Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Neurology | Pediatrics/Neonatology
View By:YearCompanyConditionsTherapeutic AreasDrug Names
VERSED (midazolam HCI)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved March 1997
Treatment Area: sedative for children undergoing painful surgeries
VERSED (midazolam HCI), can be used to calm and sedate children
who must undergo procedures such as bone-marrow aspiration or
spinal tap. Sedating a child also may spare parents the trauma of
watching their child being physically restrained during procedures.
Without sedation, such restraint is often necessary, and parents
may even participate in restraining their child, which can be very
distressing. VERSED also can be used to help calm children facing
surgery, who might otherwise be terrified by the mask used to
administer anesthesia, or by separation from their parents.
VERSED now is also available for use in infants and children of
all ages in critical care settings. (This is the first time a
sedative has been approved for use of any kind in newborns.)
Without sedation, babies and children may have a difficult time
tolerating a breathing tube or ventilator - and fighting a
ventilator can be life-threatening.
After sedation with VERSED, a child usually has little or no
memory of undergoing the procedure. This "amnestic"
quality of VERSED is particularly advantageous because without it,
children sometimes suffer from nightmares or other psychological
traumas after undergoing medical procedures.
VERSED is an injectable sedative that has a variety of uses,
depending on its dosage and administration. It can be used as a
light sedative to help alleviate a child’s anxiety before a
therapeutic or diagnostic procedure, as well as to allow the child
to forget what happened during the period of sedation; as a mild to
moderate sedative to cause a deeper state of sedation; and as a
part of general anesthesia during surgery. Intravenous VERSED also
can be administered by continuous infusion to children in critical
In seriously ill neonates, the half-life of midazolam is
substantially prolonged and the clearance reduced compared to
healthy adults or older groups of children. Exposure to excessive
amounts of benzyl alcohol has been associated with toxicity,
particularly in neonates and preterm infants. The recommended
dosage range of VERSED for preterm and term infants includes the
amount of benzyl alcohol well below that associated with toxicity;
however, the amount of benzyl alcohol at with toxicity may occur is
not known. Intravenous bolus doses should not be used in neonates;
if given as a loading dose, VERSED should be infused over ten
Hypotension may be observed in patients who are critically ill,
and in preterm and term infants, particularly those receiving
opioids and/or when VERSED is administered rapidly. When VERSED is
given in conjunction with opioids or other sedatives, the potential
for respiratory depression/airway obstruction is increased and the
minimum effective dose of VERSED is generally reduced.