AMBIEN SUMMARY
Ambien® CIV
(zolpidem tartrate)
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).
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AMBIEN NEWS HIGHLIGHTS Media Articles Related to Ambien (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.
American Lung Association Calls For Tighter Nitrogen Dioxide Air Pollution Standard
Source: Respiratory / Asthma News From Medical News Today [2009.06.29]
The American Lung Association calls on the U.S. Environmental Protection Agency (EPA) to strengthen the national ambient air quality standards for nitrogen dioxide (NO2). EPA is expected to release its proposal to revise this public health standard that has remained unchanged since 1971. Changes to the national air quality standard for NO2 pollution will become the new official limit on this air pollutant that each county in the nation must meet.
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.
Published Studies Related to Ambien (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] 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] 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] 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] 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] 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 (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 PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 30 ratings/reviews, Ambien has an overall score of 7.30. The effectiveness score is 8 and the side effect score is 7.33. 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 33 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | restlessness |
| Dosage & duration: | | 50mg taken 1 /day for the period of 6 months |
| Other conditions: | | anxiety |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | allowed me to sleep soundly without feeling groggy in the morning. |
| Side effects: | | I didn't have any side effects if I was allowed enough sleep. If I did not receive enough sleep it would be very hard to wake up and I would feel as if I had not slept at all making it very hard to stay alert. I would say at least 6-7 hours of sleep is needed. |
| Comments: | | Take one daily at bedtime for rest due to anxiety. This prescription was issued for six months and I am currently still taking it. It does not appear to be addictive as there are nights when I can sleep without it and do not crave it. |
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| | 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. |
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| | Ambien review by 55 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | not sleeping |
| Dosage & duration: | | 10 mg taken 1 time per day for the period of 5 days |
| Other conditions: | | none |
| Other drugs taken: | | vitamins | | |
Reported Results |
| Benefits: | | there were no treatment benefits only bad side effects such as terrible nightmares, hyperventilating |
| Side effects: | | see above, terrible nightmares, hyperventilation upon waking from the nightmares |
| Comments: | | i was supposed to take the product every night in order to sleep. i stopped after 5 sleepless nights |
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Page last updated: 2009-06-30
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