Trazodone improves sleep parameters in Alzheimer disease patients: a randomized, double-blind, and placebo-controlled study.
OBJECTIVE
There are no randomized clinical trials regarding efficacy of trazodone in the treatment of sleep disturbances (SD) in patients with Alzheimer disease (AD). We tested the efficacy and safety of trazodone to treat SD in patients with AD.


METHODS
We conducted a double-blind, randomized and controlled trial during periods of 7-9 days at baseline and 2 weeks of treatment.


METHODS
Geriatric medical center of the university's general hospital.


METHODS
Individuals with probable AD and SD. The complete analysis comprised 30 patients assigned to either the active treatment group (N = 15) or the placebo group (N = 15).


METHODS
Patients received 50 mg of trazodone once daily at 10:00 P.M. or placebo in a 1:1 ratio for 2 weeks.


METHODS
Patients were evaluated using actigraphy and structured scales before and after intervention.


RESULTS
Compared with the placebo group, trazodone users slept 42.5 more minutes per night and had their nighttime percent sleep increased 8.5 percentage points according to actigraphic data post-treatment. Neither trazodone nor placebo induced significant daytime sleepiness or naps. The treatments with trazodone or placebo did not show any effects either on cognition (Mini-Mental State Examination, forward/backward digit span task, letter-number sequencing, arithmetic, digit symbol-coding, and symbol search) or functionality (Katz index). There were no differences in frequency or severity rating of adverse events between the groups.


CONCLUSIONS
This study shows significant therapeutic effects of trazodone 50 mg in community-dwelling AD patients with SD.
Faculty of Medicine, Geriatric Medical Centre, Brasilia University Hospital, University of Brasilia, Brazil; Graduate Program in Medical Sciences, University of Brasilia, Brazil. Electronic address: einstein@unb.br.
Einstein F
EF
Camargos
Faculty of Medicine, Geriatric Medical Centre, Brasilia University Hospital, University of Brasilia, Brazil; Graduate Program in Medical Sciences, University of Brasilia, Brazil.
Luciana L
LL
Louzada
Faculty of Medicine, Geriatric Medical Centre, Brasilia University Hospital, University of Brasilia, Brazil.
Juliana L
JL
Quintas
Faculty of Medicine, Geriatric Medical Centre, Brasilia University Hospital, University of Brasilia, Brazil.
Janeth O S
JO
Naves
Department of Physiology, Federal University of Paraná, Brazil.
Fernando M
FM
Louzada
Faculty of Medicine, Geriatric Medical Centre, Brasilia University Hospital, University of Brasilia, Brazil; Graduate Program in Medical Sciences, University of Brasilia, Brazil.
Otávio T
OT
Nóbrega
D056044:Actigraphy; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000453:epidemiology; D003072:Cognition Disorders / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000453:epidemiology; D014196:Trazodone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome
D017367:Selective Serotonin Reuptake Inhibitors; D014196:Trazodone
Alzheimer disease; Sleep disorders; insomnia; intervention; trazodone; treatment