Midazolam (Oral)

Midazolam helps make you sleepy or drowsy and reduces anxiety before surgery or some procedures. It is also given to cause amnesia (loss of memory) so you will not remember any discomfort or unpleasant effects that may happen after a surgery or procedure.

Midazolam is a benzodiazepine. Benzodiazepines are a type of medicine known as central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is given only by a doctor or under the close supervision of a doctor trained to use it.

If you will be receiving midazolam before surgery, your doctor will give you the medicine and watch you closely to make sure it is working properly and to check for any side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to avoid getting pregnant. If you think you might be pregnant while using this medicine, tell your doctor right away.

For patients going home within 24 hours after receiving midazolam:

• Midazolam may cause some people to feel drowsy, tired, or weak for 1 or 2 days after it has been given. It may also affect coordination and thinking ability. Therefore, do not drive, use machines, or do anything else that could be dangerous if you are not alert until the effects of the medicine have worn off or until the day after you receive midazolam, whichever period of time is longer.
• Do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system and may cause drowsiness) for about 24 hours after you have received midazolam, unless your doctor tells you otherwise. Doing so may increase the effects of the medicine. Some examples of CNS depressants include antihistamines or medicines for hay fever, other allergies, or colds; other sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; medicines for seizures; and muscle relaxants.

Do not drink grapefruit juice or eat grapefruit while you are using this medicine. Also, do not take this medicine if you are allergic to cherries.

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

In deciding to use a medication, the risks of taking the medication must be weighed against the good it will do. This is a decision you and your clinician will make. For this drug, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other drugs. Also inform 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 midazolam in children below 6 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of midazolam in the geriatric population. Safety and efficacy have not been established.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this drug while breastfeeding.

Interactions with Medications

Although certain drugs should not be used together at all, in other cases two different medications 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 receiving this drug, it is especially important that your healthcare professional know if you are taking any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following drugs is not recommended. Your doctor may decide not to treat you with this drug or change some of the other medications you take.

• Amprenavir
• Atazanavir
• Boceprevir
• Cobicistat
• Darunavir
• Delavirdine
• Flumazenil
• Fosamprenavir
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Nelfinavir
• Nirmatrelvir
• Ritonavir
• Saquinavir
• Telaprevir
• Tipranavir

Using this drug with any of the following medicines is usually not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Aripiprazole
• Baclofen
• Belzutifan
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Conivaptan
• Cyclobenzaprine
• Dabrafenib
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Dezocine
• Diacetylmorphine
• Diazepam
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Dronedarone
• Duvelisib
• Elagolix
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethylmorphine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Flunitrazepam
• Flurazepam
• Fosnetupitant
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Idelalisib
• Imatinib
• Isavuconazonium Sulfate
• Ivacaftor
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levorphanol
• Lofexidine
• Lorazepam
• Lorlatinib
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Metoclopramide
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Netupitant
• Nicomorphine
• Nilotinib
• Nitrazepam
• Olutasidenib
• Omaveloxolone
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Pacritinib
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Periciazine
• Phenobarbital
• Piritramide
• Pirtobrutinib
• Posaconazole
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Promethazine
• Propofol
• Quazepam
• Ramelteon
• Remifentanil
• Remimazolam
• Ribociclib
• Ritlecitinib
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Simeprevir
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Thioridazine
• Tilidine
• Tizanidine
• Tocilizumab
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trofinetide
• Zaleplon
• Zolpidem
• Zopiclone
• Zuranolone

Using this drug with any of the following medicines may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your physician may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Armodafinil
• Carbamazepine
• Cimetidine
• Crizotinib
• Cyclosporine
• Dalfopristin
• Diltiazem
• Echinacea
• Erythromycin
• Fluvoxamine
• Fosaprepitant
• Fosphenytoin
• Ginkgo Biloba
• Goldenseal
• Halothane
• Laropiprant
• Mitotane
• Phenytoin
• Quinupristin
• Rifapentine
• Roxithromycin
• St John's Wort
• Telithromycin
• Theophylline
• Verapamil
• Voriconazole

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 drug with any of the following is normally not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this drug with any of the following may cause an increased chance of certain adverse effects but may be unavoidable in some cases. If used together, your physician may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical issues may affect the use of this medicine. Make sure you tell your clinician if you have any other medical issues, especially:

• Apnea (short-lived discontinuing of breathing) or
• Heart disease or
• Hypoventilation (slow breathing) or
• Infections or
• Lung disease, severe or
• Lung or airway blockage—Use with caution. May increase chances for more serious adverse effects.

• Congestive heart failure or
• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

• Glaucoma, acute narrow-angle—Should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Anxiety
• chest pain or discomfort
• choking
• confusion
• difficult or troubled breathing
• drowsiness
• dry mouth
• fast heartbeat
• hyperventilation
• irregular heartbeats
• irregular, fast or slow, or shallow breathing
• irritability
• lightheadedness, dizziness, or fainting
• nausea
• nervousness
• noisy breathing
• pale or blue lips, fingernails, or skin
• restlessness
• shaking
• shortness of breath
• slow or irregular heartbeat
• tightness in the chest
• trouble sleeping
• unable to speak
• unusual tiredness
• weakness
• wheezing

Rare

• Attack, assault, or force
• changes in patterns and rhythms of speech
• feeling of constant movement of self or surroundings
• headache
• lack or loss of self-control
• loss of balance
• mood swings
• noisy breathing
• not breathing
• restlessness
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• shakiness and unsteady walk
• sleepiness
• slow to respond
• slurred speech
• trouble in speaking
• unconsciousness
• unsteadiness, trembling, or other problems with muscle control or coordination

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• difficulty with coordination
• loss of consciousness
• sleepiness or unusual drowsiness

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. 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

• Vomiting

Less common

• Rash

Rare

• Blurred vision
• double vision
• gagging
• hiccups
• seeing double
• watering of mouth and drooling

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.

In the U.S.

• Versed

Available Dosage Forms:

• Syrup

Therapeutic Class: Anesthetic Adjunct

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Midazolam will be given to you or to your child in a hospital or clinic by a doctor trained to use this medicine. If you or your child will be receiving midazolam during surgery, your doctor or anesthesiologist will give you the medicine.

After you receive midazolam, you or your child will be watched closely to make sure this medicine is working. Your breathing, blood pressure, nervous system, and heart will also be watched closely to make sure the medicine is not causing unwanted side effects.

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