Niaprazine is a histamine H-1-receptor antagonist with marked sedative prop
erties. It has been employed in subjects with behavior and sleep disorders.
No data concerning the use of niaprazine in subjects with autistic disorde
r are reported in the Literature. The authors performed an open study to as
sess niaprazine efficacy in a sample of 25 subjects with autistic disorder
and associated behavior and sleep disorders. Niaprazine was administered at
1 mg/kg/day for 60 days. A positive effect was found in 52% of patients, p
articularly on hyperkinesia, unstable attention, resistance to change and f
rustration, mild anxiety signs, heteroaggressiveness, and sleep disorders.
Statistical comparison between responders and nonresponders showed no influ
ence on niaprazine effect by age over or under 12 years, presence of neurol
ogic signs, epilepsy, or abnormalities seen on brain imaging. Niaprazine wa
s more efficacious in subjects with a mild or moderate degree of mental ret
ardation. No side effects were observed. Because of its sedative effects an
d good tolerability, niaprazine can be used as a first-choice drug to impro
ve behavior and sleep disorders in patients with autistic disorder.