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Zolpidem tartrate
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| Name Zolpidem tartrate
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Zolpidem is a prescription medication used for the short-term treatment of insomnia, as well as some brain disorders. It is a short-acting nonbenzodiazepine hypnotic that potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by binding to gamma-aminobutyric acid (GABAA) receptors at the same location as benzodiazepines It works quickly (usually within 15 minutes) and has a short half-life (2–3 hours).ts hypnotic effects are similar to those of the benzodiazepine class of drugs, but it is molecularly distinct from the classical benzodiazepine molecule and is classified as an imidazopyridine. Flumazenil, a benzodiazepine receptor antagonist, which is used for benzodiazepine overdose, can also reverse zolpidem's sedative/hypnotic and memory impairing effects.As an anticonvulsant and muscle relaxant, the beneficial effects start to emerge at 10 and 20 times the dose required for sedation, respectively.[8] For that reason, it has never been approved for either muscle relaxation or seizure prevention. Such drastically increased doses are more inclined to induce one or more negative side-effects, including hallucinations and/or amnesia.
Zolpidem tartrateis a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol.
zolpidem tartrateis indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
DOSAGE AND ADMINISTRATION
The doseshould be individualized.
Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 mg per day.
Special populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Ambien in both of these patient populations is 5 mg once daily immediately before bedtime
Use with CNS depressants
Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects
Administration
The effectbe slowed by ingestion with or immediately after a meal.
HOW TO USE
Take this medication by mouth, usually once nightly immediately before bedtime on an empty stomach, or as directed by your doctor. Do not take it with food because the effect of the medication will be delayed.
Dosage is based on your medical condition, age, and response to therapy. Do not take more than 10 milligrams per day.
Although unlikely, this drug can infrequently cause temporary memory loss. To avoid this effect, do not take a dose of this drug unless you have time for a full night's sleep that lasts at least 7-8 hours. For example, do not take zolpidem during an overnight plane flight of less than 8 hours. SIDE EFFECTS: Dizziness, lightheadedness, headache, upset stomach, diarrhea, and dry mouth may occur. To minimize the risk of falls, remember to get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.
Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. If you discover that you have experienced any of these events, tell your doctor immediately. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling (especially of the face, lips, tongue, or throat), severe dizziness, trouble breathing.
PRECAUTIONS
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, mental/mood problems (e.g., depression), personal or family history of regular use/abuse of drugs/alcohol/other substances, lung/breathing problems (e.g., chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).
This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.
STORAGE
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children.
PRECAUTIONS
Abnormal thinking and behavioral changes
A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. 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. Visual and auditory hallucinations have been reported as well as behavioral changes such as bizarre behavior, agitation and depersonalization. In controlled trials, <>
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Zolpidem is a prescription medication used for the short-term treatment of insomnia, as well as some brain disorders. It is a short-acting nonbenzodiazepine hypnotic that potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by binding to gamma-aminobutyric acid (GABAA) receptors at the same location as benzodiazepines.[1] It works quickly (usually within 15 minutes) and has a short half-life (2–3 hours). Trade names of zolpidem include Adormix, Ambien, Ambien CR, Edluar, Damixan, Hypnogen, Ivedal, Lioran, Nytamel, Sanval, Stilnoct, Stilnox, Stilnox CR, Sucedal, Zoldem, Zolnod and Zolpihexal.[2][3][4][5]
Its hypnotic effects are similar to those of the benzodiazepine class of drugs, but it is molecularly distinct from the classical benzodiazepine molecule and is classified as an imidazopyridine. Flumazenil, a benzodiazepine receptor antagonist, which is used for benzodiazepine overdose, can also reverse zolpidem's sedative/hypnotic and memory impairing effects.[6][7]
As an anticonvulsant and muscle relaxant, the beneficial effects start to emerge at 10 and 20 times the dose required for sedation, respectively.[8] For that reason, it has never been approved for either muscle relaxation or seizure prevention. Such drastically increased doses are more inclined to induce one or more negative side-effects, including hallucinations and/or amnesia.
The patent in the United States on zolpidem was held by the French pharmaceutical corporation Sanofi-Aventis.[9] On April 23, 2007 the U.S. FDA approved 13 generic versions of zolpidem tartrate. Zolpidem is available from several generic manufacturers in the UK, as a generic from Sandoz in South Africa, as well as from other manufacturers such as Ratiopharm (Germany).
Information About Zolpidem Tartrate, Sold As Ambien or Stilnoct
Are you taking, or considering taking, Zolpidem Tartrate (Ambien, Stilnoct) as a sleeping aid? This page provides information on the medication's benefits, side effects, and other properties. A separate page lists the latest clinical trials and research articles focusing on this medication.
Article Contents
* Type of Medication: Hypnotic
* Benefits of Zolpidem (Ambien) for Insomnia
* Side Effects of Zolpidem (Ambien)
o Common
o Less Common
* Zolpidem (Ambien) and Alcohol
* Stopping Zolpidem (Ambien): Discontinuation Effects or Withdrawal Symptoms
* Should You Buy Zolpidem (Ambien) Online?
