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PubMed1996

The effect of ondansetron on the pharmacokinetics and pharmacodynamics of temazepam.

The objective of this study was to determine the effects of ondansetron on the pharmacokinetics of temazepam and on pharmacodynamics relevant to its use as oral premedication. Twenty-four healthy volunteers (12 of each sex) were administered the following oral treatments in a randomised, double-blind crossover design: temazepam 20 mg plus placebo; or temazepam 20 mg plus ondansetron 8 mg. Blood samples were taken for plasma temazepam assay at intervals up to 32 h after administration. In addition, a brief battery of psychomotor tests was administered 1 h prior to dosing and 1 and 4 h after dosing. Analysis of the derived pharmacokinetic parameters showed no differences between the treatments described above. Analysis of data from the dynamic measures likewise showed no difference between the treatments. It was concluded that the co-administration of ondansetron did not influence the pharmacokinetics or pharmacodynamic actions of temazepam.

Adult↗
PubMed1986

Saccadic eye movements as a measure of residual effects: temazepam compared with other hypnotics.

Eye movements are classified into two categories: quickly running saccades and smooth pursuit movements. Saccades are fast conjugate eye movements with a preprogrammed direction, amplitude, and speed course; their purpose is to register new objects in the visual field. The duration and velocity of saccadic eye movements are very much dependent on vigilance. Comparisons were made with a number of psychometric tests [d 2 Durchstreichtest (cross out test), Viennese determination apparatus, and flicker fusion frequency] and the velocity of fast eye movements. The results of three separate investigations are presented. Standardization was undertaken in 100 healthy volunteers, 50 male and 50 female subjects aged between 20 and more than 50 years were included. In an open parallel group study, comparisons were made between various hypnotics with different half-lives (temazepam, flunitrazepam, flurazepam, and phenobarbital). There were 10 healthy volunteers in each group, and medication was taken as a single night-time dose for 7 nights. In a double-blind study, temazepam (20 mg/day) was tested against flunitrazepam (2 mg/day). Dosing lasted 7 days. A marked impairment of the saccadic eye movements was observed with flunitrazepam but not with temazepam. Of all the benzodiazepines tested, only temazepam had no influence on the parameters of the saccade test. These results can be explained by temazepam's short half-life and also by the fact that no active metabolites are formed.

Adult↗
PubMed1979

Acute effects of temazepam and nitrazepam on psychomotor skills and memory.

Twelve pretrained students ingested temazepam, nitrazepam, and placebo, each double blind at one-week intervals in randomized order. Reactive and co-ordinative skills and critical flicker fusion were measured before each drug intake and 1, 2, 3, 6 and 8 hours after it. Short-term memory and paired association learning were measured at 1, 3 and 8 hours. The psychomotor responses to drugs were modified by a sequence effect (not at zero tests) which effect varied depending on the drug and parameter. In multivariance analysis it was included to reveal drug effects. Nitrazepam 10 mg increased reaction and co-ordination errors and also impaired learning and memory. Temazepam 10 mg impaired co-ordinative skills; on a whole it differed from nitrazepam but hardly from placebo. Temazepam 20 mg impaired co-ordination, and learning and memory. Both temazepam 20 mg and nitrazepam were experienced sedative. All drug effects were clearest during the first 3 hours, nitrazepam also impaired learning at 8 hours. Temazepam 20 mg seems suitable as a hypnotic.

Adult↗
PubMed2003

Errors in performance testing: a comparison of ethanol and temazepam.

Both ethanol and benzodiazepines impair psychomotor function. Previous work has suggested that ethanol may have a greater effect on errors while benzodiazepines may cause greater slowing, but this has not been tested in a direct comparison. We assessed the effects of ethanol, at blood concentrations of approximately 80-100 mg/100 ml, compared to two doses of temazepam (20 mg and 30 mg) on psychomotor speed and accuracy and on long-term memory. Sixteen healthy volunteers (eight male, aged 20-25 years) took part in a four-period, placebo-controlled cross-over study. Performance was evaluated using analysis of covariance (critical significance level, p = 0.05) comparing the areas under the response-time curves. Performance on a psychomotor maze showed an almost complete dissociation, with ethanol leading to a substantial and significant increase in errors with little effect on speed, while temazepam slowed performance with no significant change in accuracy. Other tasks showed a similar pattern, but the dissociation was less complete. Handwriting size was substantially increased by ethanol, but not by temazepam. Information processing capacity and long-term memory formation were reduced by a similar amount both for ethanol and 30 mg temazepam. The faster, more error-prone, behaviour on ethanol than with a similarly impairing dose of temazepam has clear implications for the relative potential of the two drugs to contribute to accidents. The results are also important in understanding the differential effects of drugs with different mechanisms of action on human performance.

