NEWS HIGHLIGHTSMedia Articles Related to Edluar (Zolpidem)
Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo(R) New Drug Application
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.10.30]
Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
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
Published Studies Related to Edluar (Zolpidem)
Effects on sleep stages and microarchitecture of caffeine and its combination with zolpidem or trazodone in healthy volunteers. [2009.07]
Caffeine is the world's most popular stimulant and is known to disrupt sleep... These data suggest that caffeine mimics some, but not all of the sleep disruption seen in insomnia and that its disruptive effects are differentially attenuated by the actions of sleep-promoting compounds with distinct mechanisms of action.
Zolpidem extended-release improves sleep and next-day symptoms in comorbid insomnia and generalized anxiety disorder. [2009.06]
A multicenter, double-blind, parallel-group study was designed to assess the efficacy and safety of zolpidem extended-release coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Patients (N = 383) received open-label escitalopram 10 mg/d and were randomized to either adjunct zolpidem extended-release 12.5 mg or placebo...
Short-term clarithromycin administration impairs clearance and enhances pharmacodynamic effects of trazodone but not of zolpidem. [2009.06]
The kinetic and dynamic interactions of 5 mg zolpidem and 50 mg trazodone with 500 mg clarithromycin (4 doses given over 32 h) were investigated in a 5-way double crossover study with 10 healthy volunteers. The five treatment conditions were: placebo + placebo; zolpidem + placebo; zolpidem + clarithromycin; trazodone + placebo; and trazodone + clarithromycin.
Sublingual zolpidem is more effective than oral zolpidem in initiating early onset of sleep in the post-nap model of transient insomnia: a polysomnographic study. [2009.06]
OBJECTIVE: OX22 is zolpidem formulated for sublingual administration. The primary objective of the present study was to evaluate the efficacy of single doses of sublingual zolpidem (5 and 10mg) versus oral zolpidem (10mg), with regard to latency to persistent sleep (LPS), in a post-nap model of insomnia... CONCLUSION: The present results show that OX22, a sublingual formulation of zolpidem, has a significant earlier sleep initiation as compared to an equivalent dose of oral zolpidem in healthy volunteers in a post-nap model of insomnia.
Incidence of clinically significant responses to zolpidem among patients with disorders of consciousness: a preliminary placebo controlled trial. [2009.05]
OBJECTIVES: The common hypnotic, zolpidem, has been reported to temporarily restore consciousness to individuals in the chronic vegetative state. In drug responders, repeated dosing appears to maintain consciousness. The frequency of such responses, however, is unknown and is important both to guide clinical use and to plan further research on the mechanisms underlying drug response. The objectives of this study were to obtain an estimate of the frequency of clinically significant responses among individuals with disorders of consciousness, to determine whether less obvious drug responses are present among "nonresponders," and to identify clinical features characteristic of zolpidem responders... CONCLUSION: These results confirm that clinically significant responses to zolpidem among individuals with disorders of consciousness do occur in a minority of patients and can be replicated. Failure to find a trend toward improved performance on zolpidem among nonresponders suggests a bimodal rather than a graded response to the drug. The fact that only one drug responder was identified in this small study prevents assessment of features characteristic of drug responders.
Clinical Trials Related to Edluar (Zolpidem)
Zolpidem CR and Hospitalized Patients With Dementia [Recruiting]
The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of
placebo in improving sleep efficiency in people with dementia admitted to the hospital
because of their symptoms. You can participate in this study if you have dementia of the
Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet
that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We
will use placebos to see if the study results are due to the study drug or due to other
reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription.
Zolpidem CR is approved by the U. S. Food and Drug Administration (FDA) for the short-term
treatment of insomnia (trouble falling or staying asleep).
Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem [Not yet recruiting]
This study will compare the interactions of a placebo and two FDA-approved sleeping
medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in
the brain. We want to show that we can use positron emission tomography images to measure
the binding of these medications to the receptors.
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.
Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women [Recruiting]
This study has been designed to compare the effects of melatonin with those of drugs
(temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy,
middle-aged volunteers.
The study will take place at one centre. Volunteers consenting to participate in the study
will have their eligibility confirmed by a screening panel, including spending one night in
the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be
collected during this overnight visit.
Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam,
zolpidem and placebo as a single dose during 4 treatment phases lasting one night and
separated by at least five days. Neither the volunteer nor the study staff will be aware of
which drug each volunteer is receiving at each treatment phase.
The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects
of sleep, including measures of sleep quality, will also be measured. Urine samples will be
collected during each treatment phase.
Volunteers will undergo an assessment of health prior to departure from the clinic at their
last treatment phase, and study staff will telephone 2 weeks later to obtain further
information on their health status.
The primary study objective is to compare EEG power spectra during nonREM sleep in the
slow-wave frequencies following administration with melatonin to temazepam.
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography [Recruiting]
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
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