Comparison of Residual Effects and Efficacy of Zolpidem, Flurazepam and Placebo in Patients With Chronic Insomnia

Scharf, Martin B.; Schweitzer, Paul; Fleming, J. E. E.; Moldofsky, Harvey; Niño-Murcia, German; Radonjić, D; Ochs, Raymond S.; Kaffeman, M.

doi:10.1097/00002826-199202001-00529

Cited by 4 publications

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“…On the contrary, objective and subjective measures of sleepiness revealed no difference between zolpidem and placebo. Similar results have been reported by Scharf et al (1992) in 14 1 insomniac patients double-blind treated during two consecutive nights with zolpidem 10 or 20 mg, flurazepam 30 mg or placebo: flurazepam induced more daytime sedative effects than zolpidem or placebo.…”

Section: Studies With Placebo and Benzodiazepine Controlsupporting

confidence: 88%

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Short-term safety profile of zolpidem: objective measures of cognitive effects

DeClerk

Bisserbe

1997

Eur. psychiatr.

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The potential effects of zolpidem, a non-benzodiazepine hypnotic, on cognitive and psychomotor functions have been explored in more than 30 placebo controlled studies, and in many cases in comparison with benzodiazepine reference hypnotics (ie flunitrazepam, nitrazepam, triazolam). Daytime impact of drug administration on alertness has been studied with the Multiple Sleep Latency Test, and no significant clinical impairment has been found after zolpidem 5 to 10 mg, unlike benzodiazepines. Evaluation of the effects of zolpidem on attention and psychomotor skills (critical flicker fusion threshold, substitution or copying tests, choice reaction times or driving tests, etc) indicate that zolpidem at recommended doses (5 mg in elderly and 10 mg in adults) is unlikely to produce significant detrimental residual effects on daytime vigilance, concentration and coordination performances on the morning after intake. In accordance with its pharmacokinetic and pharmacodynamic properties, the effects on zolpidem on memory functions were limited to the first hours after administration and no significant difference was observed between zolpidem (5–10 mg) and placebo 6 hours after administration; longer memory impairment was observed with flunitrazepam or triazolam. Various groups of subjects were included in these studies, both young adults and elderly subjects, healthy volunteers and insomniac patients, and duration of treatment varied between one single dose and 28 days of repeated intake. In conclusion, experimental evidence demonstrates a satisfactory safety profile of zolpidem (5–10 mg) on daytime cognitive functions as compared to other hypnotics.

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Section: Studies With Placebo and Benzodiazepine Controlsupporting

confidence: 88%

“…The impact of zolpidem on subsitution or copying tests has also been compared to flurazepam, triazolam and diazepam (Morselli et al, 1988;Bensimon et al, 1990;Nicholson and Pascoe 1986;Scharf et al, 1992). Only flurazepam was found to have a significant effect on performance in DSST.…”

Section: Vigilance and Attentionmentioning

confidence: 99%

Short-term safety profile of zolpidem: objective measures of cognitive effects

DeClerk

Bisserbe

1997

Eur. psychiatr.

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“…The comparative ef®cacy, safety, residual effects and performance of zolpidem have been established for: bretazenil (Gieschke et al, 1994), diazepam (Maillard et al, 1992, doxylamine Schadeck et al, 1996), unitrazepam (Emeriau et al, 1988;Maggioni and Frattola, 1988;Guieu et al, 1991;Vermeeren et al, 1991;Guazzelli et al, 1993;Murciano et al, 1993;Genton et al, 1994), urazepam (Cirignotta et al, 1988Scharf et al, 1992;Fleming et al, 1995;Mendelson et al, 1995a), lorazepam (Lebrault et al, 1989) lormetazepam (Lund et al, 1988Cluydts et al, 1995), midazolam (Praplan Pahud et al, 1990) nitrazepam (Uchiumi et al, 1994), oxazepam (Coupez et al, 1988), RO 41±3696 (Dingemanse et al, 1995), temazepam (Ochs et al, 1992;Gremion et al, 1992;Gengo et al, 1995;Rush and Grif®ths, 1996), trazodone , triazolam (Louvel et al, 1988;Nagakome et al, 1991;Takasawa et al, 1991;Balkin et al, 1992;Ochs et al, 1992;Ferrillo et al, 1992;Berlin et al, 1993;Kanno et al, 1993;Pagot et al, 1993;Roger et al, 1993;Steens et al, 1993;Monti et al, 1994;Uchiumi et al, 1994;Greenblatt et al, 1996;Rush and Gif®...…”

Section: Comparative Studies Versus Other Sedatives and Hypnoticsmentioning

confidence: 99%

“…Various kinds of subjects were included in these studies: young adults, the elderly, healthy volunteers, and insomniac patients; there were also different durations of treatment, ranked between one single dose and 15 daily doses, being tested. Scharf et al (1992) used the Digit±Symbol Substitution Test (DSST) to compare residual effects of zolpidem and BZD.…”

Section: Impact On Memory and Performancementioning

confidence: 99%

The safety and tolerability of zolpidem — an update

Darcourt¹,

Pringuey

Sallière³

et al. 1999

J Psychopharmacol

112

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Zolpidem belongs to a new class of hypnotic agents, chemically distinct from the pre-existing ones, and has a unique neuropharmacological profile. It induces sedative/hypnotic effects in rodents at doses much lower than those for anticonvulsant and myorelaxant activities. Clinically, zolpidem is indicated for the short term treatment of insomnia. It has a short half-life (2.4h), with no active metabolite, and does not accumulate during repeated administration. The pharmacokinetic profile associated with the absence of active metabolites is consistent with the short duration of action and absence of residual effects that have been observed. Polysomnographic experience indicates that zolpidem induces a sleep pattern which is similar to that of physiological sleep, and which produces either no or only minimal effects on sleep architecture after abrupt discontinuation. Aspects of the general safety of zolpidem have been studied in data obtained from healthy volunteers and patients, both adult and elderly, during its clinical development and in post-marketing experience. Zolpidem appears to be well-tolerated in adults and in the elderly, when administered in accordance with prescribing instructions. The available data indicate that, in these circumstances, the risk of abuse or dependence is minimal.

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Efficacy of zolpidem in insomnia

et al. 1997

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SummaryThe efficacy of zolpidem, a non benzodiazepine hypnotic agent with a short elimination half life, was reviewed, analysing more than 50 international clinical trials published since 1986. The hypnotic activity of zolpidem has been explored in different patient populations including normal volunteers, general practice outpatients and psychiatric out- or in-patients with varying sleep disorders; both transient and chronic. Assessment methods used have included objective and subjective measures of hypnotic efficacy for different treatment durations, with results confirming that 10 mg is superior to placebo. Zolpidem was shown to be superior in most trials on sleep parameters such as total sleep time, sleep onset latency and nocturnal awakenings, but total REM sleep and REM latency were usually unmodified. Zolpidem maintained normal sleep physiology as demonstrated by the preservation of slow wave stages and no, or minimal, effects on sleep architecture after abrupt discontinuation. Consequently, 10 mg is the recommended dose for the short-term treatment of insomnia in the non-elderly; in elderly patients 5 mg has been shown to be effective at inducing sleep whilst giving an optimum safety profile.

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Comparison of Residual Effects and Efficacy of Zolpidem, Flurazepam and Placebo in Patients With Chronic Insomnia

Cited by 4 publications

References 0 publications

Short-term safety profile of zolpidem: objective measures of cognitive effects

Short-term safety profile of zolpidem: objective measures of cognitive effects

The safety and tolerability of zolpidem — an update

Efficacy of zolpidem in insomnia

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