Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome

Title: Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome

Kraft, W.K. et al.


What You Need to Know:

In infants with the neonatal abstinence syndrome, sublingual buprenorphine reduced the duration of treatment, decreased the length of hospital stay, and had a similar rate of adverse events when compared to oral morphine.

Trial Design:

  • Double-blind, double-dummy study compared sublingual buprenorphine to oral morphine in the treatment of neonatal abstinence syndrome
  • 63 infants (37 weeks gestation) who were exposed to opioids during pregnancy and displayed signs of the neonatal syndrome were randomized to receive buprenorphine or morphine
  • Adjunctive phenobarbital was utilized in infants with uncontrolled symptoms despite receiving the maximum dose of opioid
  • Primary endpoint: “duration of treatment for symptoms of neonatal opioid withdrawal”
  • Secondary endpoints: hospital stay length, percent of infants requiring adjunctive phenobarbital treatment, safety

Key Outcomes:

  • Shorter median duration of treatment observed in buprenorphine patients vs morphine patients (15 days vs 28 days, respectively; P<0.001)
  • Median length of hospital stay was 21 days for buprenorphine patients vs 33 days for morphine patients (P<0.001)
  • 15% of buprenorphine patients (5/33) received adjunctive phenobarbital vs 23% of morphine patients (7/30) (P=0.36)
  • Similar rates of adverse events observed between the two groups