Zolpidem spray - oral
Zolpidem spray - oral
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 (possibly fatal) 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. You should not take this medication or similar medications (such as eszopiclone, zaleplon) if you have this reaction to the medication.
Zolpidem is used for a short time to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep 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.
Read the Medication Guide and the Patient Instructions for Use provided by your pharmacist before you start using zolpidem and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Prime the product according to the instructions before you use it for the first time and if you have not used it for at least 14 days. Point the spray away from your face and other people while you are priming it.
Spray this medication into your mouth over your tongue as directed by your doctor, usually once a night. Since zolpidem works quickly, use it right before you get into bed. Use it on an empty stomach. Do not use it with or right after a meal because it will not work as quickly.
Do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss and may have trouble safely doing any activity that requires alertness, such as driving or operating machinery. (See also Precautions section.)
Dosage is based on your gender, age, medical condition, other medications you may be taking, and response to treatment. Do not increase your dose, use it more often, or use it for longer than prescribed. Do not use more than 10 milligrams a day. Women are usually prescribed a lower dose because the drug 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.
If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea, vomiting, flushing, stomach cramps, nervousness, shakiness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used zolpidem for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.
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.
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.
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 using 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.
See also Warning section.
Dizziness may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.
Tell your doctor if you are drowsy during the day. 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:
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:
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.
See also Warning section.
Before using 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:
The effects of this drug can last even after you wake up the next day. If you did not get 7 to 8 hours of sleep or took other medications that made you sleepy or are more sensitive to this drug, you may feel alert but not think clearly enough to drive. You may also experience dizziness or blurred/double vision. Alcohol or marijuana (cannabis) can make you more dizzy. Wait at least 8 hours after taking this drug before driving, and do not drive, use machinery, or do anything that needs alertness until you can do it safely. This medication may also increase the risk of falls. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
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. Babies born to mothers who have used this drug late in the last 3 months of pregnancy may develop unusual sleepiness, trouble breathing, unusual limpness, or withdrawal symptoms. Get medical help right away if you notice any unusual symptoms in your newborn. Discuss the risks and benefits with your doctor.
A small amount of this medication passes into breast milk and may have undesirable effects on a nursing infant (such as unusual sleepiness, trouble breathing, or unusual limpness). Get medical help right away if you notice any unusual symptoms in your baby. Ask your doctor if you should pump and discard your breast milk during treatment and for 23 hours after a dose of this medication to lessen the risk of these effects in your baby. Consult your doctor before breast-feeding.
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:
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 (cannabis), 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.
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.
Do not share this medication with others. Sharing it is against the law.
As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.
If you miss a dose, do not use it unless you have time to sleep for 7 to 8 hours afterwards.
Store upright at room temperature. Keep away from heat. Do not freeze. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
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.
Information last revised August 2019.
Copyright(c) 2019 First Databank, Inc.
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.