Table Of Contents
- Ambien Price Comparison Table
- Ambien Information
- Ambien Ingredients and Composition
- How Does Ambien Work?
- How To Take Ambien and Ambien Dosage and Administration
- If you suspect a Ambien Overdose
- Ambien Side Effects
- Ambien Warnings
- Taking Ambien during Pregnancy or Breast-feeding
- Ambien and Alcohol Interaction
- Ambien Drug Interactions
- Ambien Clinical Trials and Studies
- Storing Ambien
- Additional Patient Information for Ambien
- Information about the Manufacturer of Ambien
- Ambien Lawsuit and Litigation
- Credits for Ambien Information
Brand names: Ambien
Ambien Price Comparison Table
| Product | Qty | Price | Medical Fees & Shipping | Price/ Qty | Click to Order |
|---|---|---|---|---|---|
| View all available Ambien dosages | |||||
| Ambien 10mg | 30 | $139.00 | $18.00 | $4.63 | Buy from Billing-md |
| Ambien 10mg | 30 | $189.00 | $18.00 | $6.30 | Buy from IntegraRx |
| Ambien 10mg | 60 | $231.00 | $18.00 | $3.85 | Buy from Billing-md |
| Ambien 10mg | 60 | $269.00 | $18.00 | $4.48 | Buy from IntegraRx |
| Ambien 10mg | 90 | $369.00 | $18.00 | $4.10 | Buy from IntegraRx |
| Ambien 10mg | 90 | $379.00 | $18.00 | $4.21 | Buy from Billing-md |
Ambien 10mg 
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Ambien Information
Generic Name: Zolpidem Tartrate
Ambien (zolpidem tartrate) is used to treat different types of sleep problems, such as:
- trouble falling asleep
- waking up too early in the morning
- waking up often in the night
- some people may have more than one of these problems
Ambien belongs to a group of medicines known as the "sedative/hypnotics," or simply, sleep medicines.
Indications:
Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia. 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 (zolpidem tartrate) should not be prescribed in quantities exceeding a 1-month supply.
Ambien (zolpidem tartrate) has been shown to decrease sleep latency and increase the duration of sleep for up to 5 weeks in controlled clinical studies.
Ambien Ingredients and Composition
Zolpidem tartrate, the active ingredient in Ambien, is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.
Chemically, zolpidem is N,N,6-trimethyl-2-p-toyl-imidazo(1,2,-a)pyridine-3-acetamide L-(+)-tartrate (2:1).
Zolpidem tartrate, the active ingredient in Ambien, is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.
Each Ambien tablet includes the following inactive ingredients:
- hydroxypropyl methylcellulose
- lactose
- magnesium stearate
- microcrystalline cellulose
- polyethylene glycol
- sodium starch glycolate
- titanium dioxide
- the 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
How Does Ambien Work?
Subunit modulation of the GABAa receptor chloride channel macromolecular complex is hypothesized to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant Ambien properties. The major modulatory site of the GABAa receptor complex is located on its alpha (a) subunit and is referred to as the benzodiazepine (BZ) or receptor. At least three subtypes of the receptor have been identified.
While zolpidem, the active ingredient in Ambien, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all three omega receptor subtypes, zolpidem in vitro binds the (w1) receptor preferentially. The(w1) receptor is found primarily on the Lamina IV of the sensorimotor cortical regions, substantia nigra (pars reticulata), cerebellum molecular layer, olfactory bulb, ventral thalamic complex, pons, inferior colliculus, and globus pallidus. This selective binding of zolpidem on the (w1) receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses.
How To Take Ambien and Ambien Dosage and Administration
The Ambien dose should be individualized.
The recommended Ambien dose for adults is 10 mg immediately before bedtime.
Downward Ambien dosage adjustment may be necessary when it is administered with agents having known CNS-depressant effects because of the potentially additive effects.
Elderly or debilitated patients may be especially sensitive to the effects of Ambien (zolpidem tartrate). Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients.
