What is the most important information I should know about zolpidem?
Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Never take zolpidem in larger amounts or for longer than prescribed.
Do not take zolpidem if you have consumed alcohol during the day or just before bed.
Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity.
What is zolpidem?
Zolpidem is a sedative, also called a hypnotic. It affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).
Zolpidem is used to treat insomnia. The immediate-release forms of zolpidem are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.
Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.
Your doctor will determine which form of zolpidem is best for you.
Zolpidem may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking zolpidem?
Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.
You should not use this medicine if you are allergic to zolpidem. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.
To make sure zolpidem is safe for you, tell your doctor if you have:
- kidney disease;
- liver disease;
- lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
- sleep apnea (breathing stops during sleep);
- myasthenia gravis;
- a history of depression, mental illness, or suicidal thoughts; or
- a history of drug or alcohol addiction.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Zolpidem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
The sedative effects of zolpidem may be stronger in older adults.
Zolpidem is not approved for use by anyone younger than 18 years old.
It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
How should I take zolpidem?
In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for Ambien, Edluar, and Zolpimist. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.
Follow all directions on your prescription label. Never take zolpidem in larger amounts, or for longer than prescribed.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Zolpidem may be habit-forming. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.
Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.
Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.
Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice.
Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using zolpidem.
Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medicine. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole.
Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.
Spray Zolpimist directly into your mouth over your tongue. Prime the spray before the first use by pumping 5 test sprays into the air, away from your face. Prime the spray with 1 test spray if it has not been used for longer than 14 days.
Store at room temperature away from moisture and heat. Do not freeze. Keep the Zolpimist bottle upright when not in use.
What happens if I miss a dose?
Since zolpidem is taken only at bedtime if needed, you are not likely to miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
What should I avoid while taking zolpidem?
Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking zolpidem, especially if you take the extended-release tablet, or if you are a woman. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.
Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
What are the possible side effects of zolpidem?
Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.
Stop using zolpidem and call your doctor at once if you have:
- chest pain, fast or irregular heartbeat, feeling short of breath;
- trouble breathing or swallowing; or
- feeling like you might pass out.
Common side effects may include:
- daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
- tired feeling, loss of coordination;
- stuffy nose, dry mouth, nose or throat irritation;
- nausea, constipation, diarrhea, upset stomach; or
- headache, muscle pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect zolpidem?
Taking zolpidem with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with zolpidem. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about zolpidem.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 11.01. Revision date: 5/1/2017.
