• Philip R Gehrman, Donald J Connor, Jennifer L Martin, Tamar Shochat, Jody Corey-Bloom, and Sonia Ancoli-Israel.
• Department of Psychiatry, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
• Am J Geriatr Psychiatry. 2009 Feb 1; 17 (2): 166-9.

ObjectivesPatients 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.DesignRandomized, placebo-controlled study.SettingNursing homes in San Diego, CA, metropolitan area.ParticipantsSubjects were patients with probable Alzheimer disease.InterventionMelatonin (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.MeasurementsSleep 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.ResultsThere were no significant effects of melatonin, compared with placebo, on sleep, circadian rhythms, or agitation.Conclusion: 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.

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