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Ambien (Zolpidem Tartrate) - Summary

 
 



AMBIEN SUMMARY

Ambien (zolpidem tartrate), is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5-mg and 10-mg strength tablets for oral administration.

Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia. Ambien has been shown to decrease sleep latency and increase the duration of sleep for up to 35 days in controlled clinical studies ( Clinical Pharmacology: Controlled trials supporting safety and efficacy).

Hypnotics should generally be limited to 7 to 10 days of use, and reevaluation of the patient is recommended if they are to be taken for more than 2 to 3 weeks. Ambien should not be prescribed in quantities exceeding a 1-month supply (see Warnings).


See all Ambien indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ambien (Zolpidem)

FDA: Lower Ambien's Dose to Prevent Drowsy Driving
Source: MedicineNet zolpidem Specialty [2013.05.16]
Title: FDA: Lower Ambien's Dose to Prevent Drowsy Driving
Category: Health News
Created: 5/15/2013 12:36:00 PM
Last Editorial Review: 5/16/2013 12:00:00 AM

ER Visits Tied to Ambien on the Rise
Source: MedicineNet zolpidem Specialty [2013.05.01]
Title: ER Visits Tied to Ambien on the Rise
Category: Health News
Created: 5/1/2013 10:35:00 AM
Last Editorial Review: 5/1/2013 12:00:00 AM

Insomnia Drug Linked to Doubling of ED Visits
Source: Medscape Psychiatry & Mental Health Headlines [2014.08.15]
Overmedication with the insomnia drug zolpidem led to a near doubling of emergency department visits between 2006 and 2010 and is especially problematic for women.
Medscape Medical News

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

more news >>

Published Studies Related to Ambien (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 (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 (Zolpidem) Side Effects

Drug Ineffective (36)Insomnia (35)Somnambulism (26)Road Traffic Accident (23)Suicide Attempt (21)Pain (20)Completed Suicide (20)Intentional Overdose (17)Somnolence (17)Stress (17)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 34 ratings/reviews, Ambien has an overall score of 7.09. The effectiveness score is 7.88 and the side effect score is 7.35. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Ambien review by 45 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   10 mg taken one to two times a week for the period of ongoing
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Occasionally I have a difficult time falling asleep and sleeping through the night. When I take this medicine I fall asleep within 15 or so minutes and am able to sleep 7 or 8 hours. My sleep seems undisturbed and uneventful. When I wake up in the morning I awake completely alert and energized.
Side effects:   I did not experience any treatment side effects.
Comments:   I have been taking this medication for occasional insomnia for over one year now. I will continue to take this medication to treat my insomnia for as long as my physician prescribes it for me.

 

Ambien review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   inability to fall asleep easily
Dosage & duration:   5mg taken 2-3 times week for the period of 1 yr
Other conditions:   fibromyalgia
Other drugs taken:   wellbutrin
  
Reported Results
Benefits:   I have a background of worry and stress-related symptoms where I am unable to wind down at the end of the day. With this drug I am able to fall asleep within 30 minutes
Side effects:   Depending on how late I go to bed, and how early I get up in the morning, sometimes would wake up groggy. I would need at least 7-8 hours of sleep to not get groggy.
Comments:   1/2 of a 10 mg pill as needed. Purposely would take it sparingly due to any addictive issues. Some doctors believe it is truly addictive; others not so. But I believe in as few drugs as possible in my life. I am also very afraid of any type of addiction. Therefore, I opt to split the pill in half and only take it 2-3 times a week.

 

Ambien review by 28 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   10mg taken 1 pill for the period of 1 before bedtime
Other conditions:   depression anxeity
Other drugs taken:   none
  
Reported Results
Benefits:   none
Side effects:   none
Comments:   i went to my doctor because i was getting only 4 hours of sleep a night for the past 6 days, so he gives me one pill, yes that's right just one 10mg pill. anyways i took it at 10pm and its now 4:30 in the morning and i still cant sleep which is why im here to review this. and i have to been into work by 6am aaaaarrrgh!

See all Ambien reviews / ratings >>

Page last updated: 2014-08-15

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