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Ambien CR (Zolpidem Tartrate) - Summary

 
 



AMBIEN CR SUMMARY

Ambien CR™    CIV
(zolpidem tartrate extended-release tablets)

Ambien CR contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class.

Ambien CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). (See Clinical Pharmacology: Controlled trials supporting safety and efficacy.)

The clinical trials performed in support of efficacy were both 3 weeks in duration, although the final formal assessments of sleep latency and maintenance were performed after 2 weeks of treatment.


See all Ambien CR indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ambien CR (Zolpidem)

Belsomra Approved for Insomnia
Source: MedicineNet Sleep Specialty [2014.08.15]
Title: Belsomra Approved for Insomnia
Category: Health News
Created: 8/14/2014 12:35:00 PM
Last Editorial Review: 8/15/2014 12:00:00 AM

FDA Approves New Kind of Insomnia Drug
Source: MedicineNet Clinical Trials Specialty [2014.08.14]
Title: FDA Approves New Kind of Insomnia Drug
Category: Health News
Created: 8/13/2014 7:36:00 PM
Last Editorial Review: 8/14/2014 12:00:00 AM

10 Tips to Avoid Insomnia and Get a Good Night's Sleep
Source: MedicineNet Sleep Aids And Stimulants Specialty [2014.07.18]
Title: 10 Tips to Avoid Insomnia and Get a Good Night's Sleep
Category: Doctor's Views
Created: 6/14/2005 12:00:00 AM
Last Editorial Review: 7/18/2014 12:00:00 AM

Insomnia
Source: MedicineNet Biorhythms Specialty [2014.07.17]
Title: Insomnia
Category: Diseases and Conditions
Created: 6/6/2005 12:00:00 AM
Last Editorial Review: 7/17/2014 12:00:00 AM

Insomnia Treatment (Sleep Aids and Stimulants)
Source: MedicineNet Jet Lag Specialty [2014.07.17]
Title: Insomnia Treatment (Sleep Aids and Stimulants)
Category: Diseases and Conditions
Created: 9/24/1999 7:06:00 AM
Last Editorial Review: 7/17/2014 12:00:00 AM

more news >>

Published Studies Related to Ambien CR (Zolpidem)

Improved insomnia symptoms and sleep-related next-day functioning in patients with comorbid major depressive disorder and insomnia following concomitant zolpidem extended-release 12.5 mg and escitalopram treatment: a randomized controlled trial. [2011.07]
CONCLUSIONS: Zolpidem extended-release administered concomitantly with escitalopram for up to 24 weeks was well tolerated and improved insomnia and some sleep-related next-day symptoms and next-day functioning in patients with MDD but did not significantly augment the antidepressant response of escitalopram. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00296179. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

The use of a non-benzodiazepine hypnotic sleep-aid (Zolpidem) in patients undergoing ACL reconstruction: a randomized controlled clinical trial. [2011.05]
PURPOSE: Previous studies have addressed post-operative pain management after ACL reconstruction by examining the use of intra-articular analgesia and/or modification of anesthesia techniques. To our knowledge, however, no previous studies have evaluated the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. The purpose of this prospective, blinded, randomized, controlled clinical study was to evaluate the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction... CONCLUSION: Adding zolpidem to the post-operative medication regimen after arthroscopic ACL reconstruction helps to lower the amount of narcotic pain medication required for adequate analgesia. LEVEL OF EVIDENCE: Randomized controlled clinical trial, Level I.

Zolpidem and zopiclone impair similarly monotonous driving performance after a single nighttime intake in aged subjects. [2011.04]
RATIONALE: Although hypnotics are primarily used by older people, the residual effects the morning after a single nighttime intake of the two most commonly prescribed hypnotics, zolpidem (Zp) and zopiclone (Zc), on older middle-aged drivers have not been evaluated and compared... CONCLUSIONS: This is the first study revealing residual effects of Zp on driving performance in ageing drivers which are similar to that of Zc. Studying the effects of medication in different age ranges appears useful to complete the studies on behavioural-pharmacological effects of medication. To reduce the incidence of driving accidents due to prescription drugs, patients should be warned at the time of treatment initiation that they should avoid driving.

Twelve months of nightly zolpidem does not lead to dose escalation: a prospective placebo-controlled study. [2011.02.01]
STUDY OBJECTIVES: To assess hypnotic self-administration and likelihood of dose escalation over 12 months of nightly use of zolpidem versus placebo in primary insomniacs... CONCLUSIONS: Zolpidem was preferred to placebo, but its self-administration did not increase with 12 months of use. Chronic hypnotic use by primary insomniacs does not lead to dose escalation.

A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomnia. [2011.01]
BACKGROUND: Benzodiazepines cause a high proportion of adverse effects while non-benzodiazepine compounds have demonstrated high efficacy and less adverse effects in patients with insomnia. The objective of this study was to compare the effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia... CONCLUSION: There was no significant difference between zaleplon and zolpidem in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either zolpidem or zaleplon is free from next-day residual effects.

more studies >>

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.

A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients [Recruiting]
The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.

Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Under Fasting Conditions [Completed]

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).

Use of Zolpidem in Parkinson's Disease [Not yet recruiting]
Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism.

The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.

more trials >>

Reports of Suspected Ambien CR (Zolpidem) Side Effects

Drug Ineffective (10)Somnambulism (9)Road Traffic Accident (8)Drug Abuse (6)Abnormal Behaviour (6)Amnesia (6)Intentional Overdose (5)Product Quality Issue (5)Prostate Cancer (5)Headache (4)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 17 ratings/reviews, Ambien CR has an overall score of 7.35. The effectiveness score is 8 and the side effect score is 7.53. 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.

 

Ambien CR review by 30 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   6.5 (dosage frequency: 1 per night) for the period of 2 nights
Other conditions:   none known
Other drugs taken:   aciphex
  
Reported Results
Benefits:   None. It didn't help me sleep. I was cranky the next day, depressed, and tired.
Side effects:   I took it for 2 days. The third day I didn't take it. Which was tonight. I keep waking up because my subconsious is terrified of something. I keep hearing things in my sleep. I am terrified to go back to sleep. My heart is pounding from the horrible things I keep hearing in my sleep. I never had this until taking this medication. I think I may miss a day of work tomorrow from not being able to sleep. I wish someone was here with me so I wouldn't be so afraid to go back to sleep but the sounds I keep hearing are so terrifying.
Comments:   My doctor gave me some samples for insomnia.

See all Ambien CR reviews / ratings >>

Page last updated: 2014-08-15

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