Several recent clinical trials have established that
reboxetine, a new selective
norepinephrine reuptake inhibitor (selective NRI), is effective and safe for the treatment of major depression. However, the effects of
reboxetine on specific symptoms of anxiety, agitation, and
insomnia have not been reported. Data were obtained from nine short-term, double-blind, randomized clinical trials in patients with major depression. After initial titration, patients received
reboxetine 8 to 10 mg per day. The effects on specific HAM-D symptoms of agitation, anxiety, and
insomnia were compared between
reboxetine-and placebo-treated patients. In addition, the incidence of treatment-emergent agitation, anxiety, and
insomnia side effects with
reboxetine were examined. Compared with placebo, the proportion of patients with improvement on the HAM-D agitation item and the HAM-D anxiety and
insomnia factors from baseline was significantly greater with
reboxetine at most assessment intervals. In general, the incidence of agitation-or anxiety-related side effects was comparable with
reboxetine and placebo. Although
reboxetine was associated with a significant (p < 0.05) increase in treatment-emergent
insomnia reported as an adverse effect during the first week of treatment, very few reports of
insomnia were made at subsequent evaluations. The incidence of treatment-emergent agitation or anxiety was comparable between treatment groups.