ZOLPIDEM TARTRATE

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 tartrate tablets. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate 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 10 mg tablets, USP are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and '10 MG' debossed on the other side and supplied as: NDC Number Size 82868-064-30 bottle of 30 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 patient to read the FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with zolpidem tartrate tablets. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with zolpidem tartrate tablets 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 tartrate tablets 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 tartrate tablets 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 tartrate tablets 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 tartrate tablets if they drank alcohol that evening or before bed. Concomitant Use with Opioids Inform patients and caregivers that potentially serious additive effects may occur if zolpidem tartrate tablets is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.2 , 5.7 ), Drug Interactions ( 7.1 )] . Tolerance, Abuse, and Dependence Tell patients not to increase the dose of zolpidem tartrate tablets on their own, and to inform you if they believe the drug "does not work". Administration Instructions Patients should be counseled to take zolpidem tartrate tablets 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 tartrate tablets 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 )] . Dispense with Medication Guide available at: https://torrentpharma.com/pi/usa/products/ Manufactured by: Torrent Pharmaceuticals LTD., India. 8097534 Revised: August 2024 or Manufactured by: Piramal Pharma Limited, Pithampur - 454775, India. 8097495 Revised: August 2024 Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920.

SPL MEDGUIDE SECTION

SPL MEDGUIDE SECTION

Dispense with Medication Guide available at: https://torrentpharma.com/pi/usa/products/ MEDICATION GUIDE Z olpidem Tartrate (zole-PI-dem TAR-trate) Tablets USP, for oral use C-IV What is the most important information I should know about zolpidem tartrate tablets? Zolpidem tartrate tablets may cause serious side effects, including: Complex sleep behaviors. 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. These activities may happen with zolpidem tartrate tablets whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking zolpidem tartrate tablets have reported: o sleep-walking o sleep-driving o making and eating food o talking on the phone o having sex Stop taking zolpidem tartrate tablets and tell your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets. What are zolpidem tartrate tablets? Zolpidem tartrate tablets is a prescription sleep medicine used for the short-term treatment of adults who have trouble falling asleep (insomnia). • It is not known if zolpidem tartrate tablets is safe and effective in children under the age of 18 years. Zolpidem tartrate tablets is not recommended for use in children under the age of 18 years. • Zolpidem tartrate tablets are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate tablets in a safe place to protect it from theft. Never give your zolpidem tartrate tablets to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law. Do not take zolpidem tartrate tablets if you: • have had complex sleep behaviors that happened after taking zolpidem tartrate tablets in the past. See “What is the most important information I should know about zolpidem tartrate tablets?” • are allergic to zolpidem or any of the ingredients in zolpidem tartrate tablets. See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate tablets. Before taking zolpidem tartrate tablets, tell your healthcare provider about all of your medical conditions, including if you: have a history of depression, mental illness, or suicidal thoughts or actions have a history of drug or alcohol abuse or addiction have kidney or liver disease have a lung disease or breathing problems have sleep apnea have myasthenia gravis are pregnant or plan to become pregnant. Taking zolpidem tartrate tablets in the third trimester of pregnancy may harm your unborn baby. o Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with zolpidem tartrate tablets. o Babies born to mothers who take zolpidem tartrate tablets during the third trimester of pregnancy may have symptoms of breathing problems and sedation (such as sleepiness or low muscle tone) are breastfeeding or plan to breastfeed. Zolpidem tartrate passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with zolpidem tartrate tablets. Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Zolpidem tartrate tablets and other medicines can interact with each other causing serious side effects. Zolpidem tartrate tablets may affect the way other medicines work, and other medicines may affect how zolpidem tartrate tablets works. Especially tell your healthcare provider if you: take benzodiazepines take opioids as it may increase the risk of breathing problems (respiratory depression) take tricyclic antidepressants take other medicines that can make you sleepy or affect your breathing (including other zolpidem medicines) drink alcohol You can ask your pharmacist for a list of medicines that interact with zolpidem tartrate tablets. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take zolpidem tartrate tablets? Take zolpidem tartrate tablets exactly as prescribed. Do not change your dose on your own. Tell your healthcare provider if you think zolpidem tartrate tablets is not working for you. Zolpidem tartrate tablets is for short-term use only. Treatment with zolpidem tartrate tablets should be as short as possible because the risk of dependence increases the longer you are being treated. Take 1 zolpidem tartrate tablet at night right before bedtime. Do not take zolpidem tartrate tablets if you are not able to stay in bed a full night (7 to 8 hours) before you must be active again. You should not take zolpidem tartrate tablets with or right after a meal. Zolpidem tartrate tablet may help you fall asleep faster if you take it on an empty stomach. Do not take zolpidem tartrate tablets if you drank alcohol that evening or before bed. Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. If you take too much zolpidem tartrate tablets, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of zolpidem tartrate tablets? Zolpidem tartrate tablets may cause serious side effects, including: See “ What is the most important information I should know about zolpidem tartrate tablets? ” Zolpidem tartrate tablets can make you sleepy or dizzy and can slow your thinking and motor skills. Because zolpidem tartrate tablets can make you sleepy or dizzy you are at a higher risk for falls. o Do not drive, operate heavy machinery, or do other dangerous activities until you know how zolpidem tartrate tablets affects you. o Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking zolpidem tartrate tablets without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, zolpidem tartrate tablets may make your sleepiness or dizziness much worse. Severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help right away if you develop any of these symptoms during treatment with zolpidem tartrate tablets. Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion (delirium), acting strangely, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions. Risk of suicide and worsening of depression. Worsening of depression, including suicidal thoughts and actions can happen during treatment with medicines like zolpidem tartrate tablets. Call your healthcare provider right away if you develop any thoughts of suicide, dying, or worsening depression during treatment with zolpidem tartrate tablets. Breathing problems. See “ Before taking zolpidem tartrate tablets, tell your healthcare provider about all of your medical conditions, including if you: ” Call your healthcare provider or get emergency medical help right away if you develop breathing problems during treatment with zolpidem tartrate tablets. Problems with your nervous system caused by severe liver disease (hepatic encephalopathy). Withdrawal symptoms. You may have withdrawal symptoms if you stop taking zolpidem tartrate tablets suddenly. Withdrawal symptoms can be serious and include stomach and muscle cramps, vomiting, sweating, shakiness, seizures, and confusion (delirium).Talk to your healthcare provider about slowly stopping zolpidem tartrate tablets to avoid withdrawal symptoms. The most common side effects of zolpidem tart...

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82868-064-30