NEWS HIGHLIGHTSMedia Articles Related to Ambien CR (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 Ambien CR (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 Ambien CR (Zolpidem)
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia. [Active, not recruiting]
The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate
(Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the
efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each
of these two medications with placebos.
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Under Fasting Conditions [Completed]
A Study to Assess Facilitation of the Discontinuation of Zolpidem by Ramelteon Administration in Subjects With Chronic Insomnia [Active, not recruiting]
This study is designed to assess whether administration of ramelteon will facilitate the
discontinuation of zolpidem in subjects with chronic insomnia. Subjects will receive placebo
or ramelteon, in addition to decreasing doses of zolpidem, over the course of the study. At
the end of the study, ramelteon will be compared with placebo with respect to the number of
subjects who no longer require zolpidem therapy.
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia [Completed]
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release)
12. 5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with
primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings
and patient sleep questionnaires.
The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR
12. 5 mg and zolpidem 10 mg marketed product in comparison with placebo.
Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Tablets [Completed]
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 10 ratings/reviews, Ambien CR has an overall score of 8.30. The effectiveness score is 9 and the side effect score is 8.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Ambien CR review by 33 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | insomnia |
| Dosage & duration: | | 10mg taken periodically for the period of 1 year |
| Other conditions: | | stress |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | much improved sleep without waking in the middle of the night. |
| Side effects: | | none really. Maybe groggy but not terribly. |
| Comments: | | Took 1 pill at bedtime |
|
| | Ambien CR review by 46 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | insomnia |
| Dosage & duration: | | 12.5 mg. taken daily for the period of 4 years |
| Other conditions: | | anxiety |
| Other drugs taken: | | seroquel | | |
Reported Results |
| Benefits: | | Immediate ability to fall asleep and stay asleep. No side effects in the morning. |
| Side effects: | | I have to take the drup on an empty stomach. Very bad side effects if taken with alcohol. Taken alone, side effects were increased night eating and loss of memory after taking the medication. If you do not go to sleep immediately you may drive or do things without using good sense. |
| Comments: | | Treatment is 12.5 miligrams for an indefinate period of time. |
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| | Ambien CR review by 36 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | insomnia |
| Dosage & duration: | | 12.5 mg per night taken every night for the period of 1 year + |
| Other conditions: | | depression, anxiety, headaches |
| Other drugs taken: | | wellbiutren, estridol, soma, darvecet, nortriptyline, meridian | | |
Reported Results |
| Benefits: | | I was able to turn my thoughts off at night |
| Side effects: | | memory loose, I am dependent on the drug and look forward to when I can take it. I not only experience memory loose @ the time of the dose but have also noticed were I cannot recall a week of activities. |
| Comments: | | a 12.5 mg pill a night |
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