Edluar

Edluar is a prescription medication used in adults for the short-term treatment of insomnia (difficulty falling asleep). Edluar belongs to a group of drugs called hypnotics. It works by slowing down brain activity so you can fall asleep.

Edluar comes as a sublingual tablet and is taken by mouth at night and only if needed, without food. Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.

Common side effects of Edluar include daytime drowsiness, dizziness, and diarrhea. Do not drive or operate heavy machinery until you know how Edluar affects you.

Edluar is part of the drug class:

• Benzodiazepine related drugs

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Do not take Edluar with other medicines that make you sleepy. Be sure to tell your doctor if you take:

• antidepressants such as imipramine (Tofranil) and sertraline (Zoloft)
• chlorpromazine (Thorazine)
• antifungal medicines such as itraconazole (Sporanox) and  ketoconazole (Nizoral)
• medications for anxiety
• cold medicines or allergy medicines
• medicines for mental illness
• pain medicines
• medicines for seizures
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers.

This is not a complete list of Edluar drug interactions. Ask your doctor or pharmacist for more information.

Take Edluar exactly as prescribed. Do not take more Edluar than prescribed for you.

• Take Edluar right before you get into bed.
• Only take 1 Edluar tablet a night and only if needed.
• Do not take Edluar if you drank alcohol that evening or before bed.
• You should not take Edluar with or right after a meal. Edluar may help you fall asleep faster if you take it on an empty stomach.
• Do not use the tablet if the seal on the childproof blister pack is broken, or if the blister holding the tablet is broken.
• To open the blister pack, separate the individual blisters at the perforations. Peel off the top layer of paper, and push the tablet through the foil.
• Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.
• 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 problem.

Edluar is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse. Selling or giving away Edluar may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

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.

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.

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.

This section provides information on the proper use of a number of products that contain zolpidem. It may not be specific to Edluar. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take zolpidem just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Zolpidem should not be taken with food or right after a meal. It will work faster if you take it on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are using the oral spray for the first time, it must be primed by spraying it for 5 times in a safe direction away from your face and other people. If the oral spray has not been used for 14 days, it must be primed again with 1 spray.

To use the oral spray:

• Pull the child-resistant cap to separate it from the base.
• Remove the clear protective cap from the pump.
• Hold the container upright with the black spray opening pointed directly into your mouth.
• Fully press down on the pump to make sure that a full dose (5 mg) is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed by your doctor, a second spray should be given.
• Put the clear protective cap back over the pump after each use.

To use the sublingual tablets:

• Do not open the blister pack that contains the tablet until you are ready to take it. Do not use the tablet if the seal of the blister pack is broken.
• Remove the tablet from the blister pack by peeling back the top layer of paper, then push the tablet through the foil.
• Place the tablet under your tongue. It should melt quickly. Do not crush, chew, or swallow the tablet. Do not eat or drink anything after using this medicine.
• If you are taking Intermezzo®, check the time before you take this medicine. Intermezzo® should be taken only if at least 4 hours of sleep remain before the planned time of awakening.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment of insomnia (trouble sleeping):
  • For oral dosage form (oral spray):
    • Adults—10 milligrams (mg) or 2 sprays into the mouth at bedtime.
    • Older adults—5 mg or 1 spray into the mouth at bedtime.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (sublingual tablets):
    • Adults—
      • Edluar®: 5 milligrams (mg) (for women) and 5 or 10 mg (for men) placed under the tongue at bedtime.
      • Intermezzo®: 1.75 mg (for women) and 3.5 mg (for men) placed under the tongue at bedtime.
    • Older adults—
      • Edluar®: 5 mg (for both men and women) placed under the tongue at bedtime.
      • Intermezzo®: 1.75 mg (for both men and women) placed under the tongue at bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use this medicine only when you cannot sleep. You do not need to keep a regular schedule for taking it.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away the oral spray container after 60 sprays have been used.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Zolpidem may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

If you think you need to take zolpidem for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to zolpidem before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. You could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if any of these things occur.

If you will be taking zolpidem for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.

After taking zolpidem for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to breathing problems and unconsciousness. Some signs of an overdose are severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• If you have an allergy to zolpidem or any other part of Edluar (zolpidem sublingual tablets (edluar)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have liver disease.
• If you are taking any other drugs that can make you sleepy. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are taking any of these drugs: Rifampin or St. John's wort.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Edluar with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Take Edluar exactly as prescribed by your doctor. Follow all directions on your prescription label. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Never take this medicine in larger amounts, or for longer than prescribed.

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.

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 this medicine. 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.

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.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

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.

Common side effects of Edluar include: drowsiness. Other side effects include: hallucination, myalgia, visual hallucination, anxiety, and nausea. See below for a comprehensive list of adverse effects.