1 What is Edluar?

Brand: Edluar, Intermezzo, Zolpimist

Generic: Zolpidem

Edluar is used to manage insomnia (sleeping problems). The drug is a central nervous system depressant. The medicine slows down the nervous system. The medicine also gets you to sleep faster and even through the night. In most of the cases, the sleep medicines are used only for short duration of 1 to 2 weeks. This medicine is also only available with the doctor’s prescription.

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2 What to Know Before Using

Before using Edluar, you must know all about the risks and complications associated with it.

There are many other factors that need to be considered such as allergies. In case of allergies, inform your medical doctor. In some cases, when you have had unusual allergic reactions to this medicines or any of the other medicines. You will be required to inform your medical doctor. This is important especially with allergies to food, dyes, preservatives or animals.

When using nonprescription products, always consider reading the label or package of the ingredients before use. Before using this medicines on the pediatrics, check on pediatric studies on the use of this medicines. Appropriate studies have not been performed on the relationship of age to the effects of Zolpidem in the pediatric population. Moreover, safety and efficacy studies of the children have also not been performed.

Similarly, geriatric studies performed to date have not shown geriatric specific problems that limit the use of Zolpidem in the elderly. In case of pregnancy in women, Zolpidem animal studies has shown adverse effects and there are no adequate studies in pregnant women. In addition, no animal studies have been done and there are no adequate studies that have been conducted and the studies conducted to date are not adequate in pregnant women.

In breastfeeding mother, there are no adequate studies in women for determining the infant risk when using this medication while breastfeeding. It is important to weigh the significant potential for risks before using this medication while breastfeeding. As for the drug interactions, some of the medicines may not be used together completely.

In other cases, these medicines may also be used together even with the potential of a significant interactions occurring. In such like cases, the doctor may need to change the dose or other precautions as may be necessary. It is important to let know your doctor when using this medicines. The following interactions have also been selected on the basis of their potential significance and are never inclusive. Use of these medicines is often not recommended. 

However, it may be required in some cases. But when both of the medicines are required in some of the cases, both medicines may be prescribed together. The doctor may change the dose or the frequency with which you take the medicine or both medicines. Some of this medicine includes:

  • Sodium Oxybate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. This medicine include:

  • Alprazolam
  • Bromazepam
  • Buprenorphine Buspirone
  • Butabarbital
  • Carbamazepine
  • Carbinoxamine
  • Ceritinib
  • Chlordiazepoxide
  • Chlorpromazine
  • Clarithromycin
  • Clonazepam
  • Clorazepate
  • Crizotinib
  • Dabrafenib
  • Dexmedetomidine
  • Diazepam
  • Diphenhydramine
  • Doxylamine
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Fentanyl
  • Flibanserin
  • Flumazenil
  • Flurazepam
  • Fospropofol
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Idelalisib
  • Lorazepam
  • Meclizine
  • Meprobamate
  • Methadone
  • Midazolam
  • Morphine
  • Morphine Sulfate Liposome
  • Nilotinib
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Piperaquine
  • Prazepam
  • Promethazine
  • Propofol
  • Quazepam
  • Ramelteon
  • Secobarbital
  • Suvorexant
  • Tapentadol
  • Temazepam
  • Thioridazine
  • Triazolam
  • Zaleplon

Using this medicine with any of the following medicines may cause an increased risk of certain side effects. Using both drugs may be the best treatment for you in some cases.  In case both of the medicines are prescribed together, your doctor may change the dose or how frequent the medicine may be used when the medicines are prescribed together. The medicines include:

  • Bupropion
  • Ciprofloxacin
  • Desipramine
  • Fluvoxamine
  • Ketoconazole
  • Rifampin
  • Sertraline
  • St John's Wort
  • Telaprevir
  • Venlafaxine

Other Interactions may occur when the medicines are used at or around the times of using food. Moreover, using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions listed above are listed on the basis of their potential significance and are not necessarily all-inclusive. It is also known that use of this medicine may cause an increased risk of certain side effects and can be unavoidable in some cases.

When the medicines are used together, the doctor may vary the dose or how often you use the medicine or offer you special instructions on how the food can be used, alcohol or tobacco. The presence of the medical problems may affect the use of these medicines.

Inform your medical doctor when suffering from other medical problems. This may be in the form of alcohol abuse, history of or drug abuse or dependence, history of dependence on zolpidem may develop. Depression, history of or Lung disease or other breathing problems or Mental illness, history of or Myasthenia gravis (muscle disease) or Sleep apnea (breathing problems during sleep). Use these medicines with a caution since they may make these conditions worse is cases such as in liver disease. The effects of the medicines may also be increased because of slower removal of the medicine from the body.

