Z-Drugs for Sleep Disorders in Alzheimer's Disease

Summary

The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)

Timeline

Start

2016-10

Primary completion

2020-04

Completion

2020-04

Outcome

Missed primary endpoint

paper Zolpidem yielded no significant difference in MNSD despite a significant 22 min reduction in WASO PMID 34635802 ↗

paper Zopiclone produced an 81 min increase in MNSD (95% confidence interval (CI): -0.8, 163.2) PMID 34635802 ↗

Publications

• Louzada LL, Machado FV, Quintas JL, Ribeiro GA, Silva MV, Mendonca-Silva DL, Goncalves BSB, Nobrega OT, Camargos EF. The efficacy and safety of zolpidem and zopiclone to treat insomnia in Alzheimer's disease: a randomized, triple-blind, placebo-controlled trial. Neuropsychopharmacology. 2022 Jan;47(2):570-579. doi: 10.1038/s41386-021-01191-3. Epub 2021 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zolpidem	Small molecule	10 mg	—
Subject	Zopiclone	Small molecule	7.5 mg	—

Indications