Zolpidem Tartrate (Page 5 of 5)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, mutagenesis, impairment of fertility

Carcinogenesis: Zolpidem was administered to rats and mice for 2 years at dietary dosages of 4, 18, and 80 mg/kg/day. In mice, these doses are 26 to 520 times or 2 to 35 times the maximum 10 mg human dose on a mg/kg or mg/m2 basis, respectively. In rats these doses are 43 to 876 times or 6 to 115 times the maximum 10 mg human dose on a mg/kg or mg/m2 basis, respectively. No evidence of carcinogenic potential was observed in mice. Renal liposarcomas were seen in 4/100 rats (3 males, 1 female) receiving 80 mg/kg/day and a renal lipoma was observed in one male rat at the 18 mg/kg/day dose. Incidence rates of lipoma and liposarcoma for zolpidem were comparable to those seen in historical controls and the tumor findings are thought to be a spontaneous occurrence.

Mutagenesis: Zolpidem did not have mutagenic activity in several tests including the Ames test, genotoxicity in mouse lymphoma cells in vitro, chromosomal aberrations in cultured human lymphocytes, unscheduled DNA synthesis in rat hepatocytes in vitro, and the micronucleus test in mice.

Impairment of fertility: In a rat reproduction study, the high dose (100 mg base/kg) of zolpidem resulted in irregular estrus cycles and prolonged precoital intervals, but there was no effect on male or female fertility after daily oral doses of 4 to 100 mg base/kg or 5 to 130 times the recommended human dose in mg/m2. No effects on any other fertility parameters were noted.

14 CLINICAL STUDIES

14.1 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 zolpidem (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.

Normal elderly adults (mean age 68) experiencing transient insomnia (n = 35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality).

14.2 Chronic insomnia

Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV™). Adult outpatients with chronic insomnia (n = 75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of zolpidem tartrate (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; zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Zolpidem was comparable to placebo on number of awakenings at both doses studied.

Adult outpatients (n=141) with chronic insomnia were also evaluated, in a double-blind, parallel group, 4-week trial comparing two doses of zolpidem (10 and 15 mg) and placebo. 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. Zolpidem 15 mg was superior to placebo on a subjective measure of total 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.

14.3 Studies pertinent to safety concerns for sedative/hypnotic drugs

Next-day residual effects: Next-day residual effects of zolpidem tartrate tablets were evaluated in seven studies involving normal volunteers. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of zolpidem tartrate tablets in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness.

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 zolpidem tartrate tablets. There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg.

Memory impairment: Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of zolpidem tartrate tablets. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), ie, these subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of zolpidem tartrate tablets, predominantly at doses above 10 mg.

Effects on sleep stages: In studies that measured the percentage of sleep time spent in each sleep stage, zolpidem tartrate tablets have 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How supplied

Zolpidem tartrate tablets, 5 mg are pink, caplet-shaped, biconvex, unscored, film-coated tablets engraved WPI on one side and 3366 on the other side and supplied as:

NDC Number Size
0591-3366-01 bottle of 100
0591-3366-05 bottle of 500

Zolpidem tartrate tablets, 10 mg are white, caplet-shaped, biconvex, unscored, film-coated tablets engraved WPI on one side and 3367 on the other side and supplied as:

NDC Number Size
0591-3367-01 bottle of 100
0591-3367-05 bottle of 500

16.2 Storage and handling

Store at 20°–25°C (68°–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 tartrate tablets 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 tartrate tablets.

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.

SAFE USE OF SLEEPING MEDICINES

To ensure the safe and effective use of zolpidem tartrate tablets or any other sleep medicine, you should observe the following cautions:

  1. Zolpidem tartrate tablets is a prescription medicine and should be used ONLY as directed by your doctor. Follow your doctor’s instructions about how to take, when to take, and how long to take zolpidem tartrate tablets.

  2. Never use zolpidem tartrate tablets or any other sleep medicine for longer than directed by your doctor.

  3. If you develop an allergic reaction such as a rash, hives, shortness of breath, or swelling of your tongue or throat when using zolpidem tartrate tablets or any other sleep medicine, discontinue zolpidem tartrate tablets or other sleep medicine immediately and contact your doctor.

  4. If you notice any unusual and/or disturbing thoughts or behavior during treatment with zolpidem tartrate tablets or any other sleep medicine, contact your doctor.

  5. Tell your doctor about any medicines you may be taking, including medicines you may buy without a prescription. You should also tell your doctor if you drink alcohol. DO NOT use alcohol while taking zolpidem tartrate tablets or any other sleep medicine.

