Edluar

Generic Name: zolpidem (zole PI dem)
Brand Names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

What is Edluar?

Edluar (zolpidem) is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Edluar sublingual tablets are used for the short treatment of insomnia where individuals are finding it difficult to fall asleep.

Edluar may also be used for purposes not listed in this medication guide.

Important information

In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for Edluar. 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.

Do not share this medication with another person, even if they have the same symptoms you have. Edluar is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Slideshow: Insomnia Treatment with Non-Benzodiazepines Ambien, Lunesta & Sonata

Edluar may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Edluar and talk with your doctor about another treatment for your sleep disorder.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Zolpidem may be habit forming. Keep the medication in a place where others cannot get to it.

Edluar may cause a severe allergic reaction. Stop taking Edluar 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.

Before taking this medicine

Some people using Edluar have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Edluar and talk with your doctor about another treatment for your sleep disorder.

You should not use this medication if you are allergic to zolpidem.

To make sure Edluar 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.

Edluar may be habit forming and should be used only by the person it was prescribed for. Never share Edluar 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.

FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Edluar may be stronger in older adults.

Do not give this medicine to anyone younger than 18 years of age.

It is dangerous to try and purchase Edluar 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. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

How should I take Edluar?

In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for Edluar. 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 this medicine in larger amounts, or for longer than prescribed.

Do not share this medication with another person, even if they have the same symptoms you have. Edluar is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Edluar comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not swallow the Edluar tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.

Never take Edluar if you do not have a full 7 to 8 hours to sleep before being active again.

Edluar 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 this medicine for longer than 4 or 5 weeks without your doctor's advice.

Do not stop using Edluar suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking Edluar. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Edluar is taken only at bedtime, you will not be on a frequent dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Edluar can be fatal 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?

Edluar may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. 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.

Avoid taking Edluar during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Edluar.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Edluar side effects

Edluar may cause a severe allergic reaction. Stop taking Edluar 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.

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 Edluar 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 Edluar 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.

See also: Side effects (in more detail)

What other drugs will affect Edluar?

You may need a lower dose of Edluar if you take other medicines that make you sleepy or slow your breathing (such as cold medicine, pain medication, muscle relaxants, and medicine for depression, anxiety, or seizures). Tell your doctor if you are currently taking any of these medications.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Edluar, especially:

  • chlorpromazine;

  • itraconazole or ketoconazole;

  • rifampin; or

  • an antidepressant--imipramine, sertraline.

This list is not complete. Other drugs may interact with Edluar, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Edluar.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
  • Disclaimer: 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 1996-2014 Cerner Multum, Inc. Version: 8.02. Revision Date: 2013-05-15, 3:09:39 PM.

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