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Health Technology Assessment... Jun 2004To assess the clinical and cost-effectiveness of zaleplon, zolpidem and zopiclone (Z-drugs) compared with benzodiazepines. (Comparative Study)
Comparative Study Review
OBJECTIVES
To assess the clinical and cost-effectiveness of zaleplon, zolpidem and zopiclone (Z-drugs) compared with benzodiazepines.
DATA SOURCES
Electronic databases, reference lists of retrieved articles and pharmaceutical company submissions.
REVIEW METHODS
Randomised controlled trials (RCTs) that compared either benzodiazepines to the Z-drugs or any two of the non-benzodiazepine drugs in patients with insomnia were included in the review. Data on the following outcome measures were considered: sleep onset latency, total sleep duration, number of awakenings, quality of sleep, adverse effects and rebound insomnia. A search was also undertaken for any study designs that evaluated issues related to adverse events (e.g. dependency and withdrawal symptoms). Full economic evaluations that compared two or more options and considered both costs and consequences including cost-effectiveness, cost-utility analysis or cost-benefit analysis undertaken in the context of high-quality RCTs were considered for inclusion in the review.
RESULTS
Twenty-four studies, involving a total study population of 3909 patients, met the inclusion criteria. These included 17 studies comparing a Z-drug with a benzodiazepine and seven comparing a Z-drug with another Z-drug. The diversity of possible comparisons and the range of outcome measures in the review may be confusing. Outcomes were rarely standardised and, even when reported, differed in interpretation. In addition, variations in assessment and variety in the level of information provided make study comparisons difficult. As a result, meta-analysis has been possible on only a small number of outcomes. However, some broad conclusions might be reached based on the limited data provided. The existing published economic literature in this area is very limited. No relevant economic evaluations were identified for inclusion in the review. The industry submissions did not include detailed evidence of cost-effectiveness. Given the lack of robust clinical evidence, no economic model describing the costs and benefits of the newer hypnotic drugs for insomnia was developed. The systematic review provided in this report suggests that an agnostic approach to cost-effectiveness is required at this stage. In the short-term, no systematic evidence is available concerning significant outcome variations between either the different classes of drugs or between individual drugs within each class. Within this short-term horizon, the one element that does vary significantly is the acquisition cost of the individual drugs.
CONCLUSIONS
The short-acting drugs seem equally effective and safe with minor differences that may lead a prescriber to favour one over another in different patients. There is no evidence that one is more cost-effective than any other. Analysis of the additional costs to the NHS, depending on the rate of change from benzodiazepine prescriptions to Z-drug prescriptions, at current levels of hypnotic prescribing, range from GBP2 million to GBP17 million per year. There are clear research needs in this area; in particular, none of the existing trials adequately compare these medications. It is suggested that further consideration should be given to a formal trial to allow head-to-head comparison of some of the key drugs in a double-blind RCT lasting at least 2 weeks, and of sufficient size to draw reasonable conclusions. We would also recommend that any such trial should include a placebo arm. It should also collect good-quality data around sleep outcomes and in particular quality of life and daytime drowsiness. We do not believe that any formal study of risk of dependency is feasible at present. Finally, the management of long-term insomnia is suggested for further investigation: considering the frequency of this symptom and its recurring course, the short-term trial of medication and lack of long-term follow-up undermine attempts to develop evidence-based guidelines for the use of hypnotics in this condition, or indeed for its whole management.
Topics: Adult; Aged; Cost-Benefit Analysis; Female; Humans; Hypnotics and Sedatives; Male; Middle Aged; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 15193209
DOI: 10.3310/hta8240 -
Current Sleep Medicine Reports Mar 2020Adverse effects of sedative-hypnotic medications on cognition are concerning. Past studies have examined benzodiazepine (BZD) use and cognitive outcomes; however, few...
PURPOSE OF REVIEW
Adverse effects of sedative-hypnotic medications on cognition are concerning. Past studies have examined benzodiazepine (BZD) use and cognitive outcomes; however, few studies have examined newer non-BZD hypnotic agents (nBHs; e.g. zolpidem). This systematic review examined observational studies assessing the association between nBH use and cognitive outcomes.
RECENT FINDINGS
Five studies met eligibility requirements and were included in the review. Most studies did not find an association between nBH use and dementia diagnosis; however, we found no studies assessing other cognitive outcomes such as cognitive performance (e.g., word recall tasks). Characterization of nBH use mostly consisted of incident new use; one study assessed nBH dosing; none examined duration of use. Studies included were of strong quality.
SUMMARY
This review found no association between nBH use and dementia diagnosis, although there is a need for more research on more cognitive outcomes and nBH use patterns.
PubMed: 33457189
DOI: 10.1007/s40675-020-00163-1 -
The International Journal of... Sep 2021Mobility is important for daily life functioning, with particular challenges regarding road safety under pharmacological treatment in patients with a psychiatric disease.
BACKGROUND
Mobility is important for daily life functioning, with particular challenges regarding road safety under pharmacological treatment in patients with a psychiatric disease.
METHODS
According to PRISMA guidelines, a systematic literature search on PubMed database (January 1970 to December 2020) was performed. Primary endpoints were driving performance in on-road tests, driving simulator performance, or psychomotor and visual perception functions assessed to estimate fitness to drive according to legal regulations in patient studies.
RESULTS
Forty studies were identified (1533 patients, 38% female, median age 45 years), of which more than 60% were cross-sectional and open-label trials. Under steady-state medication, 31% (range 27%-42.5%) of schizophrenic or schizoaffective patients under antipsychotics and 18% (range 16%-20%) of unipolar and bipolar patients under antidepressants showed severe impairment in skills relevant for driving. Data point to an advantage of second-generation antipsychotics compared with first-generation antipsychotics as well as modern antidepressants over tricyclic antidepressants with respect to driving. Most patients significantly improved or stabilized in driving skills within 2-4 weeks of treatment with non-sedative or sedative antidepressants. Diazepam significantly worsened driving the first 3 weeks after treatment initiation, whereas medazepam (low dose), temazepam, and zolpidem did not impair driving. In long-term users of sedating antidepressants or benzodiazepines, impairments in on-road tests were not evident.
CONCLUSION
The available evidence suggests that psychopharmacologic medicines improve or at least stabilize driving performance of patients under long-term treatment when given on clinical considerations. To enhance treatment compliance, existing classification systems of medicinal drugs concerning impact on driving performance should also incorporate information about effects of long-term-treatment.
Topics: Adult; Antidepressive Agents; Antimanic Agents; Antipsychotic Agents; Automobile Driving; Benzodiazepines; Female; Humans; Male; Mental Disorders; Middle Aged; Psychomotor Performance
PubMed: 34038545
DOI: 10.1093/ijnp/pyab031 -
PM & R : the Journal of Injury,... Sep 2016
PubMed: 27672987
DOI: 10.1016/j.pmrj.2016.07.262