3 Proper Usage

Edluar must be used only as instructed by your medical doctor. Never take more or less of the medicine. Similarly, do not take the medicine more often than it is required. In addition, do not use too much of the medicine. It may become a habit forming or causing more of mental or physical dependence. The medicine needs to come with the medication guide.

It is important to read and follow the instructions of the medicines carefully. Ask your doctor if you have any of the questions. Take the medicine only before going to bed and when you feel you are ready to go to sleep. It is known that this medicine works very fast in putting you to sleep.  Never take this medicine when you anticipate a busy schedule that will not permit you to get a full time sleep for about 7-8 hours.

In case you need to wake up before the 8 hours are elapsed, note that you will be feeling drowsy and may experience problems with memory since the effects of the medicine does not have time to wear off. Moreover, Zolpidem also need not be taken with food or right after the meals. It is known to work faster when taken on an empty stomach. But when advised by your doctor to take the medicine as instructed, take it as directed by your doctor.

When using the oral spray for the first time, it needs to be primed by spraying it for about 5 times in a safe direction away from your face and other people. In case the oral spray has not been used for a duration of 14 days, it must be primed again with a single spray.

In order to use the oral spray, pull the child resistant cap so as to separate it from the base. Remove the clear protective pad from the pump. Hold the container in an upright position with the black spray opening pointed directly into your mouth. Press down the pump fully to make the full dose of 5 mgs directly into your mouth over the tongue. When a 10 mg dose is to be administered by your doctor, a second spray must be given. Put the clear protective cover back over the pump each time after use.

If you are to use a sublingual tablet: you must not open the blister pack that contains the tablets until when you are ready to take the medicine. Never use the tablet when the seal has been tampered with or broken. Remove the tablet from the blister pack by peeling back the top later of the paper and then push back the tablet through the foil. Place the tablet under the tongue. It should be able to melt very fast. Never chew or crush or swallow the tablet.

Do not eat or drink anything after using the medicine.  When using Intermezzo, check the time before you take the medicine. Intermezzo can only be used when at least 4 hours of sleep remain before the planned time of awakening. The dose of this medicine is always different for different patients. Always stick to your doctor’s instructions and directions. The information provided in this article is only for guidance.  When the dose of the medicine you are using is different, do not change the dose unless your doctor tells you to change to a new dose.

Moreover, the amount of medicine that you take is also always different from the doses you take each day, time allowed between each of the doses, length of time you take the medicine also depends on the medical problem for which you will be using the medicine. For treatment of Insomnia using an oral dosage form of an oral spray: Adults needs a dose of 10 mg or 2 sprays into the mouth before bed time. In the case of older adults, a dose of 5 mg or 1 spray is needed into the mouth at bedtime.

In children, the use and dose of the medicine depends on the dose that is determined by your doctor. When using the oral dose for subligual tablets: adults use 5 milligrams for women and 5 or 10 milligrams for men placed under the tongue at bed time. Intermezzo 1.75 mg for women and 3.5 mg for men placed under the tongue at bed time. Older adults using Edluar 5 mg for both men and women placed under the tounge at bed time. Intermezzo 1.75 mg for both men and women when placed under the tongue at bed time.

The use of this medicine by children and dose is determined by the doctor. In case of missed doses, the missed dose should be skipped and go back to the regular dosing schedule. Never take double doses. Use this medicine only when you cannot sleep. You do not need to keep a regular schedule for taking the medicine. Store the medicines in a closed container at room temperature and away from heat, moisture and direct light. Keep the medicines from freezing and away from the reach of children. Never store outdated medicine or medicine that is no longer needed by you. Consult your healthcare professional how this medicine can be disposed. Throw away the oral spray container after 60 sprays have been used.

4 Precautions to Take

In using Edluar, you must be careful and take some precautions as advised by your doctor.

Regular medical checkups are important so as to evaluate the progress on the use of medicine and to evaluate on the unwanted effects with the use of this medicine. Zolpidem may cause serious allergic reactions such as anaphylaxis which are mainly life threatening and may need immediate medical attention. Inform your medical doctor if you have a rash, itching, hives, hoarseness, trouble breathing, or swallowing or any swelling of your hands or face, mouth or threat while using this medicine.

If you think you need to use zolpidem for more than 7 or 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 adds to the effects of alcohol and other CNS depressant. Examples of CNS depressants include: 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. Always consult your doctor before you start using any of the above medicines.

