ZOLPIDEM (1.75 OR 3.5 MG) - SUBLINGUAL

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ZOLPIDEM (1.75 OR 3.5 MG) - SUBLINGUAL

PHONETIC PRONUNCIATION: (ZOL-pi-dem)

COMMON BRAND NAME(S): Intermezzo

GENERIC NAME(S): zolpidem tartrate

Uses

USES: This medication is used to treat a certain type of sleep problem (insomnia) in adults who have trouble falling back asleep after waking up in the middle of the night. It helps you return to sleep faster so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication should only be taken if you have at least 4 hours of bedtime left. Zolpidem is usually limited to short treatment periods of 1 to 2 weeks or less.


How to use ZOLPIDEM (1.75 OR 3.5 MG) - SUBLINGUAL

HOW TO USE: Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start taking zolpidem and each time you get a refill. If you have any questions, ask your doctor or pharmacist. If you wake up in the middle of the night and have trouble falling asleep again, take this medication as directed by your doctor, usually only once a night if needed. Only take it if you have at least 4 hours of bedtime left, otherwise you may still be drowsy in the morning. Do not take this medication with alcohol, or if you have had alcohol that day, especially in the evening or before bed. Also do not take this medication with other drugs to help you sleep. Do not remove the medication from the pouch until you are ready to take it. Since zolpidem works quickly, take it while you are in bed. It is best to take it on an empty stomach. Do not take zolpidem with or after a meal because it will not work as quickly. Place the tablet under your tongue and let it break apart completely before swallowing. Do not swallow the tablet whole. The dosage is based on your gender, age, medical condition, response to treatment, and other medications you may be taking. Women are usually prescribed a lower dose because it is removed from the body more slowly than in men. Older adults are usually prescribed a lower dose to decrease the risk of side effects. Do not increase your dose, take it more often, or use it for longer than prescribed. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea, vomiting, flushing, stomach cramps, nervousness, shakiness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. Tell your doctor if your condition persists after 7 to 10 days, or if it worsens. You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1-2 nights. If this effect continues, contact your doctor.

Side Effects

SIDE EFFECTS: Dizziness may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly. This medication may make you sleepy during the day, especially if you do not take it as instructed (see the How to Use section). Tell your doctor or pharmacist if you have daytime drowsiness. Your dose may need to be adjusted. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety). Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of sleepwalking, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis). Since this drug makes you drowsy, wait at least 4 hours after taking a dose and until you feel completely awake before doing any activity. This medication may increase the risk of falls. You may also experience dizziness or blurred/double vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Children may be more sensitive to the side effects of this drug, especially dizziness and hallucinations. Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. Discuss the risks and benefits with your doctor. A small amount of this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: sodium oxybate. Other medications can affect the removal of zolpidem from your body, which may affect how zolpidem works. Examples include azole antifungals (such as ketoconazole), rifampin, St. John's Wort, among others. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other drugs for sleep or anxiety (such as alprazolam, lorazepam, zopiclone), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slowed breathing or a deep sleep from which you cannot be awakened.

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Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.