Document Detail

Long-term use of sedative hypnotics in older patients with insomnia.
MedLine Citation:
PMID:  15716214     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND PURPOSE: Insomnia is a common problem that increases with age and can last months to years. While substantial data establish the efficacy and safety of short-acting hypnotic therapy for the management of short-term insomnia using benzodiazepines receptor agonists (BzRAs), there are few studies on the continued efficacy and safety of these drugs when used for sustained periods. This paper reports the results of a 1-year open-label extension phases of two randomized, double-blind trials of zaleplon. PATIENTS AND METHODS: In the open-label phase, older patients self-administered zaleplon nightly from 6 to 12 months and were then followed through a 7-day single-blind placebo-controlled run-out period. RESULTS: The safety profile in this population of older adults was similar to that observed in a short-term trial of an equivalent population. The data also suggested that long-term therapy produced and maintained statistically significant improvement in time to persistent sleep onset, duration of sleep and number of nocturnal awakenings (P<0.001 for each variable) for treatment durations of up to 12 months. Discontinuation was not associated with rebound insomnia. CONCLUSION: The open-label trial of long-term hypnotic therapy with zaleplon 5 and 10 mg suggests that they are safe and effective for the treatment of insomnia in older patients. Placebo-controlled, double-blind trials are needed in zaleplon and other BzRAs to confirm these results.
Sonia Ancoli-Israel; Gary S Richardson; Richard M Mangano; Lisa Jenkins; Phil Hall; Walter S Jones
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2005-01-26
Journal Detail:
Title:  Sleep medicine     Volume:  6     ISSN:  1389-9457     ISO Abbreviation:  Sleep Med.     Publication Date:  2005 Mar 
Date Detail:
Created Date:  2005-02-17     Completed Date:  2005-07-15     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100898759     Medline TA:  Sleep Med     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  107-13     Citation Subset:  IM    
Department of Psychiatry 116A, University of California San Diego and Veterans Affairs, San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA 92161, USA.
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MeSH Terms
Acetamides / administration & dosage,  pharmacology,  therapeutic use*
Aged, 80 and over
Double-Blind Method
Hypnotics and Sedatives / administration & dosage,  pharmacology,  therapeutic use*
Middle Aged
Pyridines / administration & dosage,  pharmacology,  therapeutic use*
Pyrimidines / administration & dosage,  pharmacology,  therapeutic use*
Receptors, GABA-A / metabolism
Single-Blind Method
Sleep Initiation and Maintenance Disorders / drug therapy*
Wakefulness / drug effects
Reg. No./Substance:
0/Acetamides; 0/Hypnotics and Sedatives; 0/Pyridines; 0/Pyrimidines; 0/Receptors, GABA-A; 151319-34-5/zaleplon; 82626-48-0/zolpidem

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