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Reporting a Medication Error

Sleep Aid Medicine Patches Should Not Be Used on Children

Published December 17, 2024

We received a report from a parent about a sleep aid patch (Figure 1) that was applied to their child’s skin while at daycare. They found the patch on their child’s skin when they arrived home after picking up their child from daycare. When they asked the staff how this patch got on their child’s skin, they were told that their child’s teacher put it on the child to help them fall asleep during naptime.

Figure 1. PureBreathe Revixa Tape Peaceful Sleep patch is a sleep aid that contains 6 mg of melatonin and intended for adult use only.

The patch was labeled “PureBreathe Revixa Tape Peaceful Sleep” and had a graphic of a moon, stars, and clouds. No other information was on the patch. A quick search on the internet found that the patch contains melatonin. They are sold in a pouch that contains 30 patches. The pouch includes the list of ingredients (Figure 2) on the back panel and lists melatonin 6 mg as the first ingredient. The patch also included several other ingredients that could have harmed the child, especially if they had an allergy to one of the other ingredients. In addition, to the right of ingredient information it states in bold print, “For adult use only.” Then, another statement goes on to say, “NOT intended for individuals under the age of 18 years.”

Figure 2. The back panel of the pouch that contains30 PureBreathe patches lists the first ingredient as melatonin 6 mg. To the right of the ingredient list, it says, “For adult use only.”

We are not sure why the child’s teacher thought it was safe to use that patch on the child or if they even had the information that was on the outer pouch that contained the patches.

Melatonin is a hormone produced by the body that helps with sleep. If you have trouble sleeping, taking melatonin supplements, or using a melatonin patch may help. The US Food and Drug Administration (FDA) does not regulate melatonin and has not approved its use in children or adolescents who have difficulty sleeping. However, some doctors may recommend low doses of melatonin for some children after other non-medicine treatment options have been exhausted.

Here’s what you can do: If your child has difficulty sleeping, talk with their doctor about non-medicine options (behavioral modifications) that may help your child sleep. Never give your child a dose, or a partial dose, of medicine meant for an adult or an older child. Adult medicines are formulated specifically for an adult body. Children's bodies are less developed. An adult medicine could work very differently on them or cause serious side effects. Before giving your child any medicine always look at the Drug Facts label for directions and check with your child’s doctor or pharmacist to confirm if the medicine is safe to use and what dose to give.

Familiarize yourself with how medicines are handled and administered at your child’s daycare or the school they attend. Parents need to ensure that childcare providers only give medicines, including prescription, over-the-counter (OTC), and supplements that are provided to the daycare facility or caregiver by the parent; no other medicines or supplements should be given to the child without the parent’s written permission. In addition, parents need to give explicit instructions to the caregiver on how, when, and how much medicine should be given to their child. Daycare providers should NEVER give a child someone else’s medicine. Visit our page Medication Safety Tips When Your Child Is at School for step by step safety tips.

Do not refer to medicine patches as band-aids, stickers, or tattoos. Young children may stick them on their skin if a patch is found on the floor. Medicine patches not intended for the person can be extremely dangerous.

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