Adult↗
PubMed1981

Temazepam: a review of its pharmacological properties and therapeutic efficacy as an hypnotic.

Temazepam is a benzodiazepine drug which is a minor metabolite of diazepam. In clinical studies using subjective evaluation methods it was effective for maintaining sleep and increasing total sleep time. However, sleep laboratory studies did not show a significant effect on some sleep parameters, especially sleep induction. Temazepam has a relatively short half-life (about 5 to 11 hours, longer in some subjects and in the elderly), and no active metabolites of clinical importance, and thus may be considered more suitable for use as an hypnotic than longer acting drugs such as diazepam, nitrazepam or flurazepam when residual sedative effects the next day are not desirable. Indeed, few residual effects on morning performance appear to occur with usual single doses of temazepam, although at the upper end of the recommended dosage range (30 mg or more) some evidence of impaired psychomoter and cognitive function in the morning has been reported. Whether or not temazepam is likely to produce "hangover" with repeated night-time administration needs further clarification. While a call for a large number of controlled trials may not be justifiable in evaluating a new hypnotic, a few well designed additional comparative studies in insomniac subjects are needed to assess adequately the relative merits of temazepam (particularly with regard to sleep onset) compared with other benzodiazepine hypnotics, especially those which are short- or intermediate-acting.

Animals↗
PubMed2004

The effects of restricting publicly subsidised temazepam capsules on benzodiazepine use among injecting drug users in Australia.

OBJECTIVE: To assess the effect of a restriction on publicly subsidised temazepam 10 mg capsules upon the injection of benzodiazepines by injecting drug users (IDUs). DESIGN AND PARTICIPANTS: Cross-sectional study of regular IDUs targeting periods before and after the policy change. Analysis of prescription data, including time-series analysis. SETTING: Drug services in the capital cities of New South Wales, Victoria, Tasmania, Queensland and the Northern Territory. MAIN OUTCOME MEASURES: Changes in prescriptions and patterns of benzodiazepine use; harms associated with benzodiazepine use. RESULTS: There was a decrease in temazepam 10 mg capsule prescriptions and a corresponding increase in temazepam 10 mg tablet prescriptions after the policy change. IDU survey data suggested that IDUs continued to inject benzodiazepines and temazepam capsules. The frequency of the injection of capsules after the restriction appeared similar to that before the policy change. There was no change in the frequency of injection of tablets. Most IDUs reported obtaining their benzodiazepines from doctors, with substantial proportions obtaining capsules even after the restriction. About half the IDUs reported purchasing benzodiazepines on the street. Most IDUs who injected benzodiazepines reported injection-related problems. CONCLUSION: Limiting the prescribing of temazepam capsules may have reduced their injection by some IDUs, but additional strategies are needed to reduce the misuse among this group. These may include further restriction of capsule preparations, continued education of doctors and IDUs, and the examination of prescribing practices of individual doctors.

Adolescent↗
PubMed1990

Dose effects of temazepam in transient insomnia.

A transient insomnia model, the "first night" effect in the sleep laboratory, was used to assess the dose range for the hypnotic and sleep stage effects of temazepam. 201 healthy, normal subjects (97 men and 104 women), 21 to 49 years old, with no sleep complaints were studied. Each was randomly assigned to receive either placebo, 7.5, 15, or 30 mg temazepam hard gelatin capsules (Restoril) administered double-blind 30 min before bedtime on their first night in the sleep laboratory. Over the 8-h polysomnogram total sleep time and sleep efficiency increased significantly in a linear fashion with increasing doses of temazepam. Sleep tendency was significantly reduced by increasing doses again in a linear manner. Wake time during the sleep period was reduced significantly only by the higher dose. The percentage of stage 1 sleep was reduced and the percentage of stage 2 sleep was increased, each linearly with increasing doses. These data are the first to demonstrate the hypnotic effects of a 7.5 mg dose of temazepam and also support previous studies of 15 and 30 mg temazepam administered to chronic insomniacs. They also illustrate the utility of the "first night" effect as a model of transient insomnia.

