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 tartrate extended-release tablets. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate extended-release tablets immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
Indications & Usage Section
Zolpidem tartrate extended-release tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies ( 14 )] .
2 DOSAGE AND ADMINISTRATION
Dosage & Administration Section
3 DOSAGE FORMS AND STRENGTHS
Dosage Forms & Strengths Section
Zolpidem tartrate extended-release tablets, USP are available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored. Zolpidem tartrate extended-release tablets, USP 6.25 mg are round biconvex bi-layer coated tablets with pink layer and white layer and imprinted with “307” on one side and other side plain. Zolpidem tartrate extended-release tablets, USP 12.5 mg are round biconvex bi-layer coated tablets with yellow layer and white layer and imprinted with “308” on one side and other side plain.
4 CONTRAINDICATIONS
Contraindications Section
Zolpidem tartrate extended-release tablets are contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets [see Warnings and Precautions (5.1)]. with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4)].
5 WARNINGS AND PRECAUTIONS
Warnings And Precautions Section
6 ADVERSE REACTIONS
Adverse Reactions Section
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions (5.1)] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2)] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions (5.4)] Abnormal Thinking and Behavior Changes [see Warnings and Precautions (5.5)] Withdrawal Effects [see Warnings and Precautions (5.9)]
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 extended-release tablets, USP contains zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate extended-release tablets, USP are available in 6.25 mg and 12.5 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 is a white to off-white crystalline powder that is slightly soluble in water, sparingly soluble in alcohol, and propylene glycol. It has a molecular weight of 764.86. Zolpidem tartrate extended-release tablets, USP consist of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide red, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80. The 12.5 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide yellow, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, and ammonium hydroxide. It meets USP Dissolution Test 2.
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 extended-release tablets, USP, 6.25 mg are round biconvex bi-layer coated tablets with pink layer and white layer and imprinted with “307” on one side and plain on other side. Zolpidem tartrate extended-release tablets, USP, 6.25 mg are supplied as follows: Bottles of 100 with Child Resistant Cap ………………..…... NDC 47335-307-88 Bottles of 500 .................................................…………..…... NDC 47335-307-13 Zolpidem tartrate extended-release tablets, USP, 12.5 mg are round biconvex bi-layer coated tablets with yellow layer and white layer and imprinted with “308” on one side and plain on other side. Zolpidem tartrate extended-release tablets, USP, 12.5 mg are supplied as follows: Bottles of 100 with Child Resistant Cap ………………..…... NDC 47335-308-88 Bottles of 500 ................................................…………..…... NDC 47335-308-13 Storage: Store zolpidem tartrate extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 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 extended-release 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 extended-release tablets and with each prescription refill. Review the zolpidem tartrate extended-release tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that zolpidem tartrate extended-release tablets should be taken only as prescribed. Complex Sleep Behaviors Instruct patients and their families that zolpidem tartrate extended-release 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 extended-release 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 extended-release tablets can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients against driving and other activities requiring complete mental alertness the day after use. 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 extended-release 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 extended-release tablets is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [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 extended-release 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 extended-release tablets right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Zolpidem tartrate extended-release tablets should not be taken with or immediately after a meal. Advise patients NOT to take zolpidem tartrate extended-release 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 extended-release tablets. Advise patients that use of zolpidem tartrate extended-release tablets late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used zolpidem tartrate extended-release 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 extended-release tablets to monitor infants for increased sleepiness (more than usual), 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 extended-release tablets administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2)] .
MEDICATION GUIDE
SPL MEDGUIDE SECTION
Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products MEDICATION GUIDE Zolpidem Tartrate (zole-PI-dem TAR-trate) Extended-Release Tablets, USP C-IV What is the most important information I should know about zolpidem tartrate extended-release tablets? Zolpidem tartrate extended-release tablets may cause serious side effects, including: · Complex sleep behaviors. After taking zolpidem tartrate extended-release 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 extended-release 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 extended-release tablets have reported: sleep-walking sleep-driving making and eating food talking on the phone having sex Stop taking zolpidem tartrate extended-release 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 extended-release tablets. What is zolpidem tartrate extended-release tablets? Zolpidem tartrate extended-release tablets is a prescription sleep medicine used for the treatment of adults who have trouble falling asleep or staying asleep (insomnia). · It is not known if zolpidem tartrate extended-release tablets is safe and effective in children under the age of 18 years. Zolpidem tartrate extended-release tablets is not recommended for use in children under the age of 18 years. Zolpidem tartrate extended-release tablets is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate extended-release tablets in a safe place to protect it from theft. Never give your zolpidem tartrate extended-release tablets to anyone else because it can cause death or harm them. Selling or giving away this medicine is against the law. Do not take zolpidem tartrate extended-release tablets if you: · have had complex sleep behaviors that happened after taking zolpidem tartrate extended-release tablets in the past. See “What is the most important information I should know about zolpidem tartrate extended-release tablets? are allergic to zolpidem or any of the ingredients in zolpidem tartrate extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate extended-release tablets. Before taking zolpidem tartrate extended-release 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 extended-release 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 extended-release tablets. o Babies born to mothers who take zolpidem tartrate extended-release 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. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate extended-release 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 extended-release tablets and other medicines can interact with each other causing serious side effects. Zolpidem tartrate extended-release tablets may affect the way other medicines work, and other medicines may affect how zolpidem tartrate extended-release tablets work. 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 extended-release 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 extended-release tablets? · Take zolpidem tartrate extended-release tablets exactly as prescribed. Do not change your dose on your own. Tell your healthcare provider if you think zolpidem tartrate extended-release tablets is not working for you. · Zolpidem tartrate extended-release tablets is for short-term use only . Treatment with zolpidem tartrate extended-release tablets should be as short as possible because the risk of dependence increases the longer you are being treated. · Take 1 zolpidem tartrate extended-release tablets a night right before bedtime. · Do not take zolpidem tartrate extended-release 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 extended-release tablets with or right after a meal. Zolpidem tartrate extended-release tablets may help you fall asleep faster if you take it on an empty stomach. · Do not take zolpidem tartrate extended-release tablets if you drank alcohol that evening or before bed. · Swallow zolpidem tartrate extended-release tablets whole. Do not divide, crush, or chew zolpidem tartrate extended-release tablets. If you cannot swallow zolpidem tartrate extended-release tablets whole, tell your healthcare provider. You may need a different medicine. · 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 extended-release tablets, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of zolpidem tartrate extended-release tablets? Zolpidem tartrate extended-release tablets may cause serious side effects including: · See “What is the most important information I should know about zolpidem tartrate extended-release tablets?” · Zolpidem tartrate extended-release tablets can make you sleepy or dizzy and can slow your thinking and motor skills. Next-day sleepiness is common, but can be serious. Because zolpidem tartrate extended-release 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 extended-release 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 extended-release tablets without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, zolpidem tartrate extended-release 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 if you get these symptoms after taking zolpidem tartrate extended-release 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...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label 6.25 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-307-88 Zolpidem Tartrate Extended-Release Tablets, USP C-IV 6.25 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 100 Tablets SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label 12.5 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-308-88 Zolpidem Tartrate Extended-Release Tablets, USP C-IV 12.5 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 100 Tablets SUN PHARMA