Remimazolam

Remimazolam is a prescription medication used for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

• Remimazolam is available under the following different brand names: Byfavo

Common side effects of Remimazolam include:

• lightheadedness,
• shallow breathing, and
• changes in blood pressure

Serious side effects of Remimazolam include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• weak or shallow breathing,
• confusion,
• slow heartbeats,
• lightheadedness,
• drowsiness, and
• dizziness

Rare side effects of Remimazolam include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Lyophilized powder for reconstitution

• 20 mg/vial

Procedural Sedation

Adult dosage

• Induction
  • 5 mg IV push over 1 minute
  • ASA-PS III/IV patients: 2.5-5 mg IV push over 1 minute based on the patient’s general condition
• Maintenance
  • 2.5 mg IV push over 15 seconds
  • ASA-PS III/IV patients: 1.25-2.5 mg IV push over 15 seconds; at least 2 minutes must elapse before administration of any supplemental dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Remimazolam has severe interactions with no other drugs.
• Remimazolam has serious interactions with the following drug:
  • olopatadine intranasal
• Remimazolam has moderate interactions with at least 135 other drugs.
• Remimazolam has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Severe hypersensitivity reaction to dextran 40

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Remimazolam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Remimazolam?”

Cautions

• Clinically notable hypoxia, bradycardia, and hypotension observed in clinical trials; continuously monitor vital signs during sedation and through the recovery period
• Contains dextran 40, which can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis
• Benzodiazepine use in late-stage pregnancy can result in sedation in the neonate; observe newborns for signs or sedation and manage accordingly
• Pediatric neurotoxicity
  • Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increases neuronal apoptosis in the developing brain and results in long-term cognitive deficits when used for longer than 3 hr
  • Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects
• Drug interaction overview
  • Coadministration with opioid analgesics may result in profound sedation, respiratory depression, coma, and death
  • Sedative effect of remimazolam can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol
  • Titrate dose when administered with opioid analgesics and sedative-hypnotics to desired clinical response
  • Continuously monitor sedated patients for hypotension, airway obstruction, hypoventilation, apnea, and oxygen desaturation; these cardiorespiratory effects may be more likely to occur in patients with obstructive sleep apnea, geriatric patients, or ASA-PS III or IV patients

Pregnancy and Lactation

• Benzodiazepines cross the placenta; receiving benzodiazepines late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate
• Therapy may produce respiratory depression, hypotonia, and sedation in neonates; monitor neonates exposed to therapy during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems; monitor neonates exposed to this drug during pregnancy for signs of withdrawal; manage these neonates accordingly
• Published observational studies of pregnant women exposed to benzodiazepines have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinical considerations
  • Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates
  • Monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation and respiratory depression and manage accordingly
• Lactation
  • There are reports of sedation, poor feeding, and poor weight gain in infants exposed to benzodiazepines through breast milk; there are no data on the effects of this drug in human milk, effects on the breastfed infant or milk production
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from this drug or an underlying maternal condition
  • Remimazolam is present in animal milk; when a drug is present in animal milk, it will likely be present in human milk
  • Infants exposed to the drug through breast milk should be monitored for sedation, poor feeding, and poor weight gain