Adult↗
PubMed1982

Double-blind evaluation of temazepam, flurazepam, and placebo in geriatric insomniacs.

The efficacy and safety of temazepam (30 mg) were compared with the efficacy and safety of flurazepam hydrochloride (30 mg) and placebo in a four-day, double-blind study in 75 geriatric convalescent-home patients with insomnia. The efficacy and safety profiles of the two active drugs were similar. Patients treated with temazepam, however, reported significantly less drug hangover both on awakening and during the entire day after each night of treatment than did patients receiving flurazepam or placebo. The difference between temazepam and flurazepam was probably due to the drugs' markedly different half-lives, temazepam's mean half-life being ten hours compared with 65.5 hours for the active metabolite of flurazepam. It is well recognized that the elderly may be especially sensitive to the adverse effects associated with the accumulation of the long-acting metabolite of flurazepam. Since temazepam has no active metabolites and minimal accumulation, it is a particularly appropriate hypnotic for use in geriatric patients.

Aged↗
PubMed1984

Is temazepam an accumulating hypnotic?

Ten healthy volunteers aged 22 to 30 years received a single 20-mg oral dose of temazepam. Serum temazepam concentrations were measured by gas chromatography at multiple times during the next 48 hours. Mean kinetic variables were: volume of distribution, 1.45 liter/kg; elimination half-life, 8.6 hours; total clearance, 2.33 ml/min/kg. The subjects then received 20 mg temazepam once daily for seven consecutive days. Serum concentrations were measured just prior to each dose and at multiple time points after the last dose. Predose serum levels increased during the first three days of dosage, then increased no further. Mean values measured 24 hours after doses 1 through 6, respectively, were 33, 43, 55, 47, 53, and 51 ng/ml. Based on the area under the serum concentration curve after the last dose compared with that after the first dose, the mean accumulation ratio was 1.32, which was significantly greater than unity. The extent of accumulation was consistent with that predicted from the single-dose study. Postdosage washout half-life averaged 10.2 hours. Thus, temazepam has a pharmacokinetic profile of an intermediate half-life benzodiazepine that produces an intermediate degree of accumulation with multiple dosage.

Absorption↗
PubMed1983

Biliary excretion of [14C]temazepam and its metabolites in the rat.

The excretion of temazepam and its N-desmethyl metabolite, oxazepam, and their respective O-conjugates was examined following a single intravenous dose of [14C]temazepam to two groups of bile fistula rats, with and without bile replenishment to the animals via duodenal cannulae. During an 8-hr collection period, the two groups produced virtually identical bile volumes, and there were no significant differences between them in the amount of total radioactivity, free temazepam, or the identified metabolites in the bile, as determined by TLC and liquid scintillation counting. Elimination of the radioactive dose was rapid during 0-8 hr, with a half-life of approximately 1 hr. Approximately 85-90% of the administered radioactivity was recovered in the bile: less than 1% as free temazepam, 3% as oxazepam, and approximately 10% as their O-conjugates.

Animals↗
PubMed1988

Determination of temazepam and related compounds in capsules by high-performance liquid chromatography.

A reversed-phase, high-performance liquid chromatographic assay method is described for temazepam hard gelatin and soft gelatin capsule analysis. The method is simple, specific, accurate, fast, and stability indicating. A reversed-phase octylsilane (C8) column with a mobile phase composed of methanol:1% acetic acid and detection at 254 nm separated sulfanilamide (internal standard), temazepam, synthetic precursor, and possible degradation products. Detector responses showed linearity to temazepam concentrations over the range 0.075-0.60 mg/mL (r = 0.9999). Mean recovery of temazepam added to capsule excipients was 100.3%. Mean assay results for 15- and 30-mg hard gelatin capsules were 101.5 and 101.3%, respectively. Mean assay results for 10- and 20-mg soft elastic gelatin capsules were 101.1 and 101.5%, respectively.

Anti-Anxiety Agents↗
PubMed1994

Temazepam 7.5 mg: effects on sleep in elderly insomniacs.

