: OBJECTIVES: A retrospective study on the efficacy of melatonin in treatment of sleep and cognitive disorders of Alzheimer's disease was conducted. METHODS: Fourteen patients (8 females, 6 males), mean +/- S.D. age 72 +/- 9 years were included. All patients received 9 mg gelatin melatonin capsules p.o. daily at bedtime for 22 to 35 months. Overall quality of sleep was assessed from sleep logs filled in by the patients or their caretakers. Neuropsychological evaluation was performed by Functional Assessment Tool For Alzheimer's Disease (FAST), Mini-Mental, Alzheimer's Disease Assessment Scale (ADAS), and Mattis' and Blessed's scales. At diagnosis, all patients had cognitive and neuroimaging alterations (cortical and bitemporal atrophy) compatible with different evolutionary stages of the disease. RESULTS: At the time of assessment, a significant improvement of sleep quality was found in all cases examined. There were no significant differences between initial and present evaluation in scores of FAST, Mini-Mental, and ADAS, and of Mattis' and Blessed's scales. Clinically, the patients exhibited lack of progression of the cognitive and behavioral signs of the disease during the time they received melatonin. Sundowning was no longer detectable in 12 patients and persisted, although attenuated, in 2 patients. CONCLUSION. The results suggest that melatonin can be useful for treatment of Alzheimer's disease.