When a Newborn Goes Through Opioid Withdrawal, Timing the Medicine to the Baby Helps

A large US study, OPTimize NOW, tested giving opioid medicine only when a baby needs it — and found babies were ready to go home sooner

A big new study found that when newborns going through opioid withdrawal need medicine, giving a dose only when their symptoms flare up — instead of a fixed, around-the-clock schedule — helped them become medically ready to go home about two days sooner and with far less total medicine. Importantly, this "as-needed" approach was just as safe as the traditional method. The findings apply to babies cared for with a gentle, family-centered method called Eat, Sleep, Console.

Why This Matters

Some babies are born to mothers who used opioids during pregnancy — sometimes prescription medicines that treat opioid addiction, sometimes other opioids. After birth, these babies can go through withdrawal, a condition doctors call neonatal opioid withdrawal syndrome, or NOWS. Withdrawal can make a newborn irritable, hard to settle, tremulous, and unable to feed or sleep well, because the baby's body has become used to the opioid before birth and reacts when it is no longer present. It is common: in the United States, a baby is diagnosed with this condition roughly every 27 minutes [1]. For families, it can mean a frightening and lengthy hospital stay at the very start of their child's life [2].

Most babies with withdrawal do not need any medicine at all — the first and most important treatment is calm, comforting care: a quiet, dimly lit room, gentle rocking, skin-to-skin holding, and frequent feeding. But when withdrawal is severe enough that comfort measures are not enough, doctors add an opioid medicine to ease the baby safely through the hardest days. The question this study set out to answer is not whether to use that medicine, but how best to give it — and that turns out to make a real difference for how quickly babies recover.

How Care Used to Work — and How It Changed

For many years, doctors judged how severe a baby's withdrawal was using a long checklist of symptoms, a method developed in the 1970s [3]. If a baby scored high enough, the team started an opioid medicine on a fixed schedule — regular doses given by the clock — then slowly lowered the amount over days or weeks [4]. This kept babies comfortable, but it also meant many received continuous medicine and stayed in the hospital a long time, whether or not their withdrawal really required it [2].

The biggest recent change was a shift in how babies are watched. Instead of tallying symptoms, a method called Eat, Sleep, Console asks three simple, human questions: Can the baby eat? Can the baby sleep? Can the baby be comforted? It leans heavily on keeping parents at the bedside, holding, feeding, and soothing their baby before reaching for any medicine [5]. A large trial showed that this approach got babies home much faster and meant far fewer of them needed opioid medicine at all — without any sign of harm [6]. But that trial answered only when to start medicine. It left open a second question: once a baby does need an opioid, what is the best way to give it? [1]

What the Researchers Did

The OPTimize NOW study set out to answer that second question carefully [1]. Twenty-three hospitals across the United States took part. Rather than assigning individual babies, the study asked each hospital to use one dosing method for about five months and then switch to the other, so that every hospital tried both. One method was the traditional scheduled taper — regular doses by the clock, then a slow wean. The other was "symptom-based" dosing: give a single dose only when the baby's withdrawal reaches a set point, keep watching, and give another dose only if the symptoms come back [1].

The study built in an important safety rule. If a baby needed several doses close together — three doses in a day, or two quick doses in a row — that signaled the withdrawal was strong enough to need steady, scheduled medicine, and the team switched over to the traditional method [1]. In other words, the as-needed approach was never meant to leave a struggling baby under-treated; it had a clear plan to step up care when needed.

What They Found

Among the 383 babies cared for with Eat, Sleep, Console, those on the symptom-based method became medically ready to leave the hospital about 2.3 days sooner — roughly 9 days instead of about 12 [1]. "Medically ready" means the baby was old enough and had gone long enough without needing medicine to be considered stable to go home [5]. The babies on the as-needed method also received much less medicine overall: fewer total doses, fewer days on opioids, and less need for a second calming medicine [1],[7].

Two other findings help set expectations. The dosing method did not change how likely a baby was to need any medicine in the first place — about 40% did either way — because that depends on how withdrawal is assessed, not on how the medicine is given [1]. And while babies became medically ready sooner, the total time in the hospital was not clearly shorter. That is because going home also depends on things medicine cannot speed up, like social-work planning and making sure the baby has a safe place to go [2],[8]. About one in three babies on the as-needed method eventually needed to switch to scheduled dosing because their withdrawal was too strong for occasional doses — exactly the situation the safety rule was designed to catch [1].

Reassuringly, the as-needed approach was just as safe. Serious problems were rare in both groups, there were no in-hospital deaths, and babies on the as-needed method did not end up needing more emergency or urgent care in the three months after going home [1],[9]. The study did note that the benefit was clearest for babies watched with Eat, Sleep, Console; in hospitals still using the older symptom-checklist method, the results were less clear-cut [1],[3].

