Zolpidem (Oromucosal, Sublingual)

Generic name: Zolpidem
Drug class: Miscellaneous anxiolytics , Antineoplastic Agents

Usage of Zolpidem (Oromucosal, Sublingual)

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 throughout 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.

Zolpidem (Oromucosal, Sublingual) side effects

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:

Less common

Clumsiness or unsteadiness

confusion about identity, place, and time

discouragement

drugged feeling

false or unusual sense of well-being

feeling of unreality

feeling sad or empty

hives or welts

irritability

lack of appetite

lack of feeling or emotion

loss of interest or pleasure

lack or loss of self-control

memory problems

mood swings

nightmares or unusual dreams

sense of detachment from self or body

slowing of mental and physical activity

tiredness

trouble concentrating

trouble sleeping

Rare

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

unusual excitement, nervousness, or irritability

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:

More common

Sleepiness or unusual drowsiness

Less common

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

chills

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

double vision

dry mouth

earache

eye redness

frequent bowel movements

frequent urge to urinate

headache

hearing loss

heartburn

itching ears

joint pain

lack of appetite

lack or loss of strength

longer or heavier menstrual periods

loss of balance

muscle aches, cramping, pain, or stiffness

nausea

redness of the skin

redness or soreness of the throat

sneezing

stomach pain

stuffy or runny nose

swollen joints

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.

Before taking Zolpidem (Oromucosal, Sublingual)

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:

Allergies

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.

Pediatric

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.

Geriatric

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.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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.

Calcium Oxybate

Magnesium Oxybate

Potassium Oxybate

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.

Abametapir

Acepromazine

Alfentanil

Alprazolam

Amiodarone

Amobarbital

Amprenavir

Anileridine

Apalutamide

Aprepitant

Aripiprazole

Aripiprazole Lauroxil

Armodafinil

Asenapine

Atazanavir

Baclofen

Benperidol

Benzhydrocodone

Boceprevir

Bosentan

Bromazepam

Bromopride

Buprenorphine

Buspirone

Butabarbital

Butorphanol

Cannabis

Carphenazine

Cenobamate

Ceritinib

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Cimetidine

Ciprofloxacin

Clarithromycin

Clobazam

Clofazimine

Clonazepam

Clorazepate

Clozapine

Cobicistat

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Dabrafenib

Daridorexant

Darunavir

Delavirdine

Dexamethasone

Dexmedetomidine

Diacetylmorphine

Diazepam

Dichloralphenazone

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dipyrone

Doxylamine

Dronedarone

Droperidol

Duvelisib

Efavirenz

Elagolix

Enflurane

Enzalutamide

Erythromycin

Esketamine

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etravirine

Fedratinib

Fentanyl

Fexinidazole

Flibanserin

Fluconazole

Flumazenil

Flunitrazepam

Fluphenazine

Flurazepam

Fluspirilene

Fluvoxamine

Fosamprenavir

Fosaprepitant

Fosnetupitant

Fosphenytoin

Fospropofol

Gabapentin

Gabapentin Enacarbil

Halazepam

Haloperidol

Halothane

Hexobarbital

Hydrocodone

Hydromorphone

Hydroxyzine

Idelalisib

Imatinib

Imipramine

Indinavir

Isoflurane

Itraconazole

Ivacaftor

Ivosidenib

Josamycin

Ketamine

Ketazolam

Ketobemidone

Ketoconazole

Lacosamide

Larotrectinib

Lemborexant

Lesinurad

Letermovir

Levocetirizine

Levoketoconazole

Levorphanol

Lofexidine

Lomitapide

Lonafarnib

Lopinavir

Lorazepam

Lorlatinib

Loxapine

Lumacaftor

Mavacamten

Meclizine

Melperone

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methdilazine

Methocarbamol

Methohexital

Methotrexate

Methotrimeprazine

Methylene Blue

Metoclopramide

Mibefradil

Midazolam

Mifepristone

Mitotane

Modafinil

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Nefazodone

Nelfinavir

Netupitant

Nevirapine

Nicomorphine

Nilotinib

Nitrazepam

Nitrous Oxide

Olanzapine

Omaveloxolone

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Palbociclib

Papaveretum

Paregoric

Pentazocine

Pentobarbital

Perazine

Periciazine

Perphenazine

Phenobarbital

Phenytoin

Pimozide

Piperacetazine

Pipotiazine

Piritramide

Posaconazole

Prazepam

Prednisone

Pregabalin

Primidone

Prochlorperazine

Promazine

Promethazine

Propofol

Quazepam

Quetiapine

Ramelteon

Ranitidine

Ranolazine

Remifentanil

Remimazolam

Remoxipride

Ribociclib

Rifabutin

Rifampin

Rifapentine

Ritonavir

Ropeginterferon Alfa-2b-njft

Saquinavir

Schisandra sphenanthera

Scopolamine

Secobarbital

Sertindole

Sertraline

St John's Wort

Sufentanil

Sulpiride

Tapentadol

Telaprevir

Telithromycin

Telotristat Ethyl

Temazepam

Thiethylperazine

Thiopental

Thiopropazate

Thioridazine

Tilidine

Tizanidine

Tolonium Chloride

Topiramate

Tramadol

Trazodone

Treosulfan

Triazolam

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Troleandomycin

Tucatinib

Verapamil

Voriconazole

Voxelotor

Zaleplon

Zopiclone

Zotepine

Zuranolone

Interactions with Food/Tobacco/Alcohol

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.

Ethanol

Relate drugs

How to use Zolpidem (Oromucosal, Sublingual)

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.

Do not take this medicine if you have drank alcohol the same evening or just before bedtime.

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 milligrams [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 once a day, at bedtime. Your doctor may increase your dose as needed. However, do not take more than 10 mg per day.

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 is not recommended.

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.

Warnings

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 and angioedema, which can be life-threatening and require 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.

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 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, which may lead to falls, fractures, or other injuries. 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you develop any unusual and strange thoughts or behavior while you are using zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people using 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.

Using this medicine during the last 3 months of pregnancy can harm your newborn baby. Check with your doctor right away if your baby has pale or blue lips, fingernails, or skin, difficult or troubled breathing, excessive sleepiness, or limpness. Tell your doctor right away if you are pregnant or if you think you have become pregnant while using this medicine.

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

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

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 include 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.

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