Versed (Oral)

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

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

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

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

Using this medicine during pregnancy can harm your unborn baby. Use effective birth control to prevent pregnancy. If you think you may be pregnant while using this medicine, inform your doctor immediately.

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 administration. It may also lead to issues with coordination and thinking. Therefore, do not drive, operate machinery, or engage in any activities that may 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 is longer.
• Do not consume alcoholic beverages or take other CNS depressants (medications that slow down the nervous system, potentially causing drowsiness) for about 24 hours after receiving 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 medications; prescription pain medications or narcotics; medications for seizures; and muscle relaxants.

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

Do not take other medications unless you have discussed them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits of the medicine. Consider the following for this medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, such as allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of midazolam in children younger than 6 months. Safety and effectiveness have not been established for this age group.

Geriatric

There have not been appropriate studies on the effects of midazolam in older adults. Safety and effectiveness have not been established for this population.

Breast Feeding

There are no adequate studies in women to determine if there is a risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be taken together, while others can be used together even if an interaction may occur. In cases where both medicines are used, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are significant but not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of your other medicines.

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

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both.

• 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 medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both are prescribed, your doctor may adjust the dose or frequency of use for one or both.

• 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

Some medicines should not be taken around the time of eating or with certain types of food, as interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions are significant, but not necessarily a complete list.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If used together, your doctor may adjust the dose or frequency of this medicine or provide special instructions regarding food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some situations. If used together, your doctor may change the dose or frequency of this medicine or provide specific instructions regarding food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor about any other medical problems you have, especially:

• Apnea (temporary stopping of breathing) or
• Heart disease or
• Hypoventilation (slow breathing) or
• Infections or
• Severe lung disease or
• Lung or airway blockage—Use with caution. This may increase the risk of more serious side effects.

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

• Acute narrow-angle glaucoma—Should not be used in patients with this condition.

Along with its needed effects, Versed (Oral) 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 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 Versed (Oral). 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

• 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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