Why would giving less medicine, less often, actually help babies recover faster? The likely reason is that opioids given on a fixed schedule keep a steady level of the drug in the baby's system, which can prolong the very dependence the treatment is trying to resolve. By giving a dose only when the baby truly needs it, the as-needed method lets the baby's body adjust more naturally, so the medicine can be stopped sooner. This idea — that matching treatment closely to a baby's real needs, rather than following a rigid routine, can lead to gentler and faster recovery — is the same principle behind the Eat, Sleep, Console approach itself [1],[6]. It reflects a broader shift in newborn care toward doing only what each individual baby requires, no more and no less.

What This Means for Families

If your baby is being cared for for opioid withdrawal, this study is encouraging news. It suggests that a gentler, "give medicine only when it's truly needed" strategy — paired with the family-centered Eat, Sleep, Console approach — can mean less total medicine for your baby and a faster path to being medically ready for home, without added risk [1],[6]. It also underscores something families have long known: your presence matters. Holding, feeding, and soothing your baby is not just comfort — it is a central part of the treatment [5],[10].

It helps to keep expectations realistic, too. Your baby's total hospital stay may still take time, because leaving the hospital safely involves planning beyond the medicine itself — arranging follow-up, support at home, and making sure everything is in place for a safe discharge [2]. The study found that babies reached the point of being medically ready sooner, even though the overall stay was not always shorter. And some babies simply need steady, scheduled medicine — that is not a setback, just a sign their care team is carefully matching treatment to what your baby needs [1].

If your family is going through this, it is worth remembering that you are part of the treatment, not a bystander to it. Ask your care team how they decide when your baby needs a dose, what signs they are watching for, and how you can help soothe your baby between assessments. Being present, learning your baby's cues, and taking part in comforting care can make a genuine difference — both during the hospital stay and in the transition home [5],[6].

What Researchers Are Working On Next

This study followed babies for three months, so the most important remaining question is about the long term: how children who were treated this way grow, learn, and develop over the years ahead [11]. The research team behind OPTimize NOW is planning longer follow-up to answer exactly that. For now, the study gives doctors and families solid evidence that, for babies going through opioid withdrawal, timing the medicine to the baby — rather than the clock — is a safe and effective way to help them heal and head home [1].

References

  1. Devlin LA, Babineau DC, Merhar SL, et al. Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial. JAMA. Published online April 25, 2026. doi:10.1001/jama.2026.5782 ↩
  2. Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012;307(18):1934-1940. doi:10.1001/jama.2012.3951 ↩
  3. Finnegan LP, Connaughton JF Jr, Kron RE, Emich JP. Neonatal abstinence syndrome: assessment and management. Addict Dis. 1975;2(1-2):141-158. ↩
  4. Hudak ML, Tan RC; Committee on Drugs, Committee on Fetus and Newborn. Neonatal drug withdrawal. Pediatrics. 2012;129(2):e540-e560. doi:10.1542/peds.2011-3212 ↩
  5. Patrick SW, Barfield WD, Poindexter BB; Committee on Fetus and Newborn, Committee on Substance Use and Prevention. Neonatal Opioid Withdrawal Syndrome. Pediatrics. 2020;146(5):e2020029074. doi:10.1542/peds.2020-029074 ↩
  6. Young LW, Ounpraseuth ST, Merhar SL, et al. Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal. N Engl J Med. 2023;388(25):2326-2337. doi:10.1056/NEJMoa2214470 ↩
  7. Disher T, Gullickson C, Singh B, et al. Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis. JAMA Pediatr. 2019;173(3):234-243. doi:10.1001/jamapediatrics.2018.5044 ↩
  8. Grossman MR, Berkwitt AK, Osborn RR, et al. An Initiative to Improve the Quality of Care of Infants With Neonatal Abstinence Syndrome. Pediatrics. 2017;139(6):e20163360. doi:10.1542/peds.2016-3360 ↩
  9. Wachman EM, Schiff DM, Silverstein M. Neonatal Abstinence Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018;319(13):1362-1374. doi:10.1001/jama.2018.2640 ↩
  10. Kraft WK, Adeniyi-Jones SC, Chervoneva I, et al. Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome. N Engl J Med. 2017;376(24):2341-2348. doi:10.1056/NEJMoa1614835 ↩
  11. Devlin LA, Merhar SL, Babineau DC, et al. Optimizing pharmacologic treatment for neonatal opioid withdrawal syndrome (OPTimize NOW): a symptom-based dosing approach study protocol for a multi-center, cluster crossover design randomized controlled trial. Trials. 2025;26:399. doi:10.1186/s13063-025-09035-x ↩