Category Archives: zolpidem dosage

MEDICATION GUIDE - Zolpidem Tartrate Tablets C-IV

Read the Medication Guide that comes with Zolpidem Tartrate Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Zolpidem Tartrate Tablets?

After taking Zolpidem Tartrate Tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Zolpidem Tartrate Tablets. Reported activities include:

• driving a car (‘sleep-driving’)
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking Zolpidem Tartrate Tablets.

Important:
1. Take Zolpidem Tartrate Tablets exactly as prescribed

• Do not take more Zolpidem Tartrate Tablets than prescribed.
• Take Zolpidem Tartrate Tablets right before you get in bed, not sooner.

2. Do not take Zolpidem Tartrate Tablets if you:

• drink alcohol
• take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Zolpidem Tartrate Tablets with your other medicines.
• cannot get a full night”s sleep

What is Zolpidem Tartrate Tablets?
Zolpidem Tartrate is a sedative-hypnotic (sleep) medicine. Zolpidem Tartrate is used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include:

• trouble falling asleep

Zolpidem Tartrate tablets are not for children.

Who should not take Zolpidem Tartrate Tablets?
Do not take Zolpidem Tartrate Tablets if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Zolpidem Tartrate Tablets.

Zolpidem Tartrate Tablets may not be right for you. Before starting Zolpidem Tartrate Tablets , tell your doctor about all of your health conditions, including if you:

• have a history of depression, mental illness or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take Zolpidem Tartrate Tablets with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take Zolpidem Tartrate Tablets?

• Take Zolpidem Tartrate Tablets exactly as prescribed. Do not take more Zolpidem Tartrate Tablets than prescribed for you.
• Take Zolpidem Tartrate Tablets right before you get into bed.
• Do not take Zolpidem Tartrate Tablets unless you are able to stay in bed a full night (7-8 hours) before being active again.
• For faster sleep onset, Zolpidem Tartrate Tablets should NOT be taken with or immediately after a meal.
• Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much Zolpidem Tartrate Tablets or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of Zolpidem Tartrate Tablets? Serious side effects of Zolpidem Tartrate Tablets include:

• getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about Zolpidem Tartrate Tablets?’)
• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Zolpidem Tartrate Tablets.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Zolpidem Tartrate Tablets.

The most common side effects of Zolpidem Tartrate Tablets are:

• drowsiness
• dizziness
• diarrhea
• “drugged feelings”
• You may still feel drowsy the next day after taking Zolpidem Tartrate Tablets. Do not drive or do other dangerous activities after taking Zolpidem Tartrate Tablets until you feel fully awake.

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as: trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain.

These are not all the side effects of Zolpidem Tartrate Tablets. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Zolpidem Tartrate Tablets?

• Store Zolpidem Tartrate Tablets at room temperature, 68° to 77°F (20° to 25° C).
• Keep Zolpidem Tartrate Tablets and all medicines out of reach of children.

General Information about Zolpidem Tartrate Tablets

• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Do not use Zolpidem Tartrate Tablets for a condition for which it was not prescribed.
• Do not share Zolpidem Tartrate Tablets with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Zolpidem Tartrate Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zolpidem Tartrate Tablets that is written for healthcare professionals. For more information about Zolpidem Tartrate Tablets, call West-ward Pharmaceutical Corp. at 732-542-1191.

What are the ingredients in Zolpidem Tartrate Tablets?

Active Ingredient: Zolpidem tartrate

Inactive Ingredients: low substituted hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide; the 5-mg tablet also contains black iron oxide & red iron oxide.

SEVERE ANAPHYLACTIC AND ANAPHYLACTOID REACTIONS

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with Zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immedidately if any of them occur.

There have been reports of people getting out of bed after taking a sedative-hypnotic 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 central nervous system depressants [see Warnings . Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in people who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, people usually do not remember these events.

Patients should be instructed NOT to take Zolpidem tartrate tablets or other sedative-hypnotics when drinking alcohol. In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be counseled to take Zolpidem tartrate tablets right before they get in bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Patients should be instructed to report events such as sleep-driving and other complex behaviors immediately to the prescriber.

Zolpidem  Patient Counseling Information

Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with sedative-hypnotics should counsel them in its appropriate use, and should instruct them to read the accompanying Medication Guide [see Medication Guide .

Zolpidem How Supplied/Storage and Handling

Zolpidem tartrate 5 mg and 10 mg tablets are supplied in bottles of 100 and bottles of 500.

Zolpidem tartrate tablets 5 mg are oval-shaped, brick red, film coated, 10 x 4.5 mm tablets, imprinted with W62 on one side. The 10 mg tablets are oval-shaped, white, film coated, 10 x 4.5 mm tablets, imprinted with W63 on one side. Tablets are not scored.

Store at controlled room temperature 20°-25° C (68°-77°F).

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 base/kg. In mice, these doses are approximately 2.5, 10, and 50 times the maximum recommended human dose (MRHD) of 10 mg/day (8 mg Zolpidem base) on mg/m2 basis. In rats, these doses are approximately 5, 20, and 100 times the MRHD on a mg/m2 basis. No evidence of carcinogenic potential was observed in mice. In rats, renal tumors (lipoma, liposarcoma) were seen at the mid- and high doses.

Mutagenesis: Zolpidem was negative in in vitro (bacterial reverse mutation, mouse lymphoma, and chromosomal aberration) and in vivo (mouse micronucleus) genetic toxicology assays.

Impairment of fertility: Oral administration of Zolpidem (doses of 4, 20, and 100 mg base/kg or approximately 5, 24, and 120 times the MRHD on a mg//m2 basis) to rats prior to and during mating, and continuing in females through postpartum day 25, resulted in irregular estrus cycles and prolonged precoital intervals. The no-effect dose for these findings is approximately 24 times the MRHD on a mg/m2 basis. There was no impairment of fertility at any dose tested.

Contraindications

Zolpidem tartrate is contraindicated in patients with known hypersensitivity to Zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions .

 Drug Abuse and Dependence

CONTROLLED SUBSTANCE

Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.

ABUSE

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.

Studies of abuse potential in former drug abusers found that the effects of single doses of Zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while Zolpidem tartrate 10 mg was difficult to distinguish from placebo.

Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of Zolpidem, they should be monitored carefully when receiving Zolpidem or any other hypnotic.

DEPENDENCE

Physical dependence is a state of adptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.

Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following adverse eventswhich are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last Zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received.

 Zolpidem Dosage and Administration

The dose of Zolpidem tartrate tablets should be individualized.

DOSAGE IN ADULTS

The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Zolpidem tartrate tablets dose should not exceed 10 mg per day.

SPECIAL POPULATIONS

Elderly or debilitated patients may be especially sensitive to the effects of Zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem tartrate tablets in both of these patient poulations is 5 mg once daily immediately before bedtime. [see Warnings and Precautions .

USE WITH CNS DEPRESSANTS

Dosage adjustment may be necessary when Zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions .

ADMINISTRATION

The effect of Zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

Dosage Forms and Strengths

Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.

Zolpidem tartrate tablets 5 mg are oval-shaped, brick red, film coated, 10 × 4.5 mm tablets, imprinted with W62 on one side.

The 10 mg tablets are oval-shaped, white, film coated, 10 × 4.5 mm tablets, imprinted with W63 on one side.