Temazepam, 7.5 mg was evaluated in the sleep laboratory in 8 elderly insomniacs, using a 14-night protocol (4 placebo-baseline nights, 7 drug nights, and 3 placebo-withdrawal nights). With short-term use temazepam was found to be effective, producing a significant improvement in total wake time from baseline (100 vs. 145 min). With continued drug administration, total wake time remained below baseline but not significantly so (125 vs. 145 min). During drug administration, there were no major CNS and behavioral adverse effects reported such as daytime sedation, memory impairment or hyperexcitability (daytime anxiety). Following drug withdrawal, there was no significant increase in wakefulness, i.e., no rebound insomnia (150 vs. 145 min). In summary, temazepam, 7.5 mg is effective in elderly subjects with short-term use and has a minimum of adverse effects. Use of hypnotic drugs is an adjunctive therapy which should be for a short-term period with subsequent short-term intermittent use as needed. Because of its low propensity for producing rebound insomnia, temazepam can be effectively used in this manner.

Aged↗
PubMed1983

An investigation into the interaction between ethanol at low doses and the benzodiazepines nitrazepam and temazepam on psychomotor performance in normal subjects.

Ten healthy male volunteers received, in randomized order, temazepam 20 mg, nitrazepam 5 mg or placebo in combination with ethanol 0.1, 0.2 or 0.4 g/kg. Psychomotor tests were performed at regular intervals over 8 h. Ethanol alone at 0.4 g/kg significantly showed simple reaction time for between 30 and 60 min, whereas nitrazepam (5 mg) or temazepam (20 mg) plus the placebo alcohol dose (0.1 g/g) had no significant effect. The benzodiazepines and ethanol (0.2 and 0.4 g/kg) in combination showed no potentiation or prolongation of action. Both ethanol and the two benzodiazepines significantly reduced critical flicker detection in themselves and, in combination, had additive effects. Only nitrazepam and temazepam produced decreases in performance in the code substitution (DSST) test, and the time course of action of nitrazepam was markedly longer than that of temazepam. Ethanol alone had no detectable effect on immediate recall, prompted recall, learning, or word recognition tests. Both benzodiazepines reduced immediate and prompted recall and nitrazepam, in addition, reduced word recognition ability. It is concluded that the spectrum of CNS depressant actions of ethanol and the benzodiazepines are different and that there is no evidence of a potentiation or prolongation of their effects by concomitant administration of the doses used in the present study.

Adolescent↗
PubMed1984

A study of the effects of zimelidine on the pharmacokinetics and pharmacodynamics of temazepam in healthy volunteers.

In this double-blind two-period crossover study, ten healthy volunteers received either 200 mg zimelidine each morning for 5 days, or placebo on the same schedule. On day 5 they received 20 mg temazepam 2 h after zimelidine or placebo. A battery of psychometric tests and subjective measurements was carried out on days 4 and 5. Blood samples were collected on day 5 for pharmacokinetic analysis of temazepam. All the measures of psychomotor performance showed the effects of temazepam, as did two of the subjective measures, the "alert/drowsy" and "steady/dizzy" visual analogue scales. No effect of zimelidine alone on performance or subjective state was seen. Zimelidine showed no discernible interaction with the effects of temazepam as assessed by subjective reports, by psychomotor tests, or by pharmacokinetic analysis.

Adult↗
PubMed1984

Objective and subjective assessment of hangover during subacute administration of temazepam and nitrazepam to healthy subjects.

Fourteen, healthy students volunteered for a double-blind, cross-over trial of temazepam 20 mg (soft gelatine capsule), nitrazepam 10 mg (uncoated tablet) and placebo in matched formulations, single doses of each being given for 10 nights with a three-week wash-out period between each treatment. Residual drug effects were measured objectively (psychomotor skills) and subjectively (visual analogue scales) in the morning and afternoon of Days 0 (before the first tablet), 1 and 10. The subjects also recorded various events during each treatment period. Serum benzodiazepine concentrations were bioassayed in blood samples taken after the last assessment. Both benzodiazepines shortened sleep latency during the first few nights, and nitrazepam prolonged the duration of sleep. The residual effect of drowsiness was noted during the nitrazepam period, whilst temazepam proved less sedating. The 'morning after' effect was a subjective observation and not an objective measurement. The learning effect interfered with the complex objective assessments, and simple measurement of exophoria with the Maddox wing test provided the clearest objective evidence of drug effects. On Day 10 residual concentrations of nitrazepam were detectable in the serum whereas the level of temazepam was found to be low or negligible. It is concluded, that temazepam 20 mg in a soft gelatine capsule is a suitable hypnotic for subjects whose daily work requires constant alertness.

