Melatonin, produced by the pineal gland at night, has a role in regula
tion of the sleep-wake cycle. Among elderly people, even those who are
healthy, the frequency of sleep disorders is high and there is an ass
ociation with impairment of melatonin production. We investigated the
effect of a controlled-release formulation of melatonin on sleep quali
ty in 12 elderly subjects (aged 76 [SD 8] years) who were receiving va
rious medications for chronic illnesses and who complained of insomnia
. In all 12 subjects the peak excretion of the main melatonin metaboli
te 6-sulphatoxymelatonin during the night was lower than normal and/or
delayed in comparison with non-insomniac elderly people. In a randomi
sed, double blind, crossover study the subjects were treated for 3 wee
ks with 2 mg per night of controlled-release melatonin and for 3 weeks
with placebo, with a week's washout period. Sleep quality was objecti
vely monitored by wrist actigraphy. Sleep efficiency was significantly
greater after melatonin than after placebo (83 [SE 4] vs 75 [3]%, p<0
.001) and wake time after sleep onset was significantly shorter (49 [1
4] vs 73 [13] min, p<0.001). Sleep latency decreased, but not signific
antly (19 [5] vs 33 [7] min, p=0.088). Total sleep time was not affect
ed. The only adverse effects reported were two cases of pruritus, one
during melatonin and one during placebo treatment; both resolved spont
aneously. Melatonin deficiency may have an important role in the high
frequency of insomnia among elderly people. Controlled-release melaton
in replacement therapy effectively improves sleep quality in this popu
lation.