Complete SPL Sections#
WARNING: COMPLEX SLEEP BEHAVIORS
BOXED WARNING SECTION
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartare tablets. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartare tablets immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].
RECENT MAJOR CHANGES
RECENT MAJOR CHANGES SECTION
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
9 DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
11 DESCRIPTION
DESCRIPTION SECTION
Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N ,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure: Zolpidem tartrate, USP 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 zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Zolpidem tartrate 5 mg tablets, USP are red colored, capsule shaped tablets with the Torrent logo debossed on one side and 5 MG debossed on the other side and supplied as NDC Number 68071-2450-2 BOTTLES OF 2 Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59º to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patients to read the FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with zolpidem. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with zolpidem and with each prescription refill. Review the zolpidem tartrate tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that zolpidem tartrate tablets should be taken only as prescribed. Complex Sleep Behaviors Instruct patients and their families that zolpidem may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue zolpidem and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning, Warnings and Precautions ( 5.1 )] . CNS-Depressant Effects and Next-Day Impairment Tell patients that zolpidem has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions ( 5.2 )] . 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 immediately if any of them occur [see Warnings and Precautions ( 5.4 )] . Suicide Tell patients to immediately report any suicidal thoughts. Alcohol and Other Drugs Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use zolpidem if they drank alcohol that evening or before bed. Tolerance, Abuse, and Dependence Tell patients not to increase the dose of zolpidem on their own, and to inform you if they believe the drug "does not work". Administration Instructions Patients should be counseled to take zolpidem right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again. Zolpidem tartrate tablets should not be taken with or immediately after a meal. Advise patients NOT to take zolpidem if they drank alcohol that evening. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with zolpidem tartrate tablets. Advise patients that use of zolpidem tartrate tablets late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used zolpidem tartrate tablets during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations ( 8.1 )]. Lactation Advise breastfeeding mothers using zolpidem tartrate tablets to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after zolpidem tartrate tablets administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations ( 8.2 )] . Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA. Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. 8076676 Revised September 2019
SPL MEDGUIDE SECTION
SPL MEDGUIDE SECTION
MEDICATION GUIDE Z olpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP 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 healthcare provider about your medical condition or treatment. What is the most important information I should know about zolpidem tartrate tablets? Do not take more zolpidem tartrate tablets than prescribed . Do not take zolpidem tartrate tablets unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again . Take zolpidem tartrate tablets right before you get in bed, not sooner. Zolpidem tartrate tablets may cause serious side effects, including: complex sleep behaviors that have caused serious injury and death. 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 (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with zolpidem tartrate tablets whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities include: o driving a car ("sleep-driving") o making and eating food o talking on the phone o having sex o sleep-walking Stop taking zolpidem tartrate tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets. Do not take zolpidem tartrate tablets if you: have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone , or having sex while not being fully awake) after taking zolpidem tartrate tablets. drank alcohol that evening or before bed took another medicine to help you sleep What are zolpidem tartrate tablets? Zolpidem tartrate tablets are sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets are used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep). Zolpidem tartrate tablets are not recommended for use in children under the age of 18 years. Zolpidem tartrate is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate tablets in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate tablets may harm others, and is against the law. Tell your healthcare provider if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs. Who should not take zolpidem tartrate tablets? Do not take zolpidem tartrate tablets if you are allergic to zolpidem or any other ingredients in zolpidem tartrate tablets. See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate tablets. Do not take zolpidem tartrate tablets if you have had an allergic reaction to drugs containing zolpidem, such as zolpidem tartrate CR tablets, Edluar, Zolpimist, or Intermezzo. Symptoms of a serious allergic reaction to zolpidem can include: swelling of your face, lips, and throat that may cause difficulty breathing or swallowing What should I tell my healthcare provider before taking zolpidem tartrate tablets? Zolpidem tartrate tablets may not be right for you. Before starting zolpidem tartrate tablets, tell your healthcare provider 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. Talk to your healthcare provider about the risk to your unborn baby if you take zolpidem tartrate tablets. Using zolpidem tartrate tablets in the last trimester of pregnancy may cause breathing difficulties or excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual), troublebreathing, or limpness in the newborn if zolpidem tartrate tablets is taken late in pregnancy. are breastfeeding or plan to breastfeed. Zolpidem tartrate tablets passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate tablets. Tell your healthcare provider 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 unless your healthcare provider tells you to. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine. How should I take zolpidem tartrate tablets? See "What is the most important information I should know about zolpidem tartrate tablets?" Take zolpidem tartrate tablets exactly as prescribed. Only take 1 zolpidem tartrate tablet a night if needed. Do not take zolpidem tartrate tablets if you drank alcohol that evening or before bed. You should not take zolpidem tartrate tablets with or right after a meal. Zolpidem tartrate tablets may help you fall asleep faster if you take it on an empty stomach. Call your healthcare provider 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, get emergency treatment. What are the possible side effects of zolpidem tartrate tablets? Zolpidem tartrate tablets may cause serious side effects, including: 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, and trouble breathing. Get emergency medical help if you get these symptoms after taking zolpidem tartrate tablets. Call your healthcare provider 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 grogginess or feeling as if you have been drugged 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 • stomach area pain These are not all the side effects of zolpidem tartrate tablets. Ask your healthcare provider 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 at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep zolpidem tartrate tablets and all medicines out of reach of children. General Information about the safe and effective use of 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 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 healthcare provider. You can ask your healthcar...
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
