured clinical interviews and sleep logs completed by the patients (or their caregivers in the case of dementia patients), Starting from day 2 or 3 of treatment, melatonin significantly improved sleep quality and decreased the number of awakenings in patients with sleep disturbances with or without associated depression, patients with dementia did not show significant improvement of sleep quality, Estimates of next-day function tie, alertness in the morning and during the day) improved significantly only in patients exhibiting sleep disturbances alone, Clinical assessment indicated that symptoms improved in 16 (73%) of the patients with sleep disturbances alone and 4 (44%) of those with sleep disturbances associated with depression, and that agitated behavior at night (sundowning) decreased significantly in 7 (70%) of the patients with dementia, This was reflected by the coefficient of variation of bedtime, which averaged 58% in patients with dementia compared with 27% and 33% in nondepressed and depressed patients, respectively, on days 0 to 2 of treatment, and which decreased significantly only in dementia patients when reassessed on days 19 to 21, Four (31%) of the 13 patients with primary insomnia who were receiving benzodiazepines concomitantly reduced their benzodiazepine use (by 50% to 75% of initial doses) and 4 (31%) discontinued use of these agents; of the 7 patients with depression and 7 with dementia who were receiving benzodiazepines concomitantly, 2 (29%) in each group reduced benzodiazepine use by up to 50%. No side effects considered to be attributable to treatment were reported. The results of this trial suggest that melatonin may be useful for the treatment of primary sleep disturbances in elderly patients.