Cough and Cold Medicines and Antihistamines: Infant "sleep aides"?

All of us (at the UC Davis Human Lactation Center) have been traveling quite a bit. Jane was in Chicago a couple of weeks ago and heard a young father carrying a young baby tell another airline passenger, “She was so good; it must have been the Benedryl.” She’s also heard health professionals and WIC staff talk about parents using cough and cold medicines to get their babies to sleep. Warnings against “off label” use to sedate babies have started to appear on labels of some pediatric over-the-counter medications.

Some parents may give cough and cold medicines (CCM) or antihistamines to infants and young children to deal with their behavior. An Australian study interviewed 40 parents of young children and reasons stated for “treatment” with CCMs included behaviors such as “she wasn’t her normal self,” he was “grumpy,” she “was generally unhappy,” or he was “whining” and “cranky.” CCMs also were given to help children calm down or sleep. One parent said: “To keep functioning, my wife and I have to have a good night’s sleep. So we trade off giving the drug to have a good night’s sleep.” I’m sure our readers will not be surprised that we find this practice particularly scary. 1

One of the most commonly used antihistamines is diphenhydramine hydrochloride, the active ingredient found in Benadryl. Only one study has tested the safety of the use of this antihistamine in children, and those children were aged 2-12. 2 There are no published studies of the safety or effectiveness of diphenhydramine in children younger than 2 years; however, according to one study of pediatricians in the US, 1/2 reported they had recommended antihistamines (at least once in the past 6 months) be given to children aged 0 to 2 years for “sleep problems.”3 According to another study, less than 10% of children under 2 years had been given antihistamines. Though use of CCM to sedate young children may not be widespread, it is indeed dangerous. So, we wanted to share some information with you just in case you know anyone who has decided to use these medications to get their children to sleep.3

Safety Warnings
The Centers for Disease Control and Prevention (CDC) has linked cough and cold medicines (including antihistamines) to >1500 emergency department visits and 3 deaths in 2004–2005 among children under 2 years of age. In 2004, the US Food and Drug Administration (FDA) added a warning to the label of promethazine, an antihistamine similar to Benadryl, which contraindicated their use in children under 2 years of age. 4 The warnings were based on “continued reports of serious adverse events, such as respiratory depression and central nervous system reactions, including seizures.” The FDA recently enforced measures against unapproved marketing of the antihistamine carbinoxamine to young children because of reports of 21 deaths that were associated with use of this drug in children who were younger than 2 years. Many antihistamines cross the blood-brain barrier, affecting the central nervous system (CNS) and potentially causing sedation. In some infants and children, antihistamines can have the opposite effect of sedation by stimulating the CNS resulting in irritability, nervousness or insomnia. Another negative “side effect” of antihistamine or CCM use in children is that parents may delay seeking medical care because the medication masks the symptoms of an underlying illness.

They aren’t safe, but are they effective?
One study, ironically named the “TIRED study” was designed to examine how infants respond to diphenhydramine. Not only did the study results show no improvement in infant sleep problems at the commonly used dose, the trial was stopped early because of lack of effectiveness of diphenhydramine over placebo. 3

What if children need these medications?
When children are ill or have severe allergies, pediatric formulations of cough and cold medications may be very useful. These medications were intended for intermittent use in children who are under a doctor’s care. But parents need to be told that these medications are not supposed to be used daily by anyone and they might be particularly dangerous to infants. Parents should talk to their pediatricians before using any medications with their babies.

A Final Note
Please don’t think we don’t understand how exhausting and challenging it is to have an older infant or toddler that is not “sleeping through the night.” We ALL have been in that sleep deprived haziness at one time or another. We've shared our experience along with a few tips for sleepy parents in our previous posts “Thoughts from a Sleep Deprived Mom” and Tips from the Trenches: Surviving Sleep Deprivation. Thanks to all of you for passing these words along and please continue to send us your feedback!

Next time: Let’s Talk about Tantrums

References
1. Allotey, P., Reidpath, D.D., & Elisha, D. "Social Medication" and the Control of Children: A Qualitative Study of Over-the-Counter Medication Among Australian Children. (2004). Pediatrics. 114, e378-383.
2. Vernacchio, L., et al. Cough and cold medication use by US children, 1999-2006: results from the slone survey. (2008). Pediatrics, 122, e323-329.
3. Merenstein, D., et al. The Trial of Infant Response to Diphenhydramine The TIRED Study—A Randomized, Controlled, Patient-Oriented Trial. (2006). Arch Pediatr Adolesc Med. 160, 707-712.
4. Simons, F.E.R. Diphenhydramine in Infants. (2007). Arch Pediatr Adolesc Med. 161, 105.