Remimazolam (rem-i-MAZ-oh-lam)

Helps you relax or sleep before and during medical procedures lasting 30 minutes or less. This medicine is an anesthetic and a sedative.

Brand Name(s):

Byfavo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how remimazolam works. Tell your doctor if you are using propofol.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later part of a pregnancy may cause problems in your newborn baby (including sedation or withdrawal symptoms). Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding or planning to breastfeed. This medicine passes into your breast milk and may cause problems in your baby. Talk to your doctor about the best way to feed your baby.
• Tell your doctor if you have liver disease, heart disease, lung or breathing problems, or sleep apnea.
• This medicine may cause the following problems:
  • Increased risk of overdose, which can be life-threatening
  • Heart or lung problems, including low blood pressure, especially when used with certain medicines
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips, fingernails, or skin, trouble breathing, chest pain
• Change or loss of consciousness, dizziness, faintness, lightheadedness, problems with coordination or walking, unusual drowsiness
• Fast, slow, or uneven heartbeat, cold sweat, bluish-colored skin
• Severe drowsiness, slow, shallow breathing
• Unusual tiredness or weakness, muscle pain or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea
• Pain, redness, or swelling where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088