Use of pivagabine in the management of hospitalization distress in children.

A double-blind, placebo-controlled study was performed in order to evaluate the efficacy of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg) on "distress" in children hospitalized for acute disorders. Ninety children (43 boys and 47 girls) aged between 2 and 13 years were randomly distributed into two groups of equal size. The first group was treated with 450-900 mg/d of pivagabine by oral route, whereas the second group was given identical quantities of placebo. Treatment was continued for 21 days, with a medical examination after 7 days and another at its termination. Diurnal behaviour, motor activity, attention, sleep disturbances (insomnia) and sleep characteristics and behaviour upon awakening were assessed during treatment by means of a semiquantitative rating scale. Pivagabine induced significantly greater improvement in all the items listed above as compared to the control group. In many cases complete remission of the symptoms of "distress" was recorded. The results obtained therefore confirm the hypothesis that pivagabine acts by intervening on the biochemical mechanisms that regulate the CNS adjustment response to stress. It is likely that the intervention consists in the inhibition of the release of hypothalamic corticotropin releasing factor.