Efficacy and safety of modified release zolpidem in patients with chronic insomnia
Main Article Content
Keywords
Sleep initiation and maintenance disorders, Hypnotics and sedatives
Abstract
Objective: to assess the efficacy and safety of zolpidem modified release (MR) on an “as per needed basis” in patients with chronic insomnia.
Methods: one hundred and thirty five adult patients with chronic insomnia were recruited. Participants received zolpidem MR 12.5 mg during a 12 weeks period. Severity and improvement of insomnia were assessed at baseline and at the end of study using the clinical global impression scale; sleep quality was assessed by the application of the Pittsburgh Sleep Quality Index; drug consumption behavior was evaluated through tablet counting; in addition its security was assessed by the registry of the adverse effects.
Results: one hundred and fifteen patients completed the study; 83.7 % were considered improved or very improved, so that 66 % reached a normal or borderline condition. Twenty percent of subjects experienced adverse reactions; the most frequent were headache, excessive sleepiness, nausea and dizziness.
Conclusions: these data support the efficacy, safety and acceptance of zolpidem MR administered on an “as per needed” regimen for the treatment of chronic insomnia.
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