Efficacy and safety of a one-month treatment with zolpidem in middle-aged and elderly insomniacs

The safety and efficacy of treatment with zolpidem for one month were assessed in an open evaluation by 335 general practitioners in 1219 insomniac patients aged ≤ 50 years. The physician evaluated safety by means of complaints of adverse events reported by the patient at the follow-up visit. Efficacy was assessed by means of changes in the severity of insomnia and the patient's well-being. The investigator evaluated each patient's insomnia using two criteria: lack of nocturnal sleep and its daytime consequences. Severity of lack of nocturnal sleep was assessed by means of an eleven-point scale ranging from 0 = absent to 10 = major. Patient's well-being was based on the assessment of the following parameters: wake-up and daytime condition, mood, and attitude to tasks. Mood and attitude to tasks were assessed in the morning, at midday and in the evening. The total number of adverse events reported was 106 (8.7%) and the most frequent were somnolence, headache, paroniria and vertigo. After one month of treatment with zolpidem, there was a marked and highly significant shift in the severity of the distribution of insomnia from higher to lower scores. Beneficial effects of zolpidem on wake-up/daytime condition, mood and attitude to tasks were also highly significant. This Post-Marketing Surveillance study supports the excellent efficacy and safety of zolpidem in a large sample of middle-aged and elderly subjects with insomnia, reported in previous placebo-controlled studies.SCOPUS: ar.j