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Prosom (Estazolam) - Summary

 
 



PROSOM SUMMARY

PROSOM™
(estazolam tablets)
CS-IV

ProSom (estazolam), a triazolobenzodiazepine derivative, is an oral hypnotic agent. Estazolam occurs as a fine, white, odorless powder that is soluble in alcohol and practically insoluble in water. The chemical name for estazolam is 8-chloro-6-phenyl-4H-s-triazolo[4,3-(alpha)] [1,4]benzodiazepine. The empirical formula is C16H11ClN4.

ProSom (estazolam) is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that ProSom administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY).

Because insomnia is often transient and intermittent, the prolonged administration of ProSom is generally neither necessary nor 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.

There is evidence to support the ability of ProSom to enhance the duration and quality of sleep for intervals up to 12 weeks (see CLINICAL PHARMACOLOGY).


See all Prosom indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Prosom (Estazolam)

Sleep Disorders: Insomnia, Sleep Apnea, and More
Source: MedicineNet Jet Lag Specialty [2016.08.22]
Title: Sleep Disorders: Insomnia, Sleep Apnea, and More
Category: Slideshows
Created: 7/23/2010 2:39:00 PM
Last Editorial Review: 8/22/2016 12:00:00 AM

Tips to Avoid Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2016.06.24]
Title: Tips to Avoid Insomnia
Category: Slideshows
Created: 12/10/2008 12:00:00 AM
Last Editorial Review: 6/24/2016 12:00:00 AM

Insomnia Quiz: Test Your Sleep Hygiene IQ
Source: MedicineNet Sleep Aids And Stimulants Specialty [2016.06.07]
Title: Insomnia Quiz: Test Your Sleep Hygiene IQ
Category: MedicineNet Quiz
Created: 6/6/2016 12:00:00 AM
Last Editorial Review: 6/7/2016 2:46:56 PM

Insomnia: 20 Tips for Better Sleep
Source: MedicineNet Sleep Aids And Stimulants Specialty [2016.06.07]
Title: Insomnia: 20 Tips for Better Sleep
Category: Slideshows
Created: 10/1/2014 12:00:00 AM
Last Editorial Review: 6/7/2016 12:00:00 AM

Why white matter matters in insomnia
Source: MRI / PET / Ultrasound News From Medical News Today [2016.04.08]
Insomnia can strike anyone at any time, yet the neurology involved is still poorly understood. A new study examines the role of white matter in this exhausting and cryptic malady.

more news >>

Published Studies Related to Prosom (Estazolam)

[Analysis on somnipathy related factors in elderly patients with stroke and comparative study on the efficacy of treatment by traditional Chinese medicine and by estazolam] [2009.03]
OBJECTIVE: To analyze the somnipathy related factors in elderly patients with stroke and to compare effects of traditional Chinese medicine and estazolam on sleep and the followed nervous function... CONCLUSION: The occurrence of somnipathy in stroke patients was closely related with the property and site of lesion, and the neurological deficit degree of patients. Better sleep is surely favorable for recovery of the nervous function, and TCM shows a favorable efficacy on somnipathy.

Comparative bioavailability of two estazolam tablet formulations in Indonesian healthy volunteers. [2008]
AIM: To compare the bioavailability of two estazolam (CAS 29975-16-4) tablet formulations (Estalin 2 mg tablets as test formulation and 2 mg tablets of the originator product as reference formulation)... CONCLUSION: These results indicate that two formulations of estazolam are bioequivalent and, thus, may be prescribed interchangeably.

No effect of itraconazole on the single oral dose pharmacokinetics and pharmacodynamics of estazolam. [2002.06]
To examine the involvement of cytochrome P450 3A4 in the metabolism of estazolam, the effect of itraconazole, a potent inhibitor of this enzyme, on the single oral dose pharmacokinetics and pharmacodynamics of estazolam was studied in a double-blind randomized crossover manner... The current study showed no significant effect of itraconazole on the single oral dose pharmacokinetics and pharmacodynamics of estazolam, suggesting that cytochrome P450 3A4 is not involved in the metabolism of estazolam to a major extent.

Gas chromatographic assay for estazolam in human plasma and results of a bioequivalence study. [1997.04]
This paper describes a new sensitive gas chromatographic method with electron capture detector to assay estazolam in human plasma, which has been developed and validated for pharmacokinetic purposes. The drug and the internal standard (triazolam) were extracted from plasma buffered at pH 9.0 into toluene and analysed on a widebore DB 17 column...

Effects of estazolam and flurazepam on cardiopulmonary function in patients with chronic obstructive pulmonary disease. [1992.03]
Benzodiazepine drugs have been shown to suppress respiratory function in patients with chronic obstructive pulmonary disease (COPD). We designed a placebo-controlled crossover study to compare the effects of a new benzodiazepine, estazolam ('ProSom'), with those of flurazepam ('Dalmane') on cardiopulmonary function in COPD patients...

more studies >>

Clinical Trials Related to Prosom (Estazolam)

Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients. [Completed]
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam

A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients [Completed]
The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.

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.

more trials >>


Page last updated: 2016-08-22

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