Next-day residual effects of gaboxadol and flurazepam administered at bedtime: a randomized double-blind study in healthy elderly subjects.
OBJECTIVE
To evaluate the next-day residual effects of the novel hypnotic, gaboxadol, following bedtime dosing in healthy elderly subjects.


METHODS
Healthy women (N = 15) and men (N = 10) aged 65-79 years received a single bedtime (22:00 h) dose of gaboxadol 10 mg, flurazepam 30 mg (positive control), and placebo in a randomized, double-blind, crossover study. Measures of information processing and psychomotor performance (choice reaction time, critical flicker fusion, digit symbol substitution, compensatory tracking, body sway), memory (immediate and delayed word recall), and daytime sleepiness (Multiple Sleep Latency Test), as well as subjective ratings (line analog rating scales, Leeds Sleep Evaluation Questionnaire), were obtained starting at 07:00 h the following morning. Adverse events were recorded.


RESULTS
Gaboxadol did not show next-day impairments versus placebo on any pharmacodynamic measures whereas the positive control, flurazepam, did show impairments versus placebo on most measures. Gaboxadol showed improvements versus placebo on some measures including subjective rating of next-day alertness/clumsiness on the Leeds Sleep Evaluation Questionnaire. Gaboxadol was generally well-tolerated; there were no serious adverse experiences and no subjects discontinued due to an adverse experience.


CONCLUSIONS
A single oral bedtime dose of gaboxadol 10 mg did not have next-day residual effects in healthy elderly subjects, as measured by a range of pharmacodynamic assessments, in contrast to the clear impairments produced by flurazepam 30 mg.
Boyle
Julia
J
Human Psychopharmacology Research Unit, University of Surrey, Guildford, Surrey, UK. j.boyle@surrey.ac.uk
Wolford
Dennis
D
Gargano
Cynthia
C
McCrea
Jacqueline
J
Cummings
Corinne
C
Cerchio
Kristine
K
Lines
Christopher
C
D000284:Administration, Oral; D000368:Aged; D018592:Cross-Over Studies; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005479:Flurazepam / Q000008:administration & dosage / Q000009:adverse effects*; D018755:GABA Agonists / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects*; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D011939:Mental Recall / Q000187:drug effects; D011597:Psychomotor Performance / Q000187:drug effects; D011930:Reaction Time / Q000187:drug effects; D011795:Surveys and Questionnaires; D013997:Time Factors
D018755:GABA Agonists; D006993:Hypnotics and Sedatives; D007555:Isoxazoles; D005479:Flurazepam; C015542:gaboxadol