Effects of galantamine versus donepezil on sleep in patients with mild to moderate Alzheimer disease and their caregivers: a double-blind, head-to-head, randomized pilot study.
OBJECTIVE
To examine the effects of galantamine and donepezil on patient and caregiver sleep.


METHODS
In this randomized, 8-week, double-blind, parallel-group, multicenter, pilot comparison of galantamine and donepezil, safety and efficacy data were collected. Objective and subjective changes in sleep of patients (N = 63) and their caregivers were measured. Clinicians assessed changes in patient global function. As this was a pilot study, only descriptive statistics are presented.


RESULTS
In general, neither galantamine nor donepezil, at stable doses, were associated with decrements in actigraphy sleep measurements. However, mean scores in all measures of sleep showed a tendency for minimal improvements in galantamine-treated patients and minimal decrements in the donepezil-treated patients. The same tendencies were present in caregiver sleep measures. Global function either improved or remained stable in a higher percentage of patients treated with galantamine than with donepezil. Galantamine and donepezil were both well tolerated and safe.


CONCLUSIONS
This pilot study was the first to compare the effects of these drugs on sleep in patients or caregivers. Both drugs were safe and well tolerated. Neither galantamine nor donepezil negatively affected sleep; however, on every measure, there were suggestions of slightly more benefit associated with galantamine treatment. Although these results are suggestive of a differential effect of the drugs on sleep, further research is needed to confirm the clinical significance.
Ancoli-Israel
Sonia
S
Department of Psychiatry, University of California San Diego, San Diego, California 92161, USA. sancoliisrael@ucsd.edu
Amatniek
Joan
J
Ascher
Steve
S
Sadik
Kay
K
Ramaswamy
Krishnan
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy / Q000523:psychology*; D017028:Caregivers / Q000523:psychology*; D002800:Cholinesterase Inhibitors / Q000494:pharmacology* / Q000627:therapeutic use; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D005702:Galantamine / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D007189:Indans / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010880:Piperidines / Q000494:pharmacology* / Q000627:therapeutic use; D012890:Sleep / Q000187:drug effects*; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D005702:Galantamine; D000077265:Donepezil