  6. Do not take zolpidem tartrate tablets unless you are able to get a full night’s sleep before you must be active again. For example, zolpidem tartrate tablets should not be taken on an overnight airplane flight of less than 7 to 8 hours since “traveler’s amnesia” may occur.

  7. Do not increase the prescribed dose of zolpidem tartrate tablets or any other sleep medicine unless instructed by your doctor.

  8. 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.

  9. Be aware that you may have more sleeping problems the first night or two after stopping zolpidem tartrate tablets or any other sleep medicine.

  10. 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 tartrate tablets.

  11. As with all prescription medicines, never share zolpidem tartrate tablets or any other sleep medicine with anyone else. Always store zolpidem tartrate tablets or any other sleep medicine in the original container out of reach of children.

  12. Zolpidem tartrate tablets work very quickly. You should only take zolpidem tartrate tablets right before going to bed and are ready to go to sleep.

Watson Laboratories, Inc.
Corona, CA 92880 USA

Issued: April 2007

PHARMACIST – DETACH HERE AND GIVE LEAFLET TO PATIENT

INFORMATION FOR PATIENTS TAKING ZOLPIDEM TARTRATE TABLETS C-IV

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 is 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 belongs 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 tartrate tablets 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 tartrate tablets.

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.

SAFE USE OF SLEEPING MEDICINES

To ensure the safe and effective use of zolpidem tartrate tablets or any other sleep medicine, you should observe the following cautions:

  1. Zolpidem tartrate tablets is a prescription medicine and should be used ONLY as directed by your doctor. Follow your doctor’s instructions about how to take, when to take, and how long to take zolpidem tartrate tablets.

  2. Never use zolpidem tartrate tablets or any other sleep medicine for longer than directed by your doctor.

  3. If you develop an allergic reaction such as a rash, hives, shortness of breath, or swelling of your tongue or throat when using zolpidem tartrate tablets or any other sleep medicine, discontinue zolpidem tartrate tablets or other sleep medicine immediately and contact your doctor.

  4. If you notice any unusual and/or disturbing thoughts or behavior during treatment with zolpidem tartrate tablets or any other sleep medicine, contact your doctor.

  5. Tell your doctor about any medicines you may be taking, including medicines you may buy without a prescription. You should also tell your doctor if you drink alcohol. DO NOT use alcohol while taking zolpidem tartrate tablets or any other sleep medicine.

  6. Do not take zolpidem tartrate tablets unless you are able to get a full night’s sleep before you must be active again. For example, zolpidem tartrate tablets should not be taken on an overnight airplane flight of less than 7 to 8 hours since “traveler’s amnesia” may occur.

  7. Do not increase the prescribed dose of zolpidem tartrate tablets or any other sleep medicine unless instructed by your doctor.

  8. 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.

  9. Be aware that you may have more sleeping problems the first night or two after stopping zolpidem tartrate tablets or any other sleep medicine.

  10. 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 tartrate tablets.

  11. As with all prescription medicines, never share zolpidem tartrate tablets or any other sleep medicine with anyone else. Always store zolpidem tartrate tablets or any other sleep medicine in the original container out of reach of children.

  12. Zolpidem tartrate tablets work very quickly. You should only take zolpidem tartrate tablets right before going to bed and are ready to go to sleep.

Watson Laboratories, Inc.
Corona, CA 92880 USA

Issued: April 2007

ZOLPIDEM TARTRATE
zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3366
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zolpidem Tartrate (Zolpidem) Zolpidem 5 mg
Inactive Ingredients
Ingredient Name Strength
colloidial silicon dioxide
crosprovidone
hypromellose
iron oxide red
lactose monohydrte
magnesium stearate
microcrystalline cellulose
polyethylene glycol
polysorbate 80
titanium dioxide
Product Characteristics
Color PINK Score no score
Shape OVAL (caplet-shaped) Size 10mm
Flavor Imprint Code WPI;3366
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3366-01 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0591-3366-05 500 TABLET (500 TABLET) in 1 BOTTLE None
ZOLPIDEM TARTRATE
zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3367
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zolpidem Tartrate (Zolpidem) Zolpidem 10 mg
Inactive Ingredients
Ingredient Name Strength
colloidial silicon dioxide
crosprovidone
hypromellose
lactose monohydrte
magnesium stearate
microcrystalline cellulose
polyethylene glycol
polysorbate 80
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (caplet-shaped) Size 10mm
Flavor Imprint Code WPI;3367
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3367-01 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0591-3367-05 500 TABLET (500 TABLET) in 1 BOTTLE None
Labeler — Watson Laboratories

Revised: 05/2007 Watson Laboratories

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