What are the considerations for postpartum women using Suboxone (buprenorphine/naloxone)?

From the Guidelines

Postpartum women using Suboxone (buprenorphine/naloxone) should continue their medication as prescribed, with careful monitoring and management of potential interactions and side effects.

Key Considerations

• Continuation of buprenorphine: The feasibility of continuing buprenorphine during the postpartum year should be established during pregnancy, and plans should be made to support this treatment choice 1.
• Dosing and monitoring: The daily dosage of buprenorphine may need to be adjusted during pregnancy, with higher and more frequent doses (2-4 times daily) potentially required, increasing with increasing gestational age 1.
• Pain management: Postpartum pain after vaginal delivery should be managed with a multimodal approach, and additional systemic opioids may be necessary after delivery, but these medications should not be ordered routinely 1.
• Potential interactions: Careful medication management is recommended for women concurrently using benzodiazepines or other central nervous system depressants with buprenorphine 1.

Important Details

• Buprenorphine monotherapy vs combination therapy: Although data about the safety of buprenorphine plus naloxone or buprenorphine alone during pregnancy are limited, they do not support the theoretic concern of precipitated withdrawal with the naloxone component 1.
• Counseling and support: Patients who receive buprenorphine should attend at least monthly counseling sessions, but fulfilling this recommendation can be challenging due to significant gaps between OUD treatment needs and available capacity in the United States 1.

From the FDA Drug Label

Clinical Considerations Fetal/neonatal adverse reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight. Signs of neonatal withdrawal usually occur in the first days after birth. The duration and severity of neonatal opioid withdrawal syndrome may vary Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS: Neonatal Opioid Withdrawal Syndrome]. Labor and Delivery The safety of buprenorphine hydrochloride given during labor and delivery has not been established. As with all opioids, use of buprenorphine prior to delivery may result in respiratory depression in the newborn Closely monitor neonates for signs of respiratory depression. An opioid antagonist such as naloxone should be available for reversal of opioid induced respiratory depression in the neonate.

The considerations for postpartum women using Suboxone (buprenorphine/naloxone) include:

• Neonatal Opioid Withdrawal Syndrome: Monitor newborns for signs of withdrawal, such as irritability, hyperactivity, and abnormal sleep patterns.
• Respiratory Depression: Closely monitor neonates for signs of respiratory depression, and have an opioid antagonist like naloxone available for reversal.
• Lactation: Breast-feeding is not advised in nursing mothers treated with buprenorphine hydrochloride, as buprenorphine passes into the mother's milk 2. It is essential to weigh the benefits and risks of using buprenorphine in postpartum women, considering the potential for neonatal opioid withdrawal syndrome and respiratory depression. 2 2

From the Research

Considerations for Postpartum Women Using Suboxone (Buprenorphine/Naloxone)

• The use of buprenorphine combined with naloxone during pregnancy appears to be a safe treatment option for opioid use disorder, with similar or more favorable neonatal and maternal outcomes compared to buprenorphine alone 3.
• Buprenorphine maintenance treatment is effective in decreasing the risk of relapse in pregnant women and may decrease the severity and duration of neonatal abstinence syndrome compared to methadone maintenance 4.
• Only small amounts of buprenorphine enter breast milk, making it a good option for postpartum women who elect to breast-feed 4.
• Management of buprenorphine includes initiation and maintenance treatment, as well as careful planning for pain control during and after delivery and prevention of postpartum relapse risk 4.
• Buprenorphine-naloxone seems to be as safe for pharmacotherapy for maternal opioid use disorder as buprenorphine monotherapy for both mother and newborn, and could be a choice for oral opioid maintenance treatment during pregnancy 5.
• Gestational buprenorphine-naloxone exposure may result in subclinical fetal neurophysiological responses, including suppressed fetal heart rate and motor activity, at times of peak maternal buprenorphine/naloxone levels in later gestation 6.

Maternal and Neonatal Outcomes

• A lower risk for neonatal abstinence syndrome and a modestly lower risk for neonatal intensive care unit admission and small for gestational age have been observed with buprenorphine combined with naloxone compared to buprenorphine alone 3.
• No differences were observed with respect to major congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery 3.
• Most neonates born to mothers on buprenorphine-naloxone or buprenorphine maintenance treatment were born full-term with good Apgar scores, but may be of relatively small birth size 5.
• The need for pharmacological treatment for neonatal opioid withdrawal syndrome was lower in the buprenorphine-based groups than in the methadone group 5.

Treatment and Management

• Buprenorphine-naloxone treatment may confer substantial benefits for the treatment of opioid use disorder during pregnancy, including lower risk for overdose/death, less diversion potential, and reduced use of other substances 6.
• Careful planning for pain control during and after delivery and prevention of postpartum relapse risk are important considerations for postpartum women using Suboxone (buprenorphine/naloxone) 4.
• Emerging collaborative care models may be effective ways to deliver buprenorphine maintenance treatment, although more investigation is needed to generalize this to the obstetric setting 4.