Sometimes, these medicines cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or fewer alerts than they are normally. Even after it has been taken at bed time, it may cause some people to feel drowsy or less alert on arising. It is also suggested that it can cause double vision or other vision problems.

Always remember to understand how your react to zolpidem before you drive, use machines, or do anything else that may pose great threat and danger to your life. These are especially when you become dizzy, or are not alert or able to see well. In case of developing unusual and strange thoughts or behavior after taking zolpidem, be sure to discuss it with your doctor.

Some changes that have been observed in people that use zolpidem are similar to those that drink alcohol and then act as if ad if they are not normal. Some of the other changes are unusual and extreme and may present as confusion, worsening of depression, hallucinations, suicidal thoughts, and unusual excitements, nervousness, or irritability. You also find yourself doing things while asleep that you may not remember the next day. One can also drive a car, sleep walk, have sex, make phone calls, prepare and eat food while sleeping or not fully awake.

In case of such like occurrences, inform your medical doctor right away. If you will use zolpidem for a longer duration, do not stop taking the medicine without first checking with your doctor. The doctor may also want you to gradually reduce the dose before you stop using the medicine. If stopped suddenly, the medicine may cause withdrawal side effects. Even after using zolpidem for control of insomnia, you still may have some difficulty sleeping also referred to as rebound insomnia for a few nights after you have stopped using the medicine.

When you think you or someone else may have used an overdose of the medicine, seek emergency help immediately. Taking an overdose of the medicine or taking alcohol or other CNS medicines with zolpidem may cause problems with breathing and unconsciousness. Some of the signs of overdose include severe drowsiness, severe nausea, vomiting, staggering and troubled breathing. Never take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription medicines and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Edluar.

It is known that not all of the listed side effects will occur. However, when they occur, medical attention will be required. It is important to check with your doctor when any of the following side effects occur:

The less common side effects include:

  • Clumsiness or Unsteadiness
  • Confusion
  • Depression

Some of the side effects occurs rarely:

  • Difficulty with breathing
  • Dizziness, Lightheadedness, or Fainting falling
  • Fast heartbeat
  • Seeing, Hearing, or Feeling things that are not there
  • Skin rash
  • Swelling of the face
  • Trouble sleeping
  • Unusual excitement
  • Nervousness, or irritability
  • Wheezing

It is also indicated that some of the side effects may occur and go away during treatments as your body gets used to the medicine. It is advisable to consult your medical doctor. The doctor may be able to advice you of better ways to prevent or reduce some of the side effects. In addition, always check with your medical doctor if some of the side effects continue or become bothersome or just to address any of your pressing questions.

Common side effects include:

  • Sleepiness
  • Unusual drowsiness

Less common symptoms include:

  • Abdominal or Stomach pain
  • Abnormal or Decreased touch sensation
  • Abnormal sensation of movement
  • Appetite disorder
  • Balance disorder
  • Binge eating
  • Bloody or Cloudy urine
  • Blurred vision
  • Burning, Crawling, Itching, Numbness, Prickling, "Pins and Needles", or Tingling feelings
  • Change in hearing
  • Chest discomfort
  • Chills
  • Confusion about identity, place, and time
  • Constipation
  • Continuous ringing, buzzing, or other unexplained noise in the ears daytime
  • Drowsiness
  • Diarrhea
  • Difficult, Burning, or Painful urination
  • Difficulty with moving
  • Difficulty with swallowing
  • Discouragement
  • Double vision
  • Drugged feeling
  • Dry mouth
  • Ear ache
  • Eye redness
  • False or Unusual sense of well-being
  • Feeling of unreality
  • Feeling sad or empty frequent bowel movements
  • Frequent urge to urinate
  • Headache
  • Hearing loss
  • Heartburn
  • Hives or Welts
  • Itching ears
  • Joint pain
  • Lack of appetite
  • Lack of feeling or emotion
  • Lack or Loss of self-control
  • Lack or Loss of strength
  • Longer or Heavier, menstrual periods
  • Loss of balance
  • Loss of interest or pleasure
  • Memory problems
  • Mood swings
  • Muscle aches, cramping, pain, or stiffness
  • Nausea
  • Nightmares or Unusual dreams
  • Redness of the skin
  • Redness or Soreness of the throat
  • Sense of detachment from self or body
  • Slowing of mental and physical activity
  • Sneezing
  • Stuffy or Runny nose swollen joints
  • Tiredness
  • Trouble concentrating
  • Vision changes
  • Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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