Activity Cycles↗
PubMed2000

Effect of zopiclone and temazepam on sleep EEG parameters, psychomotor and memory functions in healthy elderly volunteers.

RATIONALE: The increased prevalence of sleep disturbance in old age is accompanied by a higher prescription rate of hypnotics, predominantly benzodiazepines in the elderly. In young volunteers zopiclone exerts a beneficial effect on sleep continuity without suppression of SWS and REM sleep; psychomotor performance and vigilance seemed to be less impaired than under classical benzoediazepines. OBJECTIVE: The present study investigates the effects of zopiclone on sleep EEG and cognitive performance in comparison to temazepam and placebo in the elderly population. METHODS: Single oral doses of zopiclone (7.5 mg), temazepam (20 mg) and placebo were administered in a randomized double-blind, completely counterbalanced cross-over design to 12 healthy elderly men and women (65.9 +/- 3.6 years, range 60-70 years). On each of the 3 study nights a sleep EEG was registered from 10 p.m. to 6.30 a.m. and cognitive performance tests were applied at 8 p.m., 2 a.m. (when subjects were awake for 30 min), 7 a.m. and 9 a.m. RESULTS: After zopiclone treatment, sleep continuity had significantly improved and sleep stage 4 was increased compared to temazepam and placebo. In addition, both active substances significantly reduced REM density. Neither active compound substantially altered psychomotor and memory performance. CONCLUSIONS: Zopiclone and temazepam can be considered as effective hypnotics in elderly subjects when administered in that dosage. The superiority of zopiclone on sleep architecture may be related to a more specific action of zopiclone at the GABA-A benzodiazepine receptor complex. The suppression of REM density by both compounds and their subtle effects on cognition may reflect a GABAergic mediated reduction of cholinergic neuro-transmission.

Aged↗
PubMed2004

Zolpidem is not superior to temazepam with respect to rebound insomnia: a controlled study.

This randomised controlled trial was conducted to compare zolpidem to an equivalent dose of temazepam with respect to subjective rebound insomnia after cessation of 4 weeks of treatment in chronic insomnia (zolpidem 10 mg, n=79; temazepam 20 mg, n=84). Both agents improved total sleep time (TST) as well as sleep onset latency (SOL) significantly during the 4 treatment weeks. Prevalence rates for rebound insomnia, defined as a worsening of TST or SOL of more than 40% compared to baseline, were 27% for TST and 53% for SOL in the Zolpidem condition and 26% and 58%, respectively, in the temazepam condition. No significant differences were found between both agents with respect to rebound insomnia, nor with respect to their efficacy or safety. We conclude that in clinical practice zolpidem has no advantages over temazepam with respect to rebound insomnia.

Adolescent↗
PubMed1992

Effects of temazepam on saccadic eye movements: concentration-effect relationships in individual volunteers.

Saccadic eye movements were analyzed after single oral doses of 20 mg temazepam and placebo in a randomized, double-blind crossover study in eight healthy volunteers. For an optimal evaluation of concentration-effect relationships, 18 blood samples and 43 effect measures were obtained over 33 1/2 hours. After placebo, saccadic peak velocity decreased within the first hour, with average values remaining 6.2% to 12.1% below baseline up to 15 hours after intake. After temazepam, significant changes in peak velocity occurred for 5 hours, with maximum decreases averaging 29.2% (95% confidence interval, 10.0 to 37.2). The apparent duration of effects ranged from 3 to 9 hours in individual subjects. Linear concentration-effect relationships were demonstrated for peak velocity, with individual slopes ranging from -0.11 to -0.46 deg/sec.(ng/ml)-1 (average r = -0.82, all p < 0.01). Differences in protein binding of temazepam did not account for the approximate fourfold variability in individual sensitivities to temazepam. By increasing the frequency of measurements, the accuracy of pharmacodynamic evaluations was clearly enhanced in this study.

Adult↗