Evaluation of the efficacy of pivagabine on insomnia associated with mood disorders.

The efficacy of a new drug, pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg), was studied on 100 patients affected by insomnia, associated with mood disorders. The pharmacological treatment with 900 mg/d pivagabine produced a significant improvement in the quality of both sleep and awakening. The results shown in the present study were positive and likely attributable to the inhibitory modulating activity of pivagabine on corticotropin releasing factor secretion, that is considered to be responsible for insomnia associated with anxiety or coexisting anxiety and depression, observed in patients with chronic stress. The recovery of sleep physiological structure provokes a significant reduction in the criteria reported in the Self-rating Anxiety Scale (SAS).