Complete SPL Sections
1 INDICATIONS AND USAGE
Indications & Usage Section
Zolpidem tartrate extended-release tablets, USP are indicated for the 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 with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3) ].
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: CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.1 )] Serious anaphylactic and anaphylactoid reactions [see Warnings and Precautions ( 5.3 )] Abnormal thinking and behavior changes, and complex behaviors [see Warnings and Precautions ( 5.4 )] Withdrawal effects [see Warnings and Precautions ( 5.8) ]
7 DRUG INTERACTIONS
Drug Interactions Section
8 USE IN SPECIFIC POPULATIONS
Use In Specific Populations Section
Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester. ( 8.1 ) Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after zolpidem tartrateadministration. ( 8.2 ) Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse
9 DRUG ABUSE AND DEPENDENCE
Drug Abuse And Dependence Section
10 OVERDOSAGE
Overdosage Section
11 DESCRIPTION
Description Section
Zolpidem tartrate extended-release tablets, USP contain 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
Product: 50090-4479 NDC: 50090-4479-0 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
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. 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. 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. Sleep-Driving and other Complex Behaviors Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior change, including “sleep driving” and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients to call you immediately if they develop any of these symptoms. 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. 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
Zolpidem Tartrate (zole-PI-dem TAR-trate) Extended-Release Tablets, USP C-IV Read the Medication Guide that comes with zolpidem tartrate extended-release 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 extended-release tablets? Do not take more zolpidem tartrate extended-release tablets than prescribed. Do not take zolpidem tartrate extended-release 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 extended-release tablets right before you get in bed, not sooner. Zolpidem tartrate extended-release tablets may cause serious side effects that you may not know are happening to you. These side effects include: sleepiness during the day not thinking clearly act strangely, confused, or upset “sleep-walking” or doing other activities when you are asleep like: o eating o talking o having sex o driving a car Call 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. You should not drive a car or do things that require clear thinking the day after you take zolpidem tartrate extended-release tablets. Do not take zolpidem tartrate extended-release tablets if you: drank alcohol that evening or before bed. take other medicines that can make you sleepy. Taking zolpidem tartrate extended-release tablets with other drugs can cause side effects. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take zolpidem tartrate extended-release tablets with your other medicines. cannot get a full night’s sleep. What are zolpidem tartrate extended-release tablets? Zolpidem tartrate extended-release tablets are a sedative-hypnotic (sleep) medicine. Zolpidem tartrate extended-release tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include: trouble falling asleep waking up often during the night Zolpidem tartrate extended-release tablets are not recommended for use in children under the age of 18 years. Zolpidem tartrate extended-release tablets are 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 prevent misuse and abuse. Selling or giving away zolpidem tartrate extended-release 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 extended-release tablets? Do not take zolpidem tartrate extended-release tablets if you are allergic to zolpidem or any other 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. Do not take zolpidem tartrate extended-release tablets if you have had an allergic reaction to drugs containing zolpidem, such as Ambien*, 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 extended-release tablets? Zolpidem tartrate extended-release tablets may not be right for you. Before starting zolpidem tartrate extended-release 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 extended-release tablets. Using zolpidem tartrate extended-release 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), trouble breathing, or limpness in the newborn if zolpidem tartrate extended-release tablets is taken late in pregnancy. 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 nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take zolpidem tartrate extended-release 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 extended-release tablets? See “What is the most important information I should know about zolpidem tartrate extended-release tablets?” Take zolpidem tartrate extended-release tablets exactly as prescribed. Only take 1 zolpidem tartrate extended-release tablet a night if needed. Do not take zolpidem tartrate extended-release tablets if you drank alcohol that evening or before bed. 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. Take zolpidem tartrate extended-release tablets whole. Do not break, crush, dissolve or chew zolpidem tartrate extended-release tablets before swallowing. 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 insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. If you take too many zolpidem tartrate extended-release tablets or overdose, get emergency treatment. What are the possible side effects of zolpidem tartrate extended-release tablets? Zolpidem tartrate extended-release tablets may cause serious side effects including: getting out of bed while not being fully awake and doing an activity that you do not know you are doing. (See “What is the most important information I should know about zolpidem tartrate extended-release 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 extended-release 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 extended-release tablets. The most common side effects of zolpidem tartrate extended-release tablets are: headache sleepiness dizziness drowsiness the next day after you take zolpidem tartrate extended-release tablets 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 extended-release tablets. Ask your healthcare provider or pharmacist for more information. Call ...
Zolpidem Tartrate
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL