Remimazolam

Remimazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that helps you relax before minor surgery, dental work, or other medical procedures.

Remimazolam may also be used for reasons not mentioned in this medication guide.

Remimazolam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that slow your breathing.

You should not be treated with remimazolam if you are allergic to remimazolam or dextran 40.

Remimazolam may harm an unborn baby and is generally not recommended during pregnancy. Inform your doctor if you are pregnant.

If you use remimazolam during pregnancy, your baby could be born with serious sedation or withdrawal symptoms and may require medical treatment for several weeks.

Anesthesia may impact brain development in a young child or unborn baby (when used in the mother), which may lead to learning or behavior problems later in life. Longer surgeries or repeated procedures carry the highest risks.

Anesthesia may still be necessary for a life-threatening condition, medical emergency, or surgery to fix a birth defect. Your doctor can provide information about all medicines used during a surgery or procedure.

If you are breastfeeding, inform your doctor if you notice sedation, poor feeding, or poor weight gain in the nursing baby.

Do not breastfeed within 5 hours after using remimazolam. If you use a breast pump during this time, discard the milk and do not feed it to your baby. Inform your doctor if you are breastfeeding or planning to breastfeed.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remimazolam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. Your caregivers will monitor you for symptoms such as weak or shallow breathing.

Tell your medical caregivers right away if you have:

• weak or shallow breathing;
• confusion;
• slow heartbeats; or
• a light-headed feeling, like you might pass out.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of remimazolam may include:

• feeling light-headed;
• shallow breathing; or
• changes in blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Midazolam is injected into a vein by a healthcare provider.

Remimazolam is usually given as a single dose just before a surgery or medical procedure.

Remimazolam can make you very drowsy, dizzy, or light-headed. These effects may last longer in older adults. Use caution to avoid falling or accidental injury after you have received remimazolam. You may need help getting out of bed for several hours.

You will be watched to make sure the medication is working and does not cause harmful side effects.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

In a medical setting, you are unlikely to miss a dose.

In a medical setting, an overdose would be treated quickly.

Do not drink alcohol shortly after receiving remimazolam.

Remimazolam can cause extreme drowsiness that may last for several hours after you have received the medication. Older adults may feel sleepy for even longer.

Avoid driving or doing anything that requires you to be awake and alert until the effects of remimazolam have worn off completely.

Shortly after you receive remimazolam, using other medications that make you sleepy or slow your breathing can lead to serious side effects or death. Ask your doctor before taking opioid medicine, a sleeping pill, a muscle relaxer, or medication for anxiety or seizures.

Other medications may interact with remimazolam, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.