EFFECTS OF MELATONIN IN ELDERLY PATIENTS WITH SLEEP DISTURBANCE - A PILOT-STUDY

This open-label, short-term pilot study was designed to assess the eff icacy and tolerability of melatonin in the treatment of sleep disturba nces in elderly patients, The 41 patients (28 women and 13 men; mean a ge [+/-SD], 74 +/- 12 years) were separated into three groups: (1) pat ients with sleep disturbances alone (n = 22); (2) patients with sleep disturbances and signs of depression (n = 9); and (3) patients with sl eep 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 qual ity and daytime alertness mere assessed by means of structured clinica l interviews and sleep logs completed by the patients (or their caregi vers in the case of dementia patients), Starting from day 2 or 3 of tr eatment, melatonin significantly improved sleep quality and decreased the number of awakenings in patients with sleep disturbances with or w ithout associated depression, patients with dementia did not show sign ificant improvement of sleep quality, Estimates of next-day function t ie, alertness in the morning and during the day) improved significantl y only in patients exhibiting sleep disturbances alone, Clinical asses sment indicated that symptoms improved in 16 (73%) of the patients wit h sleep disturbances alone and 4 (44%) of those with sleep disturbance s associated with depression, and that agitated behavior at night (sun downing) decreased significantly in 7 (70%) of the patients with demen tia, This was reflected by the coefficient of variation of bedtime, wh ich averaged 58% in patients with dementia compared with 27% and 33% i n nondepressed and depressed patients, respectively, on days 0 to 2 of treatment, and which decreased significantly only in dementia patient s when reassessed on days 19 to 21, Four (31%) of the 13 patients with primary insomnia who were receiving benzodiazepines concomitantly red uced their benzodiazepine use (by 50% to 75% of initial doses) and 4 ( 31%) discontinued use of these agents; of the 7 patients with depressi on and 7 with dementia who were receiving benzodiazepines concomitantl y, 2 (29%) in each group reduced benzodiazepine use by up to 50%. No s ide 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.