OBJECTIVE AND DESIGN: This open, non-comparative, multicentre study was designed to evaluate zolpidem consumption and evolution of its use for the treatment of insomnia on an 'as-needed' basis, under the real conditions of routine general practice. PATIENTS AND METHODS: 1938 patients (aged >18 years) with insomnia (mean +/- SD duration: 3.0 +/- 15.2 months; median duration: 1 month) were enrolled. A maximum of 21 doses were prescribed for the treatment period (3 weeks maximum) and patients were instructed to take zolpidem according to their sleep disturbance ('as needed'). The main criteria were number of doses/week and consumption evolution over the treatment period. Secondary criteria included the evolution of disease severity, the evolution of parameters of sleep quality and factors predictive of the evolution of zolpidem consumption. RESULTS: Consumption decreased steadily during the study, from 5.1 +/- 1.9 doses/week during week 1 to 3.7 +/- 2.5 doses/week during week 3. A prior sleep-disorder episode (p = 0.02), high initial zolpidem consumption with 6-7 doses/week (p < 0.001) or insomnia having started >3 weeks before the inclusion (p < 0.001) were predictive of stable or increased zolpidem consumption. Global clinical improvement showed moderate to very marked improvement for 90% of the patients. Other sleep-quality and clinical-improvement parameters indicated overall satisfaction. Nature, incidence and severity of safety data reported during the study were consistent with the safety experience reported to date. CONCLUSION: During zolpidem 'as-needed' administration in general practice, patients adapted the treatment to their needs and to the evolution of their insomnia. The treatment had a good safety profile and was effective.
OBJECTIVE AND DESIGN: This open, non-comparative, multicentre study was designed to evaluate zolpidem consumption and evolution of its use for the treatment of insomnia on an 'as-needed' basis, under the real conditions of routine general practice. PATIENTS AND METHODS: 1938 patients (aged >18 years) with insomnia (mean +/- SD duration: 3.0 +/- 15.2 months; median duration: 1 month) were enrolled. A maximum of 21 doses were prescribed for the treatment period (3 weeks maximum) and patients were instructed to take zolpidem according to their sleep disturbance ('as needed'). The main criteria were number of doses/week and consumption evolution over the treatment period. Secondary criteria included the evolution of disease severity, the evolution of parameters of sleep quality and factors predictive of the evolution of zolpidem consumption. RESULTS: Consumption decreased steadily during the study, from 5.1 +/- 1.9 doses/week during week 1 to 3.7 +/- 2.5 doses/week during week 3. A prior sleep-disorder episode (p = 0.02), high initial zolpidem consumption with 6-7 doses/week (p < 0.001) or insomnia having started >3 weeks before the inclusion (p < 0.001) were predictive of stable or increased zolpidem consumption. Global clinical improvement showed moderate to very marked improvement for 90% of the patients. Other sleep-quality and clinical-improvement parameters indicated overall satisfaction. Nature, incidence and severity of safety data reported during the study were consistent with the safety experience reported to date. CONCLUSION: During zolpidem 'as-needed' administration in general practice, patients adapted the treatment to their needs and to the evolution of their insomnia. The treatment had a good safety profile and was effective.
Authors: M M Ohayon; M Caulet; L Arbus; M Billard; A Coquerel; J D Guieu; B Kullmann; F Loffont; P Lemoine; J Paty; J C Pechadre; M F Vecchierini; H Vespignani Journal: J Psychosom Res Date: 1999-10 Impact factor: 3.006