title: Extended-release zolpidem: efficacy and tolerability profile.
abstract: Zolpidem is currently the worldwide market leader in the hypnotic arena. It is characterized by a rapid onset of action as well as minimal residual and rebound effects. Its effects on sleep-maintenance parameters, however, have been rather inconsistent. In an attempt to improve this aspect, an extended-release zolpidem formulation has been developed, releasing 60% of the active ingredient immediately, with a slower release of the remainder through the latter part of the night. Volunteer studies have demonstrated that the extended-release formulation has a more prolonged pharmacodynamic effect than the immediate-release one, and is effective in patients on a robust measure of sleep-maintenance difficulty, wake time after sleep onset. A variety of secondary objective and subjective endpoints reflecting sleep initiation and maintenance have also been improved, and minimal residual and rebound effects have been demonstrated. These findings have been echoed in a six-month study using an intermittent dosing paradigm with subjective endpoints.
authors.affiliation: Medical Information Department, Prous Science, Barcelona, Spain. journals@prous.com
authors.forename: Richard T
authors.initials: RT
authors.lastname: Owen
mesh_terms: D003692:Delayed-Action Preparations; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011725:Pyridines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D000077334:Zolpidem
chemical_list: D003692:Delayed-Action Preparations; D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem