Z-Drugs for Sleep Disorders in Alzheimer's Disease

Inclusion Criteria:

• 55 years of age or older
• Diagnosis of probable Alzheimer's disease (AD) by National Institute of Neurologicaland Communicative Disorders and Stroke / the Alzheimer's Disease and Related DisordersAssociation Criteria
• Hachinski Ischemia Scale less than 5
• Mini-Mental State Examination score of 0 to 26
• Actigraph evidence of a mean time immobile of less than 7 hours per night based on atleast 7 nights of complete actigraph data collected over a single week
• Four-week history of sleep disorder behaviors, occurring at least once weekly, asreported by the caregiver using the Neuropsychiatric Inventory (NPI) NighttimeBehavior scale
• Sleep disturbance observed was not present before the diagnosis of AD
• Other co-morbidities, especially delirium, depression, chronic pain and medication usemay be present, but do not cooperate in the primary symptoms
• Computed tomography or magnetic resonance imaging since the onset of memory problemsshowing no more than 1 lacunar infract in a nonstrategic area and no clinical eventssuggestive of stroke or other intracranial disease or normal
• Stable medications for 4 weeks prior to the screening visit
• Having a mobile upper extremity to which to attach an actigraph
• Residing with a responsible spouse, family member, or professional caregiver who ispresent during the night and would agree to assume the role of the principle caregiverfor the 3-week protocol
• Ability to ingest oral medication and participate in all scheduled evaluations

Exclusion Criteria:

• Sleep disturbance associated with an acute illness, delirium or psychiatric disease
• Clinically significant movement disorder, such as akinesia, that would affectactigraphic differentiation of sleep and wakefulness
• Severe agitation
• Unstable medical condition
• Discontinuation of psychotropic or sleep medication within 2 weeks of the screeningvisit
• Patient unwilling to maintain caffeine abstinence after 2:00pm for the duration of theprotocol
• Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, andonly 1 alcoholic drink after 6:00pm for the duration of the protocolo
• Prior use of zolpidem/zoplicone for the treatment os sleep disturbances
• Caregiver deemed to be unreliable to supervise the wearing of the actigraph, toadminister study capsules at the proper time, to maintain the sleep diary, or to bringthe patient to the scheduled visits