The total Ambien (zolpidem tartrate) dose should not exceed 10 mg.
If you suspect a Ambien Overdose
Signs and Symptoms
In European postmarketing reports of overdose with zolpidem alone, impairment of consciousness has ranged from somnolence to light coma. There was one case each of cardiovascular and respiratory compromise. Individuals have fully recovered from Ambien overdoses up to 400 mg (40 times the maximum recommended dose). Overdose cases involving multiple CNS-depressant agents, including zolpidem, have resulted in more severe symptomatology, including fatal outcomes.
Recommended Treatment
General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Flumazenil may be useful. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following Ambien overdosage, even if excitation occurs. The value of dialysis in the treatment of Ambien overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable.
Poison Control Center
As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up- to-date information on the management of hypnotic drug product overdosage.
Ambien Side Effects
The following Ambien side effects are the most common:
Central and Peripheral Nervous System
- Headache
- Drowsiness
- Dizziness
Gastrointestinal System
- Nausea
- Diarrhea
Musculoskeletal System
- Myalgia
Associated With Discontinuation Of Treatment
Approximately 4% of 1,701 patients who received Ambien at all doses (1.25 to 90 mg) in U.S. pre-marketing clinical trial discontinued treatment because of an adverse clinical event. Side effects most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).
Approximately 6% of 1320 patients who received Ambien at all doses (5 to 50 mg) in similar European trials discontinued treatment because of a side effects. Events most commonly associated with discontinuation from these trials were daytime drowsiness (1.6%), amnesia (0.6%), dizziness (0.6%), headache (0.6%), nausea (0.6%).
There may be additional unreported Ambien side effects.
Ambien Warnings
Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic Ambien treatment of the insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness which should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including Ambien. Because some of the important adverse effects of ambien appear to be dose related, it is important to use the smallest possible effective dose, especially in the elderly.
A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics such as Ambien. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking, has been reported in association with the use of sedative/hypnotics.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above are drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Following the rapid dose decrease or abrupt discontinuation of sedative/hypnotics such as Ambien, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs.
Ambien, like other sedative/hypnotic drugs, has CNS-depressant effects. Due to the rapid onset of action, Ambien should only be ingested immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of zolpidem tartrate. Ambien showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when Ambien is administered with such agents because of the potentially additive effects.
Taking Ambien during Pregnancy or Breast-feeding
Sleep medicines such as Ambien may cause sedation of the unborn baby when used during the last weeks of pregnancy.
Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking Ambien (zolpidem tartrate).
Ambien and Alcohol Interaction
Never drink alcohol while you are being treated with zolpidem tartrate or any sleep medicine. Alcohol can increase the side effects of zolpidem tartrate or any other sleep medicine.
Ambien Drug Interactions
CNS-Active Drugs
Ambien (zolpidem tartrate) was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. The lack of a drug interaction following single-dose Ambien administration does not predict a lack following chronic administration.
An additive effect on psychomotor performance between alcohol and Ambien was demonstrated.
Since the systemic evaluation of Ambien (zolpidem tartrate) in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with zolpidem. Any drug with CNS-depressant effects could potentially enhance the CNS- depressant effects of zolpidem.
Other Drugs
A study involving cimetidine/zolpidem and ranitidine/zolpidem combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem. Ambien (Zolpidem) had no effect on digoxin kinetics and did not effect prothrombin time when given with warfarin in normal subjects. Zolpidem's sedative/hypnotic effect was reversed by flumazenil; however, no significant alterations in zolpidem pharmacokinetics were found.
Ambien Clinical Trials and Studies
Controlled Trials Supporting Ambien Safety And Efficacy
Transient Insomnia
Normal adults experiencing transient insomnia (n=462) during the first night in a sleep laboratory were evaluated in a double blind, parallel group, single-night trial comparing two doses of Ambien (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings.