* Information Sources and Disclaimer
Type of Medication: Hypnotic
Zolpidem, a non-benzodiazepine, is a Hypnotic (or sleeping tablet).
Variants of zolpidem tartrate include Ambien and Stilnoct.
Benefits of Zolpidem (Ambien) for Insomnia
Zolpidem is a hypnotic, prescribed for the short term treatment of insomnia, or difficulty in getting to sleep or staying asleep. Insomnia is itself not an illness, but it can cause distress and potentially worsen some mental disorders such as mania.
Side Effects of Zolpidem (Ambien)
Please note that the following side effects include only some of the most common and somewhat less common but do not include rarer side effects; the list is not exhaustive. Many people taking Zolpidem (Ambien, Stilnoct) experience none of these side effects. Please consult a physician about any unusual symptoms.
Common
Some of the more common side effects of Zolpidem (Ambien, Stilnoct) include:
* drowsiness
* dizziness
* lightheadedness
* difficulty with coordination
* diarrhoea
* nausea
* vomiting
* vertigo
* headache
* asthenia
Less Common
Some of the less common side effects of Zolpidem (Ambien, Stilnoct) include:
* amnesia
* tolerance
* dependence
* changes in behaviour and thinking
Zolpidem (Ambien) and Alcohol
The manufacturer recommends that alcohol never be consumed while under treatment with Zolpidem or other sleeping tablets. Alcohol can significantly increase the side effects of Zolpidem or any other sleep medication.
Stopping Zolpidem (Ambien): Discontinuation Effects or Withdrawal Symptoms
It is best to consult a physician before discontinuing hypnotics. These medications can cause withdrawal symptoms even after only being used for a week or two, including unpleasant feelings. Other withdrawal symptoms, while very uncommon, include:
* abdominal and muscle cramps
* vomiting
* sweating
* shaking
* seizures
In addition, discontinuing sleep medications may cause 'rebound insomnia'. This means that a person may have more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. Rebound insomnia usually goes away on its own after 1 or 2 nights.
Should You Buy Zolpidem (Ambien) Online?
Particularly in the United States, many individuals choose to purchase medications online, either for reasons of cost savings, privacy, or both. Both brand-name Ambien and so-called 'generic Ambien' (i.e., Zolpidem Tartrate without the Ambien brand name) can sometimes be purchased at deep discounts (and sometimes without a prescription) in this way. Before undertaking any purchase of medications online, however -- and certainly if you are contemplating doing so without a prior prescription -- please consider the integrity of the supplier and the national and/or local laws which may apply where you live.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use zolpidem tartrate safely and effectively. See full prescribing information for zolpidem tartrate. zolpidem tartrate (zolpidem tartrate) tablet, film coated for oral use - CIV
Initial U.S. Approval: 1992
RECENT MAJOR CHANGES
Indications and Usage (1), 03/2007
Warnings and Precautions (5), 03/2007
INDICATIONS AND USAGE
Zolpidem Tartrate Tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1)
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use zolpidem tartrate safely and effectively. See full prescribing information for zolpidem tartrate. zolpidem tartrate (zolpidem tartrate) tablet, film coated for oral use - CIV
Initial U.S. Approval: 1992
RECENT MAJOR CHANGES
Indications and Usage (1), 03/2007
Warnings and Precautions (5), 03/2007
INDICATIONS AND USAGE
Zolpidem Tartrate Tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1)
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Zolpidem Tartrate Tablets, 5 mg are round, biconvex, pink, film coated tablets debossed with product identification "54 371" on one side and plain on the other and supplied as:
NDC NumberSize
0054-0086-25 bottle of 100
0054-0086-20 carton of 100 unit dose
0054-0086-29 bottle of 500
Zolpidem Tartrate Tablets, 10 mg are round, biconvex, white, film coated tablets debossed with product identification "54 553" on one side and plain on the other and supplied as:
NDC NumberSize
0054-0087-25 bottle of 100
0054-0087-20 carton of 100 unit dose
0054-0087-29 bottle of 500
16.2 Storage and Handling
Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature.]
17. PATIENT COUNSELING INFORMATION
17.1 General
Patient information is printed at the end of this insert. To assure safe and effective use of zolpidem tartrate tablets, this information and instructions provided in the patient information section should be discussed with patients.
17.2 FDA-Approved Patient Labeling
Your doctor has prescribed zolpidem tartrate tablets to help you sleep. The following information is intended to guide you in the safe use of this medicine. It is not meant to take the place of your doctor’s instructions. If you have any questions about zolpidem tartrate tablets be sure to ask your doctor or pharmacist.
Zolpidem tartrate tablets are used to treat different types of sleep problems in adults, such as:
• trouble falling asleep
• waking up too early in the morning
• waking up often during the night
Some people may have more than one of these problems.
Zolpidem tartrate tablets belong to a group of medicines known as the “sedative/hypnotics,” or simply, sleep medicines. 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 with your doctor about the risks and benefits of prolonged use.
