Ambien

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

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

Ambien Warnings

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

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