A double-blind, placebo- and flurazepam-controlled investigation of the residual psychomotor and cognitive effects of modified release zolpidem in young healthy volunteers.

Short-acting hypnotic drugs, such as zolpidem, have minimal residual effects but may not provide optimal efficacy throughout the night for all insomnia patients. A modified-release formulation of zolpidem, zolpidem-MR, has been developed to overcome this limitation. This was a phase I, double-blind, 3-way crossover, placebo-controlled study to investigate the residual psychomotor and cognitive effects of a single oral dose of zolpidem-MR 12.5 mg in 18 healthy young adults. Flurazepam 30 mg was used as a positive control. No comparison with standard immediate-release zolpidem was made. Five neuropsychological tests and 2 subjective tests were performed 8 hours after dosing. The safety of zolpidem-MR was also investigated. Performance on the Critical Flicker Fusion Frequency test, Choice Reaction Time, Immediate and Delayed Word Recall, and the Compensatory Tracking Task was significantly impaired by flurazepam but not by zolpidem-MR (with the exception of the Compensatory Tracking Task) or placebo. No significant effects were observed on the Digit Symbol Substitution Test. The Leeds Sleep Evaluation Questionnaire showed that both drugs improved the ease of getting to sleep and perceived quality of sleep, whereas only flurazepam significantly impaired the ease of awakening. Neither drug scored significantly better than placebo on the Bond and Lader contentedness scale, but both induced a significant difference in calmness; only flurazepam significantly reduced alertness. The safety profile of zolpidem-MR was comparable to placebo. In conclusion, the study showed the good tolerance of zolpidem-MR in terms of residual neuropsychological effects as well as a beneficial effect on sleep quality in young healthy adults.

RCT Entities:   Population Interventions Outcomes