Sufentanil

The Basics

What is Sufentanil?

Used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent.

Brand names for Sufentanil

Dsuvia

How Sufentanil is classified

Analgesics – Opioid, Narcotics, Anesthetics – Intravenous, Opiates

Sufentanil During Pregnancy

Sufentanil pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Sufentanil while pregnant

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no available data with sufentanil in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, embryolethality and maternal toxicity were noted in rabbits when sufentanil was administered intravenously at 4.4 times the maximum human daily dose of 360 mcg/60 kg/day, based on a body surface area comparison during organogenesis. Decreased live fetuses and pup survival were noted in rats treated with sufentanil late in gestation and throughout lactation at doses below the human daily dose of 360 mcg. No malformations were observed in either rats or rabbits at doses below the human daily dose of 360 mcg . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Taking Sufentanil While Breastfeeding

What are recommendations for lactation if you're taking Sufentanil?

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of sufentanil ingested by the neonate are small and would not be expected to cause any adverse effects in breastfed infants. Labor pain medication may delay the onset of lactation; however, it appears that with good breastfeeding support, epidural sufentanil plus a local anesthetic has little or no effect on breastfeeding success.[1][2] Because of sufentanil’s long half-life during continued intravenous infusion or repeated intravenous administration,[1] sufentanil levels in milk would be expected to increase if used for an extended period postpartum. Once the mother’s milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of sufentanil to a few days. Because there is no published experience with repeated doses of intravenous or sublingual sufentanil during established lactation, other agents may be preferred, especially while nursing a newborn or preterm infant. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Maternal / infant drug levels

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of sufentanil ingested by the neonate are small and would not be expected to cause any adverse effects in breastfed infants. Labor pain medication may delay the onset of lactation; however, it appears that with good breastfeeding support, epidural sufentanil plus a local anesthetic has little or no effect on breastfeeding success.[1][2] Because of sufentanil’s long half-life during continued intravenous infusion or repeated intravenous administration,[1] sufentanil levels in milk would be expected to increase if used for an extended period postpartum. Once the mother’s milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of sufentanil to a few days. Because there is no published experience with repeated doses of intravenous or sublingual sufentanil during established lactation, other agents may be preferred, especially while nursing a newborn or preterm infant. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Possible effects of Sufentanil on milk supply

Narcotics can increase serum prolactin.[6][7] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

A national survey of women and their infants from late pregnancy through 12 months postpartum compared the time of lactogenesis II in mothers who did and did not receive pain medication during labor. Categories of medication were spinal or epidural only, spinal or epidural plus another medication, and other pain medication only. Women who received medications from any of the categories had about twice the risk of having delayed lactogenesis II (>72 hours) compared to women who received no labor pain medication.[8]

A nonrandomized convenience sample of women who did (n = 209) or did not (n = 157) receive epidural analgesia during labor was analyzed to determine whether epidurals affected the onset of lactation. Although not standardized, the typical procedure used sufentanil 10 to 15 mg together with either ropivacaine 0.1% or levobupivacaine 0.0625% epidurally, supplemented by epidural boluses of ropivacaine 0.1% or levobupivacaine 0.0625% about every 2 hours. No difference was found in the time of lactation onset between the two groups. Although women in both groups stated they wished to breastfeed prior to delivery, exclusive breastfeeding at 20 days postpartum was less frequent in the women who received an epidural (43%) than in women who did not (57%).[9]

In a study in China, women with a scheduled cesarean section were randomized to receive intravenous patient-controlled analgesia with either sufentanil or tramadol. Postpartum prolactin levels were higher in the tramadol group (348 mcg/L) than in the sufentanil group (314 mcg/L). The onset of lactation was sooner in the tramadol group (21.4 hours) than in the sufentanil group (25.1 hours). Both of these difference were statistically significant.[10] Note that injectable tramadol is not available in the U.S.

Possible alternatives to Sufentanil

Acetaminophen, Butorphanol, Fentanyl, Hydromorphone, Ibuprofen, Morphine.