Double‐blind Evaluation of the Safety and Hypnotic Efficacy of Temazepam in Insomniac Outpatients

Heffron, William M.; Roth, Paul A.

doi:10.1111/j.1365-2125.1979.tb00460.x

Cited by 20 publications

(14 citation statements)

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“…The effect of temazepam was similar to that of flurazepam in its efficacy and its effect on slow wave sleep (Dement, Carskadon, Mitler, Phillips & Zarcone, 1978), but flurazepam also suppressed REM sleep (Kales, Kales, Bixler & Slye, 1971;Kales, Kales, Bixler & Scharf, 1975). In outpatients with insomnia, Heffron & Roth (1979) and Fillingim (1979) have found that temazepam 30 mg increased total sleep time, reduced difficulty in falling asleep and improved sleep with less awakenings, particularly in the early morning.…”

Section: Effectiveness In Insomniamentioning

confidence: 97%

The use of short‐ and long‐acting hypnotics in clinical medicine.

Nicholson¹

1981

Brit J Clinical Pharma

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1 Activity of short‐ and long‐acting benzodiazepines is reviewed with reference to pharmacokinetics and residual sequelae, and to efficacy and adverse effects. 2 Some benzodiazepines may not lead to obvious effects on performance, such as nordiazepam and clobazam, and the persistence of residual sequelae may not relate obviously to elimination half‐lives (as with diazepam and possibly flunitrazepam). However, benzodiazepines with mean half‐lives less than 8 h may have residual sequelae, whereas hypnotics with mean half‐lives greater than 16 h are likely to lead to impared performance and/or anxiolytic effects the next day. 3 Potassium chlorazepate 15 mg, with its long‐ acting metabolite nordiazepam, would seem to be the drug of choice for insomnia secondary to anxiety. For the insomniac without significant psychopathology, temazepam 10‐20 mg, triazolam 0.125‐0.25 mg and for occasional use, diazepam 5‐10 mg, provide the initial approach. Flurazepam hydrochloride 15‐30 mg, nitrazepam 5‐10 mg and flunitrazepam 1 mg and above, have persistent residual effects and should be reserved for refractory patients, and for those in whom some impairment of performance the next day would be acceptable. 4 There is little or no evidence to suggest that the proper use of the short‐acting hypnotics, triazolam and temazepam, leads to a worsening of sleep on withdrawal. However, some benzodiazepines may lead to disturbances of sleep and/or rebound insomnia, and nitrazepam and flunitrazepam may be implicated.

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Section: Effectiveness In Insomniamentioning

confidence: 97%

The use of short‐ and long‐acting hypnotics in clinical medicine.

Nicholson¹

1981

Brit J Clinical Pharma

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“…Temazepam in the hard capsule formulation available in the United States has been shown in double-blind, placebo controlled, clinical trials to relieve complaints of difficulty falling asleep, frequent awakenings, and early morning awakenings (Fillingim, 1979(Fillingim, , 1982Heffron & Roth, 1979). However, three sleep laboratory studies, while demonstrating temazepam's overall hypnotic efficacy, did not confirm the perception of reduced sleep latency found in the clinical trials (Bixler et al, 1978;Mitler et al, 1979;Vogel, 1983, personal communication).…”

Section: Introduction Methodsmentioning

confidence: 82%

Temazepam's efficacy in patients with sleep onset insomnia.

Roehrs¹,

Lamphere

Paxton

et al. 1984

Brit J Clinical Pharma

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The hypnotic efficacy of temazepam capsules (30 mg) was studied in twelve patients who had objective polysomnographic evidence of sleep onset insomnia. Patients slept in the laboratory, retiring at their usual bedtime after taking placebo or temazepam 30 min earlier, and were monitored for 8 h using standard polysomnographic techniques. Acute (nights 5‐7) and chronic (nights 11‐13) temazepam improved the sleep of these patients by reducing sleep latency and increasing sleep time compared to the placebo baseline (nights 2‐4). No detrimental effects on daytime function the following morning were observed using questionnaires and objective tests of performance. No consistent evidence of disturbed sleep after discontinuation of treatment was obtained over three recovery nights.

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“…Outcomes included patient-reported estimates of SL, TST, NOA and QOS. Heffron 115 reported on 55 "insomnia outpatients" who received temazepam 30 mg or placebo in parallel groups for four nights. Subjects reported SL, TST, NOA and QOS.…”

Section: -112mentioning

confidence: 99%

“…Two studies 114,115 reported subjective NOA at 30 mg. They found −1.0 and −1.24 awakenings, respectively, compared to placebo.…”

Section: Number Of Awakeningsmentioning

confidence: 99%

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

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Introduction:The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations:The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources.1. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 2. We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 3. We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 4. We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance in...

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Double‐blind Evaluation of the Safety and Hypnotic Efficacy of Temazepam in Insomniac Outpatients

Cited by 20 publications

References 0 publications

The use of short‐ and long‐acting hypnotics in clinical medicine.

The use of short‐ and long‐acting hypnotics in clinical medicine.

Temazepam's efficacy in patients with sleep onset insomnia.

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

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