Quazepam (Quazepam) - Summary

QUAZEPAM SUMMARY

QUAZEPAM contains quazepam, a trifluoroethyl benzodiazepine hypnotic agent.

QUAZEPAM^® (quazepam) is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of QUAZEPAM has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of QUAZEPAM has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of QUAZEPAM Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.

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NEWS HIGHLIGHTS

Published Studies Related to Quazepam

Effects of itraconazole on the plasma kinetics of quazepam and its two active metabolites after a single oral dose of the drug. [2003]
The effects of itraconazole, a potent inhibitor of cytochrome P450 (CYP) 3A4, on the plasma kinetics of quazepam and its two active metabolites after a single oral dose of the drug were studied.

Feasibility of an every-other-night regimen in insomniac patients: subjective hypnotic effectiveness of quazepam, triazolam, and placebo. [1993]
CONCLUSION: The efficiency of alternate-night therapy with quazepam should be

Quazepam versus triazolam in patients with sleep disorders: a double-blind study. [1993]
Quazepam, a recently introduced long-half-life benzodiazepine, seems to have a more specific hypnotic activity and a physiological mechanism of action. The present study evaluated clinical efficacy and eventually rebound symptoms after the treatment with quazepam and triazolam... On the contrary, triazolam turned out to be just a hypnoinducent drug with higher risks of rebound effects after withdrawal.

Objective measurements of daytime sleepiness and performance comparing quazepam with flurazepam in two adult populations using the Multiple Sleep Latency Test. [1991]
Daytime residual drowsiness and psychomotor performance were assessed for two long half-life benzodiazepines, quazepam and flurazepam, in two randomized, parallel, and double-blind studies in insomniacs... Thus, quazepam 15 mg produces less daytime somnolence and fewer psychomotor performance decrements than does flurazepam.

The effects of alprazolam, quazepam and diazepam on saccadic eye movements, parameters of psychomotor function and the EEG. [1990]
The effects of a single oral dose of alprazolam (1 mg), quazepam (15 mg) and diazepam (10 mg) on the peak saccadic velocity (PSV) of saccadic eye movements (SEM), the Sternberg memory scanning and choice reaction time (SMS-CRT), critical flicker fusion frequency (CFFF), spectral analysis of the EEG and a mood scale were assessed in 9 healthy volunteers in a double-blind, placebo-controlled cross-over study.

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Clinical Trials Related to Quazepam

Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons [Completed]
Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as cognitive functions, which in turn could result in lethal incidents including falls especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail population. In this 8-week open-label study, we examined changes in motor and cognitive functions following the discontinuation of BZD hypnotics in older persons. OBJECTIVES & HYPOTHESES 1. Primary Objective The primary objective is to examine the feasibility of discontinuing BZD-derivative hypnotics in older people. 2. Secondary Objectives 1. One of the secondary objectives is to examine the magnitude of discontinuing BZD-derivative hypnotics in the stability of body. 2. Another secondary objective is to examine the magnitude of discontinuing BZD-derivative hypnotics in cognitive function. Hypotheses 1. More than 80% of the participants will complete and tolerate all the study procedures. 2a. Participants will show an improvement in the stability of body. 2b. Participants will show an improvement in the cognitive function globally as well as specifically in attention.

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes [Active, not recruiting]
This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.

Distal Radial Fractures in the Late Middle Aged [Not yet recruiting]
Background: Wrist fractures are a common injury among people aged 55-70. The radius is one of the bones making up the wrist joint, and is typically the site of injury in a broken wrist. Methods of treating a broken radius include placing the wrist in a cast for 6 weeks (conservative management) or receiving surgery. Surgery allows for earlier movement of the wrist and return to activity, while being placed in a cast is less invasive than surgery. Surgery to fix these fractures has become more common; however there is little agreement about who should receive surgery and who should be placed in a cast to heal. The goal of this study is to compare outcomes between people aged 55-70 who have broken their wrist and had surgery, and those who received a cast. Procedures: Participants in this study will be randomly assigned to one of two study groups within 1 week of injury at their first clinic visit with the surgeon. Patients in Group A (surgical management) will continue with casting for a total of 6 weeks, as indicated by the surgeon. Patients in Group B (conservative management) will receive surgery, and the attending surgeon will determine the best fracture fixation method for the wrist. The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after the initial injury. At each assessment, the wrist will be examined and participants will be asked to fill in some questionnaires about health, pain, wrist function, and satisfaction with the wrist. An X-ray will also be performed on the wrist to assess bone healing. Information from each visit will be used to determine how participants are doing and to compare the 2 study groups.

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in participants with gout.

Santyl Applications to Diabetic Foot Ulcers [Recruiting]
The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.

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