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).
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NEWS HIGHLIGHTSMedia Articles Related to Prosom (Estazolam)
Stress, Bad Bedtime Habits Cause Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.07.27]
Title: Stress, Bad Bedtime Habits Cause Insomnia
Category: Health News
Created: 7/25/2009 7:00:00 AM
Last Editorial Review: 7/27/2009
Pills Plus Psychotherapy Can Beat Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.05.20]
Title: Pills Plus Psychotherapy Can Beat Insomnia
Category: Health News
Created: 5/20/2009 2:00:00 AM
Last Editorial Review: 5/20/2009
Insomnia
Source: MedicineNet Biorhythms Specialty [2009.03.03]
Title: Insomnia
Category: Diseases and Conditions
Created: 6/6/2005
Last Editorial Review: 3/3/2009
Insomnia Treatment: Sleep Aids and Stimulants
Source: MedicineNet Narcolepsy Specialty [2009.01.14]
Title: Insomnia Treatment: Sleep Aids and Stimulants
Category: Diseases and Conditions
Created: 9/24/1999 7:06:00 AM
Last Editorial Review: 1/14/2009
Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Source: MedicineNet temazepam Specialty [2008.06.05]
Title: Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Category: Doctor's Views
Created: 6/14/2005
Last Editorial Review: 6/5/2008
Published Studies Related to Prosom (Estazolam)
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...
Estazolam treatment of insomnia in generalized anxiety disorder: a placebo-controlled study. [1991.08]
Estazolam, a triazolobenzodiazepine with an intermediate elimination half-life, has been shown previously to be an effective and safe hypnotic in insomniacs without concomitant psychiatric illness. Our study of the efficacy of estazolam in patients with insomnia associated with generalized anxiety disorder began when 108 patients meeting criteria for generalized anxiety disorder (mean total score of Hamilton Rating Scale for Anxiety [HAM-A] = 22.0 +/- 3.1 [SD]) and insomnia were given single-blind placebo for 7 nights...
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 [Recruiting]
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.
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