Zolpidem (Oromucosal route, sublingual route)
Uses of This Medicine:
Zolpidem is used to treat insomnia (sleeping problems). It belongs to the group of medicines called central nervous system (CNS) depressants. These medicines will slow down the nervous system. Zolpidem will help you get to sleep faster and sleep through the night. In most cases, sleep medicines should only be used for short periods of time, such as 1 or 2 days, and for no longer than 1 or 2 weeks.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of zolpidem in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolpidem in the elderly. However, confusion, dizziness, and falling are more likely to occur in the elderly, who are more sensitive than younger adults to the effects of zolpidem.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- 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.
- Chloral Hydrate
- Morphine Sulfate Liposome
- Opium Alkaloids
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- 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 with caution. May make these conditions worse.
- Liver disease Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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.
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):
- 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.
- For oral dosage form (oral spray):
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.
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.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- Less common
- Clumsiness or unsteadiness
- Difficulty with breathing
- dizziness, lightheadedness, or fainting
- fast heartbeat
- seeing, hearing, or feeling things that are not there
- skin rash
- swelling of the face
- trouble sleeping
- unusual excitement, nervousness, or irritability
- More common
- Sleepiness or unusual drowsiness
- Less common
- Abdominal or stomach pain
- abnormal or decreased touch sensation
- abnormal sensation of movement
- appetite disorder
- balance disorder
- binge eating
- bladder pain
- bloody or cloudy urine
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in hearing
- chest discomfort
- confusion about identity, place, and time
- continuous ringing, buzzing, or other unexplained noise in the ears
- daytime drowsiness
- difficult, burning, or painful urination
- difficulty with moving
- difficulty with swallowing
- double vision
- drugged feeling
- dry mouth
- eye redness
- false or unusual sense of well-being
- feeling of unreality
- feeling sad or empty
- frequent bowel movements
- frequent urge to urinate
- hearing loss
- 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
- 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
- stuffy or runny nose
- swollen joints
- trouble concentrating
- vision changes
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
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.
Last Updated: 10/12/2016