A trial was carried out to determine the effect of ritanserin or a pla
cebo on sleep and mood in two groups of abstinent alcoholic patients.
Their condition was characterized by both alcohol dependence and dysth
ymia, associated with a personality disorder. They were included in th
e study after 30 days of sobriety. Ritanserin was given at a daily dos
e of 10 mg for 28 days and was preceded (10 days) and followed (2 days
) by a placebo. Plasma ritanserin concentration after administration o
f the 28th dose was higher than after the first dose. Peak levels of r
itanserin from the first to the 28th dose increased approximately thre
e-fold. In the ritanserin group there was a reduction of total waking
time. Total sleep time increase was associated with significantly larg
er amounts of nonrapid eye movement sleep. Slow wave sleep and rapid e
ye movement sleep (in minutes or as a percent of total sleep time) wer
e not significantly modified. Patients on ritanserin achieved a progre
ssive improvement of their dysthymia. As compared to the placebo group
, a statistically significant decrease of the Hamilton Rating Scale fo
r Depression and Hamilton Rating Scale for Anxiety was found in the ri
tanserin group after 1 week of treatment. The absence of an effect in
the placebo-treated group suggests that the clinical response and slee
p improvement were mainly related to ritanserin administration.