A double-blind, placebo-controlled investigation of the residual psychomotor and cognitive effects of zolpidem-MR in healthy elderly volunteers.
OBJECTIVE
To assess residual psychomotor and cognitive effects of a modified-release formulation of zolpidem (zolpidem-MR), developed to provide sustained hypnotic efficacy during the whole night, compared with placebo and flurazepam.


METHODS
Twenty-four healthy elderly volunteers received four study treatments (zolpidem-MR 6.25 mg and 12.5 mg, placebo and flurazepam 30 mg) using a randomized, cross-over, double-blind design. Residual psychomotor and cognitive effects were assessed with a psychometric test battery. Quality of sleep and residual effects were evaluated subjectively with the Leeds Sleep Evaluation Questionnaire.


RESULTS
Psychometric performance was significantly impaired with flurazepam but not with zolpidem-MR at either dose. Ease of falling asleep and sleep quality were significantly improved with both doses of zolpidem-MR and with flurazepam. Neither active drug modified perception of well-being on awakening.


CONCLUSIONS
In elderly subjects, zolpidem-MR showed no residual functional impairment in psychometric or cognitive tests sensitive to flurazepam.
Hindmarch
Ian
I
HPRU Medical Research Centre, School of Biomedical & Molecular Sciences, University of Surrey, Guildford, UK. ian@psychopharma.co.uk
Legangneux
Eric
E
Stanley
Neil
N
Emegbo
Steve
S
Dawson
Jean
J
D000328:Adult; D000368:Aged; D003072:Cognition Disorders / Q000139:chemically induced*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D011597:Psychomotor Performance / Q000187:drug effects*; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects*; D012893:Sleep Wake Disorders / Q000188:drug therapy*; D011795:Surveys and Questionnaires / Q000592:standards; D000077334:Zolpidem
D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem