From the Guidelines
Yes, Zoloft (sertraline) can cause neonatal withdrawal syndrome in babies born to mothers who took the medication during pregnancy, particularly in the third trimester. This condition, also called neonatal discontinuation syndrome, typically appears within the first few days after birth and may include symptoms such as irritability, excessive crying, tremors, feeding difficulties, sleep disturbances, hypoglycemia, respiratory distress, and seizures in severe cases. The risk increases with higher doses and longer duration of maternal sertraline use closer to delivery. These symptoms occur because the baby's developing brain becomes accustomed to sertraline crossing the placenta during pregnancy, and after birth, the sudden discontinuation leads to withdrawal effects.
According to a study published in Pediatrics in 2012 1, selective serotonin reuptake inhibitors (SSRIs), including sertraline, can cause a constellation of neonatal signs that include continuous crying, irritability, jitteriness, and/or restlessness; shivering; fever; tremors; hypertonia or rigidity; tachypnea or respiratory distress; feeding difficulty; sleep disturbance; hypoglycemia; and seizures. The onset of these signs ranged from several hours to several days after birth and usually resolved within 1 to 2 weeks.
Some key points to consider:
- The symptoms of neonatal withdrawal syndrome can be mild to severe and may require supportive care.
- Healthcare providers should be informed about maternal sertraline use so they can monitor the newborn appropriately.
- Despite the risk of neonatal withdrawal, abruptly stopping sertraline during pregnancy is not recommended as the benefits of treating maternal depression often outweigh the risks of neonatal withdrawal, as noted in the same study 1.
- The study also highlights the importance of continuing SSRI treatment during pregnancy at the lowest effective dose, as withdrawal of medication may have harmful effects on the mother-infant dyad.
In terms of management, a short-term course of chlorpromazine may provide measurable relief of symptoms in severely affected infants, as mentioned in the study 1. However, most cases of neonatal withdrawal syndrome are self-limiting and resolve within 1-2 weeks without specific treatment beyond supportive care.
It is essential to weigh the risks and benefits of sertraline use during pregnancy and to closely monitor newborns for signs of withdrawal syndrome. As stated in the study, clinicians should be aware that infants are at risk for manifesting clinical signs of drug toxicity or withdrawal over the first week of life and arrange for early follow-up after the initial hospital discharge 1.
From the FDA Drug Label
Neonates exposed to sertraline and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome
Yes, Zoloft (sertraline) can cause neonatal withdrawal. The clinical findings are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome 2.
From the Research
Neonatal Withdrawal Syndrome and Zoloft (Sertraline)
- Zoloft, also known as sertraline, is a selective serotonin reuptake inhibitor (SSRI) used to treat depression and other mental health conditions.
- There is evidence to suggest that SSRIs, including sertraline, can cause neonatal withdrawal syndrome in infants exposed to these medications during the third trimester of pregnancy 3.
- Neonatal withdrawal syndrome is characterized by symptoms such as irritability, constant crying, shivering, increased tonus, eating and sleeping difficulties, and convulsions 3.
- A study found that neonatal withdrawal syndrome can occur after third trimester in utero SSRI exposure, and that symptoms can last up to one month after birth 3.
- Another study found that the incidence of withdrawal symptoms was high in neonates delivered by women taking psychotropic or anticonvulsant drugs, including SSRIs, and that the risk increased when a mother was taking multiple drugs 4.
- Breastfeeding appeared to protect against withdrawal symptoms in neonates exposed to psychotropic or anticonvulsant drugs during pregnancy 4.
- The Finnegan scale is widely used to recognize withdrawal from psychotropic medication, including SSRIs, and an observation period of at least 48 hours post-partum is advised to detect withdrawal symptoms 5.
- Treatment for neonatal withdrawal syndrome may include supportive measures such as feeding on demand and swaddling, as well as pharmacologic intervention with medications like phenobarbital in severe cases 5, 6.