Question 10: Is methadone safe for pregnant women and their infants?

Answer: Yes. Since the early 1970s, methadone maintenance treatment has been used successfully with pregnant women. There is consensus that methadone can be safely administered during pregnancy with little risk to mother and infant. Maintenance on methadone is necessary to prevent relapse to illicit opioid use and thus to maintain optimal health during pregnancy.

Research Highlights

A systematic review revealed that randomized controlled studies of methadone treatment in pregnancy demonstrate an approximate threefold reduction in heroin use and a threefold increase in retention in treatment relative to nonpharmacologic treatment (Rayburn and Bogenschutz, 2004).

  • All drug-using women are considered to be at higher-than-normal risk for medical and obstetrical complications. Methadone-maintained women show a far greater improvement in obstetrical health than untreated women. Hepatitis types A, B, and C and other sexually transmitted diseases; bacterial endocarditis; septicemia; and cellulites are common among active injection drug users, particularly those who share needles. Women maintained on methadone who have stopped illicit drug use and injection before pregnancy are less likely to experience these and other medical complications during pregnancy. Obstetrical complications such as spontaneous abortion, placental insufficiency, and other conditions also occur at a lower rate among methadone-maintained women than among opioid-dependent women not enrolled in treatment. When compared with opioid-addicted women not in treatment, women in methadone maintenance treatment have been observed to maintain better overall health and nutritional status during pregnancy because of stability provided through treatment. In addition, methadone clinics can provide onsite prenatal services or link patients to these services in nearby clinics, coordinating addiction treatment and prenatal care to optimize both (Kaltenbach, Silverman, and Wapner, 1993).
  • Some women in methadone maintenance treatment are infected with HIV before pregnancy. Treatment programs that link women to appropriate medical care during pregnancy may reduce the burden of illness suffered by HIV-infected women. In a study of 191 methadone-maintained women in a New York City clinic with extensive medical linkages, medical and obstetrical complications did not differ among women with and without HIV infection. HIV infection occurred among 37 percent of women, most of whom were asymptomatic for HIV disease and AIDS before pregnancy. Adverse birth outcomes were relatively infrequent and occurred at approximately the same rates as observed in studies of methadone-maintained women before the HIV epidemic (Selwyn, Schoenbaum, Davenny, et al., 1989).
  • U.S. research in the 1970s demonstrated that methadone does cross the placenta. Passive exposure to methadone in utero can result in neonatal abstinence syndrome among exposed infants. The syndrome varies considerably and depends on a number of factors, including the use of other drugs during pregnancy, anesthesia during delivery, the maturational and nutrional status of the infant, and other aspects of maternal health that affect the fetal environment. The relationship of maternal methadone dose in the last trimester of pregnancy has been explored in a number of studies, but results have not consistently delineated a dose-response relationship between maternal dose and severity of infant abstinence syndrome. For those neonates experiencing withdrawal, the length and severity of the withdrawal vary greatly; however, pharmacotherapy for neonatal methadone abstinence syndrome is simple and effective. Methadone maintenance treatment affords protection of the fetus from erratic maternal opioid levels and repeated episodes of withdrawal typically seen in users of illicit opioids (Finnegan, 1991).
  • The majority of infants exposed to methadone in utero are healthy and have fewer adverse outcomes than infants exposed to heroin and other illicit drugs. Methadone maintenance treatment for pregnant women can reduce in utero growth retardation and neonatal morbidity and mortality, in comparison with women not in treatment (Kaltenbach and Finnegan, 1984).

A review of the literature on methadone and lactation reveals that the amount of methadone in breast milk is very small and depends on the dose of methadone that a mother is receiving. The amount of methadone received by an infant from breast milk is not enough to prevent neonatal abstinence syndrome. Therefore, even though a mother is receiving methadone, her infant may require additional opiate treatment of neonatal abstinence syndrome (Jansson, Velez, and Harrow, 2004).

Methadone Safety for Pregnant Women and Their Infants – Figure 24 outlines key points discussed in the research citations above regarding the safety of methadone maintenance treatment for pregnant women.

Figure 24 illustrates the safety of methadone maintenance treatment for pregnant women and their infants. Methadone maintenance: reduces adverse pregnancy outcomes, reduces adverse birth outcomes, infant withdrawal is treatable, and shows no long-term adverse neurobehavioral consequences to in utero exposure.

Figure 24 illustrates the safety of methadone maintenance treatment for pregnant women and their infants.



Finnegan L. Treatment issues for opioid-dependent women during the perinatal period. Journal of Psychoactive Drugs 1991;23:191-201.

Jansson LM, Velez M, Harrow C. Methadone maintenance and lactation: a review of the literature and current management guidelines. Journal of Human Lactation 2004;20(1):62-71.

Kaltenbach K, Finnegan L. Developmental outcome of children born to methadone maintained women: a review of longitudinal studies. Neurobehavioral Toxicology and Teratology 1984;6:271-75.

Kaltenbach K, Silverman N, Wapner R. Methadone maintenance during pregnancy. In: State Methadone Treatment Guidelines. Rockville MD: U.S. Department of Health and Human Services, 1993.

Rayburn WF, Bogenschutz MP. Pharmacotherapy for pregnant women with addictions. American Journal of Obstetrics & Gynecology 2004;191(6):1885-97.

Selwyn P, Schoenbaum E, Davenny K, Robertson VJ, Feingold AR, Shulman JF, et al. Prospective study of human immunodeficiency virus infection and pregnancy outcomes in intravenous drug users. JAMA 1989;261:1289-94