P03-397 - Long-term efficacy and safety of zolpidem extended-release 12.5 mg, in old patients with chronic primary insomnia: a randomized, double-blind, placebo-controlled, parallel-group, multicenter study

Objective To evaluate long-term efficacy and safety of zolpidem extended-release, in old patients for chronic primary insomnia. Design Multicenter, randomized, double-blind, placebo-controlled, parallel-group. Method Population: Outpatient with aged more of 65 years. Diagnosis: DSM-IV criteria for chronic primary insomnia; Treatment: Single-dose zolpidem extended-release 12.5 mg (n = 128) or placebo (n = 127), self-administered every night. Results Patient's Global Impression (PGI) and Clinical Global Impression-Improvement (CGI-I) were assessed every 4 weeks up to six month. Patient Morning Questionnaire (PMQ), recorded daily, assessed subjective sleep measures-sleep onset latency (SOL), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and quality of sleep (QOS)-and next-day functioning. Zolpidem extended-release also was statistically significantly superior to placebo at every time point for PGI (Items 1–4) and CGI-I (P  Conclusions These findings establish the efficacy of dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness.