Melatonin fails to improve sleep or agitation in double-blind randomized placebo-controlled trial of institutionalized patients with Alzheimer disease.
OBJECTIVE
Patients with Alzheimer dementia often display both agitated behavior and poor sleep. Given that the disease is often associated with low endogenous levels of melatonin, exogenous melatonin administration may lead to improvements in sleep and agitation.


METHODS
Randomized, placebo-controlled study.


METHODS
Nursing homes in San Diego, CA, metropolitan area.


METHODS
Subjects were patients with probable Alzheimer disease.


METHODS
Melatonin (8.5 mg immediate release and 1.5 mg sustained release) (N = 24) or placebo (N = 17) administered at 10:00 P.M. for 10 consecutive nights. The protocol consisted of baseline (3 days), treatment (10 days), and posttreatment (5 days) phases.


METHODS
Sleep was measured continuously using actigraphy. Agitation was rated using both the Agitated Behavior Rating Scale and the Cohen-Mansfield Agitation Inventory. Treatment effects were examined both across the 24-hr day and separately by nursing shift.


RESULTS
There were no significant effects of melatonin, compared with placebo, on sleep, circadian rhythms, or agitation.


CONCLUSIONS
: This study failed to find a beneficial effect of exogenous melatonin, consistent with a number of other studies. The lack of efficacy may be related to the absence of a true treatment effect or to the superphysiologic dose of melatonin used.
Gehrman
Philip R
PR
Department of Psychiatry, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
Connor
Donald J
DJ
Martin
Jennifer L
JL
Shochat
Tamar
T
Corey-Bloom
Jody
J
Ancoli-Israel
Sonia
S
D000368:Aged; D000544:Alzheimer Disease / Q000150:complications*; D002492:Central Nervous System Depressants; D002940:Circadian Rhythm / Q000187:drug effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D015577:Geriatric Assessment; D006801:Humans; D008550:Melatonin / Q000008:administration & dosage / Q000627:therapeutic use*; D009735:Nursing Homes; D010919:Placebos / Q000627:therapeutic use; D017286:Polysomnography; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy*; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000188:drug therapy*
D002492:Central Nervous System Depressants; D010919:Placebos; D008550:Melatonin