TY - JOUR
T1 - A double-blind, randomized and placebo-controlled study on the polysomnographic withdrawal effects of zopiclone, zolpidem and triazolam in healthy subjects
AU - Voderholzer, U.
AU - Riemann, D.
AU - Hornyak, M.
AU - Backhaus, J.
AU - Feige, B.
AU - Berger, M.
AU - Hohagen, F.
N1 - Funding Information:
■ Acknowledgments The authors would like to thank Ms Gerda Deeb and Ms Claudine Heinrich for visual analysis of sleep EEG, Drs Wilhelm Fischer and Cäcilia Haarmann from the Rhone-Poulenc Rorer Company (now Aventis) and Dr. Franz Eich from the Synthe-labo (now Sanofi-Synthelabo) Company for financial support.
PY - 2001
Y1 - 2001
N2 - Rebound effects after withdrawal from hypnotics are believed to trigger their chronic use and to enhance the risk of tolerance and dependence. It was the purpose of this study to investigate the acute polysomnographic withdrawal effects after a 4 week treatment with standard doses of the non-benzodiazepine hypnotics zopiclone and zolpidem compared with triazolam and placebo. Healthy male subjects between 22 and 35 years of age participated in a parallel study design. They received either zopiclone 7.5 mg (n=11), zolpidem 10 mg (n=11), triazolam 0.25 mg (n=10) or placebo (n=7) over 4 weeks in randomized and double-blind order. Sleep EEG was registered during 2 nights before treatment under placebo, on days 1, 27 and 28 of treatment and on days 29, 30, 41 and 42 under placebo. Total sleep time and sleep efficiency were lower in the 1st night after discontinuation of triazolam (p < 0.05, t-test). After withdrawal from zopiclone or zolpidem slight but not significant rebound effects concerning sleep continuity were observed. Self-rating scales showed minimal rebound insomnia after discontinuation of all three hypnotics. In the placebo group no changes of sleep parameters were observed. Assuming that rebound insomnia is part of a withdrawal reaction, this study indicates that the risks of tolerance and dependency are low when administering zopiclone or zolpidem at the recommended doses.
AB - Rebound effects after withdrawal from hypnotics are believed to trigger their chronic use and to enhance the risk of tolerance and dependence. It was the purpose of this study to investigate the acute polysomnographic withdrawal effects after a 4 week treatment with standard doses of the non-benzodiazepine hypnotics zopiclone and zolpidem compared with triazolam and placebo. Healthy male subjects between 22 and 35 years of age participated in a parallel study design. They received either zopiclone 7.5 mg (n=11), zolpidem 10 mg (n=11), triazolam 0.25 mg (n=10) or placebo (n=7) over 4 weeks in randomized and double-blind order. Sleep EEG was registered during 2 nights before treatment under placebo, on days 1, 27 and 28 of treatment and on days 29, 30, 41 and 42 under placebo. Total sleep time and sleep efficiency were lower in the 1st night after discontinuation of triazolam (p < 0.05, t-test). After withdrawal from zopiclone or zolpidem slight but not significant rebound effects concerning sleep continuity were observed. Self-rating scales showed minimal rebound insomnia after discontinuation of all three hypnotics. In the placebo group no changes of sleep parameters were observed. Assuming that rebound insomnia is part of a withdrawal reaction, this study indicates that the risks of tolerance and dependency are low when administering zopiclone or zolpidem at the recommended doses.
UR - http://www.scopus.com/inward/record.url?scp=0034793190&partnerID=8YFLogxK
U2 - 10.1007/s004060170045
DO - 10.1007/s004060170045
M3 - Journal articles
C2 - 11697572
AN - SCOPUS:0034793190
SN - 0940-1334
VL - 251
SP - 117
EP - 123
JO - European Archives of Psychiatry and Clinical Neuroscience
JF - European Archives of Psychiatry and Clinical Neuroscience
IS - 3
ER -