SIDE EFFECTS
Most Common Side Effects
All medicines have side effects. Most common side effects of sleep medicines include:
• drowsiness
• dizziness
• lightheadedness
• difficulty with coordination
You may find that these medicines make you sleepy during the day. How drowsy you feel depends upon how your body reacts to the medicine, which sleep medicine you are taking, and how large a dose your doctor has prescribed. Daytime drowsiness is best avoided by taking the lowest dose possible that will still help you sleep at night. Your doctor will work with you to find the dose of zolpidem tartrate tablets that is best for you.
To manage these side effects while you are taking this medicine:
• When you first start taking zolpidem tartrate tablets or any other sleep medicine until you know whether the medicine will still have some carryover effect in you the next day, use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft.
• NEVER drink alcohol while you are being treated with zolpidem tartrate tablets or any sleep medicine. Alcohol can increase the side effects of zolpidem tartrate tablets or any other sleep medicine.
• Do not take any other medicines without asking your doctor first. This includes medicines you can buy without a prescription. Some medicines can cause drowsiness and are best avoided while taking zolpidem tartrate tablets.
• Always take the exact dose of zolpidem tartrate tablets prescribed by your doctor. Never change your dose without talking to your doctor first.
SPECIAL CONCERNS
There are some special problems that may occur while taking sleep medicines.
“Sleep-Driving” and Other Complex Behaviors
There have been reports of people getting out of bed after taking a sleep medicine and driving their cars while not fully awake, often with no memory of the event. If you experience such an event, it should be reported to your doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when zolpidem tartrate tablets are taken with alcohol or other drugs such as those for the treatment of depression or anxiety. Other behaviors such as preparing and eating food, making phone calls, or having sex have been reported in people who are not fully awake after taking a sleep medicine. As with “sleep-driving”, people usually do not remember these events.
Memory Problems
Sleep medicines may cause a special type of memory loss or “amnesia.” When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine.
Memory loss can be a problem, however, when sleep medicines are taken while traveling, such as during an airplane flight and the person wakes up before the effect of the medicine is gone. This has been called “traveler’s amnesia.”
Memory problems are not common while taking zolpidem tartrate tablets. In most instances memory problems can be avoided if you take zolpidem tartrate tablets only when you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.
Tolerance
When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as “tolerance.’’ Sleep medicines should, in most cases, be used only for short periods of time, such as 1 or 2 days and generally no longer than 1 or 2 weeks. If your sleep problems continue, consult your doctor, who will determine whether other measures are needed to overcome your sleep problems.
Dependence
Sleep medicines can cause dependence, especially when these medicines are used regularly for longer than a few weeks or at high doses. Some people develop a need to continue taking their medicines. This is known as dependence or “addiction.”
When people develop dependence, they may have difficulty stopping the sleep medicine. If the medicine is suddenly stopped, the body is not able to function normally and unpleasant symptoms (see Withdrawal) may occur. They may find they have to keep taking the medicine either at the prescribed dose or at increasing doses just to avoid withdrawal symptoms.
All people taking sleep medicines have some risk of becoming dependent on the medicine. However, people who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming addicted to sleep medicines. This possibility must be considered before using these medicines for more than a few weeks.
If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting zolpidem or any sleep medicine.
Withdrawal
Withdrawal symptoms may occur when sleep medicines are stopped suddenly after being used daily for a long time. In some cases, these symptoms can occur even if the medicine has been used for only a week or two.
In mild cases, withdrawal symptoms may include unpleasant feelings. In more severe cases, abdominal and muscle cramps, vomiting, sweating, shakiness, and rarely, seizures may occur. These more severe withdrawal symptoms are very uncommon.
Another problem that may occur when sleep medicines are stopped is known as “rebound insomnia.” This means that a person may have more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. If you should experience rebound insomnia, do not get discouraged. This problem usually goes away on its own after 1 or 2 nights.
If you have been taking zolpidem tartrate tablets or any other sleep medicine for more than 1 or 2 weeks, do not stop taking it on your own. Always follow your doctor’s directions.
Changes in Behavior and Thinking
Some people using sleep medicines have experienced unusual changes in their thinking and/or behavior. These effects are not common. However, they have included:
• more outgoing or aggressive behavior than normal
• loss of personal identity
• confusion
• strange behavior
• agitation
• hallucinations
• worsening of depression
• suicidal thoughts
How often these effects occur depends on several factors, such as a person’s general health, the use of other medicines, and which sleep medicine is being used. Clinical experience with zolpidem tartrate tablets suggests that it is uncommonly associated with these behavior changes.
It is also important to realize that it is rarely clear whether these behavior changes are caused by the medicine, an illness, or occur on their own. In fact, sleep problems that do not improve may be due to illnesses that were present before the medicine was used. If you or your family notice any changes in your behavior, or if you have any unusual or disturbing thoughts, call your doctor immediately.
Pregnancy
Sleep medicines 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 zolpidem.
Children
Zolpidem tartrate tablets have not been shown to help children fall asleep. Hallucinations, headache and dizziness have all been reported as side effects in children who were given zolpidem tartrate tablets.
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.
Zolpidem tartrate 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, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