Chronic Insomnia
Adult outpatients, with chronic insomnia (n=75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of Ambien (10 and 15 mg) and placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 15 mg was superior to placebo for all 5 weeks; Ambien 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Ambien was comparable to placebo on number of awakenings at both doses studied.
Adult outpatients (n=141) with chronic insomnia were evaluated in a double-blind, parallel group, 4-week trial comparing two doses of Ambien (zolpidem) (10 and 15 mg) and placebo. Ambien (Zolpidem) 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week. Ambien (Zolpidem) 15 mg was superior to placebo on a subjective measure of sleep latency for the first 3 weeks, on a subjective measure of total sleep time for the first week, and on number of awakenings and sleep quality for the first 2 weeks.
Next-day Residual Effects
There was no evidence of residual next-day effects seen with Ambien (zolpidem tartrate) in several studies utilizing the Multiple Sleep latency Test (MSLT), the Digit Symbol Substitution Test (DSST), and patient ratings of alertness. In one study involving elderly patients, there was a small but statistically significant decrease in one measure of performance, the DSST, but no impairment was seen in the MSLT study.
Rebound Effects
There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Ambien. There was subjective evidence of impaired sleep in the elderly on the first posttreatment night at doses above the recommended elderly dose of 5 mg.
Memory Impairment
Two small studies (n=6 and n=9) utilizing objective measures of memory yielded little evidence for memory impairment following the administration of Ambien (zolpidem tartrate). There was subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration Ambien (zolpidem tartrate), predominantly at doses above 10 mg.
Effects on sleep stages
In studies that measured the percentage of sleep time spent in each sleep stage, Ambien (zolpidem tartrate) has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.
Storing Ambien
Store Ambien below 86°F (30°C).
Additional Patient Information for Ambien
There are many different sleep medicines available to help people sleep better. Sleep problems are usually temporary, requiring treatment for only a short time, usually 1 or 2 days up to 1 or 2 weeks. Some people have chronic sleep problems that may require more prolonged use of sleep medicine. However, you should not use these medicines for long periods without talking to your doctor about the risks and benefits of prolonged use.
Information about the Manufacturer of Ambien
Ambien is produced by:
Searle
Ambien Lawsuit and Litigation
Claims have been made that Searle, the manufacturer of Ambien, has not taken due care to researching and/or providing side effects and drug interaction information, leading to serious adverse effects, and even deaths.
An example of this is a drug product liability case initiated against Searle Chemicals a/k/a G.D. Searle, by an individual in the US. His wife had first been prescribed Biaxin, an antibiotic, followed by Ambien for the treatment of the insomnia which was presumably a side effect of the said antibiotic. No information on the potential drug interaction was provided. Several days later she commited suicide by hanging herself.
The only side effects information that was provided for Ambien had been that it may cause 'daytime drowsiness or dizziness'.
Interestingly, file documentation indicates that prior to March of 2000, Searle had knowledge of seventeen suicides, fifteen suicide attempts and six "non-accidental overdoses" involving Ambien, Stilnox and/or zolpidem in which they were primarily suspect.
In the drug product liability counts of his complaint, the plaintiff, among other things, that Searle failed to adequately research and test Ambien and didn't provide adequate information as to its interaction with other drugs (apparently with Biaxin in this case), and also failed to adequately warn of contraindications for certain persons to whom it may be prescribed in that it could induce depressive, irrational and suicidal behavior.
While the case is still pending at the time of the writing of this article, it is clear that it is not an isolated occurance and that more Ambien litigation can be expected, especially with the issue of Searle publishing Ambien propaganda not in line with FDA regulations.
Create link from 'Ambien Propaganda' to the FDA warning letter. and also add 'FDA Warning Letter' to related articles at the bottom of the page...
Credits for Ambien Information
Ambien information on this page is copyright by Drug Information at Pharma-Help.com, reprinted with Permission. All Rights Reserved. Other pages with reprint permission include Ambien.