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.
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AMBIEN CR NEWS HIGHLIGHTS Media Articles Related to Ambien CR (Zolpidem)
'Awakenings' That Occur With Popular Sleep-Aid Ambien May Be Explained By GUMC Study
Source: Biology / Biochemistry News From Medical News Today [2009.06.30]
Some people who take the fast-acting sleep-aid zolpidem (Ambien) have been observed walking, eating, talking on the phone and even driving while not fully awake. Many often don't remember doing any of these activities the next morning. Similarly, this drug has been shown to awaken the minimally conscious into a conscious state. A new study by Georgetown University Medical Center (GUMC) researchers may help explain why these "awakenings" occur.
Transcept Pharmaceuticals Announces Expected FDA Extension Of Regulatory Review Period For Intermezzo(R)
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.13]
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009.
Scientists Search For Sleepless Souls Suffering Lifelong Insomnia, Scotland
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.21]
Most people have experienced the odd sleepless night before a crucial exam, a job interview or before going on holiday, but few people get by with just a couple of hours of sleep a day, every day. Terry McKinnes, 54, of Falkirk, is one of the unfortunate people who suffers from idiopathic insomnia who feels she has spent almost her entire life awake.
APSS: Nonsedating Sleep Aid Improves Insomnia and Performance (CME/CE)
Source: MedPage Today Psychiatry [2009.06.18]
SEATTLE (MedPage Today) -- An investigational nonsedating medication improved sleep maintenance without residual next-day effects in a placebo-controlled trial of patients with chronic insomnia.
Frontal Cerebral Hypothermia Found To Be Possible New Treatment For Insomnia
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.14]
Insomnia is associated with increased frontal cerebral metabolism during Rapid Eye Movement (REM) sleep. Cerebral hypothermia, or cooling of the brain, has been found to reduce cerebral metabolism in other medical conditions, but its effects in insomnia are unknown. In a University of Pittsburgh study by Eric Nofzinger, M.D.
Published Studies Related to Ambien CR (Zolpidem)
Zolpidem extended-release 12.5 mg associated with improvements in work performance in a 6-month randomized, placebo-controlled trial. [2008.10.01]
BACKGROUND: Although most research on pharmacotherapy for chronic insomnia focuses on changes in sleep outcomes, the functional impact of treatment is also of great importance to patients, families, physicians, and employers. OBJECTIVE: To analyze changes in functioning at work (or work performance) among a subset of employed subjects (N = 752) from a 24-week, randomized, double-blind, placebo-controlled trial of zolpidem [generic for Ambien CR] extended-release 12.5 mg taken nightly, at least 3 nights per week, by healthy adults with chronic insomnia... CONCLUSIONS: Employed adults with chronic insomnia treated with zolpidem extended-release 12.5 mg experienced significantly improved work performance over 24 weeks.
Hypnotherapy in the treatment of chronic combat-related PTSD patients suffering from insomnia: a randomized, zolpidem-controlled clinical trial. [2008.07]
This study evaluated the benefits of add-on hypnotherapy in patients with chronic PTSD. Thirty-two PTSD patients treated by SSRI antidepressants and supportive psychotherapy were randomized to 2 groups: 15 patients in the first group received Zolpidem [generic for Ambien CR] 10 mg nightly for 14 nights, and 17 patients in the hypnotherapy group were treated by symptom-oriented hypnotherapy, twice-a-week 1.5-hour sessions for 2 weeks...
A polysomnographic placebo-controlled evaluation of the efficacy and safety of eszopiclone relative to placebo and zolpidem in the treatment of primary insomnia. [2008.06.15]
STUDY OBJECTIVES: To evaluate the polysomnographic efficacy and the safety of a range of doses of eszopiclone relative to placebo in patients with primary insomnia. Zolpidem [generic for Ambien CR] 10 mg was included as an active control... CONCLUSIONS: Relative to placebo, all active treatments were effective in reducing LPS and increasing SE. Eszopiclone 3 mg was significantly different from placebo on the 3 PSG measures of sleep maintenance (WASO, WTDS, and NAW). Significant differences between zolpidem 10 mg and eszopiclone (2 mg or 3 mg) were not observed for PSG-measured outcomes, although the study was not powered to detect differences between the active drug conditions.
Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. [2008.01.01]
STUDY OBJECTIVES: To evaluate long-term efficacy and safety of zolpidem [generic for Ambien CR] extended-release 3 to 7 nights/week for chronic primary insomnia... CONCLUSIONS: These findings establish the efficacy of 3 to 7 nights per week dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness.
Efficacy and Safety of Zolpidem Extended Release in Elderly Primary Insomnia Patients. [2008.01]
Objectives: To evaluate the clinical efficacy and safety of zolpidem [generic for Ambien CR] extended release for the treatment of primary insomnia in elderly patients. Methods: A randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted... Conclusions: Zolpidem extended release 6.25 mg improved both sleep maintenance and sleep induction in elderly primary insomnia patients during three weeks of administration.
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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AMBIEN CR PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 7 ratings/reviews, Ambien CR has an overall score of 8.43. The effectiveness score is 9.43 and the side effect score is 7.71. 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 |
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| | 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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Page last updated: 2009-06-30
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