Factors Contributing to U.S. Parents’ Decisions to Administer Melatonin to Children

Abstract

Objective:

Pediatric melatonin use is increasingly prevalent in the U.S. despite limited research on its efficacy and long-term safety. The current study investigated factors contributing to parents’ decisions whether to give children melatonin.

Methods:

Parents of children 1.0–13.9 years completed an online questionnaire on children’s health, sleep, and melatonin use. Parents who reported giving melatonin to their child were asked open-ended follow-up questions on why their child takes melatonin and why they stopped (if applicable). Responses were assigned to categories through thematic coding.

Results:

Data were analyzed on 212 children who either consumed melatonin in the past 30 days (n=131) or took melatonin previously (n=81). Among children who recently took melatonin, 51.1% exhibited bedtime resistance and 46.2% had trouble falling asleep. Parents most commonly gave children melatonin to: help them fall asleep (49.3%), wind down before bedtime (22.7%), facilitate changes in their sleep routine (17.5%), and/or change their circadian rhythm (11.4%). Parents stopped giving melatonin because their child did not need it anymore (32.0%), experienced negative side effects (9.3%), and/or concerns about health and safety (13.3%). Finally, parents initiated melatonin use on their own (50.0%), were encouraged by a friend or family member (27.4%), and/or followed the recommendation of a health provider (48.1%).

Conclusions:

Parents administered melatonin to children for a number of reasons and discontinued melatonin based on their own observations of a variety of effects. Parents frequently initiated use without the recommendation of a medical professional. Further research on indications and efficacy of melatonin and wider dissemination of guidelines are needed to help parents make informed decisions regarding children’s sleep health.

INTRODUCTION

Pediatric sleep problems are a common concern for parents. Approximately 20–25% of healthy children will experience some form of sleep problems¹, with a higher prevalence observed in children with neurodevelopmental disorders^2,3. Insufficient sleep during childhood is associated with cognitive and behavioral problems^4,5, as well as various risks to physical health outcomes⁶. Additionally, child sleep disturbances often result in increased stress and sleep disruption for the family⁷. To combat this, U.S. parents are increasingly turning to exogenous melatonin to help their children sleep^8–10.

Melatonin is an indoleamine hormone synthesized and released by the pineal gland. It begins to rise during the evening, peaks in the middle of the night, dissipates late in the night, and then remains low throughout the day. The endogenous secretion of melatonin initiates physiological changes, including thermoregulatory processes, that induce sleep¹¹. The nighttime rise in melatonin (dim-light melatonin onset) is commonly used as a marker of the timing of the circadian clock¹². When taken exogenously at specific times, melatonin both induces sleepiness (hypnotic) and shifts circadian timing (chronobiotic)¹¹. It is therefore utilized to treat both sleep onset insomnia and circadian rhythm disorders such as delayed sleep phase syndrome¹³. In much of the world, melatonin is considered a medication requiring a prescription; however, in the U.S. it is considered a dietary supplement and is under much weaker regulation. Guidelines for the effective use of melatonin for various indications and oversight of the contents of melatonin supplements are currently lacking.

Previous studies suggest that exogenous melatonin may be effective at promoting initiation and maintenance of sleep in children. In a recent review and meta-analysis of 8 randomized control trials (RCTs) examining melatonin efficacy in children and adolescents (ages 5 – 20 years) with idiopathic chronic insomnia, melatonin use resulted in a moderate increase in total sleep time (33.03 min) and moderate decrease in sleep onset latency (18.03 min) when compared to placebo, as assessed through sleep diaries¹⁴. Dosages used in the studies ranged from 1.0 to 10.0 mg and administration took place 1.5 to 2 h before children’s bedtimes. No effects on sleep efficiency or daytime functioning were observed. Melatonin has been reported to be effective at reducing sleep problems in both clinical (i.e., Attention Deficit Disorder (ADD), Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Neurodevelopmental disorders (NDD)) and non-clinical samples^15,16. A European study examining the efficacy of pediatric-appropriate prolonged release melatonin minitablets (PedPRM) in children with ASD and chronic sleep problems (ages 2 – 17.5 years) reported an average increase in parent-reported total sleep time of 57.6 min and decrease in sleep latency of 39.6 min after 13 weeks of treatment, compared to improvements of only 9.14 min and 12.5 min respectively with placebo¹⁷. Melatonin treatment also resulted in significant improvements to children’s externalizing behavior and caregivers’ quality of life¹⁸. PedPRM (Slenyto, Neurim Pharmaceuticals, Inc.) is currently the only licensed prescription sleep medication for children, and is indicated for the treatment of insomnia in children and adolescents with ASD or Smith-Magenis syndrome¹⁹; however, it is not currently approved for use in the United States.

A recent review across 19 previous studies reporting caregivers’ perspectives on the use of melatonin in children revealed that caregivers largely perceive melatonin as safe and effective at improving their children’s sleep problems, most often citing improvements in time to sleep onset and sleep quality²⁰. However, most of the studies reviewed (74%) were published prior to 2019. We recently reported survey results examining the current prevalence of pediatric melatonin use. Melatonin use in the past 30 days was reported in 5.6% of preschool-aged children, 18.5% of school-aged children, and 19.4% of pre-teens²¹. Given this surge in pediatric melatonin use, it is vital for healthcare providers to understand parents’ perception of melatonin and concerns regarding their children’s sleep health. The goal of the present analysis of parent-report, cross-sectional data was to further understand the factors contributing to parents’ decisions about whether to administer their children melatonin.

METHODS

Participants

Survey respondents were recruited from the greater Boulder/Denver community through flyers, tabling at local community events, and a database of parents who previously expressed interest in participating in research through the University of Colorado Boulder. Participants were also recruited across the United States through posts on various social media websites (e.g., Reddit, Twitter, Facebook), as well as paid targeted ads through Facebook. The University of Colorado Boulder Institutional Review Board approved all procedures and waived the written informed consent requirement. No compensation or incentives were offered for completing the survey.

Procedure

Data collection occurred between January and June 2023. Interested parents were directed to complete a survey conducted through Research Electronic Data Capture (REDCap), a secure web platform for designing and administering questionnaires. Consent information was provided at the top of the web page. Respondents were informed that the questionnaire assessed sleep patterns and sleep-related practices throughout childhood, rather than explicitly mentioning melatonin, so as not to influence the responses.

Parents were then asked about their child’s demographics, developmental and health history, sleep patterns, screen media exposure, and melatonin use. If a parent indicated that their child had either: 1) taken melatonin in the last 30 days, or 2) taken melatonin at some point previously, they were presented with additional follow-up questions. These questions concerned the frequency, timing, dosage, and duration of use (See Hartstein, et al., 2023²¹ for prevalence and characteristics of use), as well as the factors contributing to their decision to give their child melatonin, why they stopped giving their child melatonin (if applicable), and any side effects their child experienced from taking melatonin.

Analysis

Responses were included in the present analysis if parents reported that their child: 1) was between the ages of 1.0–13.9 years (calculated as the difference between reported date of birth and date of survey completion), 2) currently resides in the United States, and 3) either currently takes melatonin or has taken it at some point previously. Open-ended responses regarding the reason that parents started to give their child melatonin and why they stopped were analyzed through thematic coding²². Following a preliminary reading of all open-ended responses, an initial list of categories was generated based on recurring themes. Three researchers (LEH, BKH, MMG) then collaborated to code responses into the predetermined categories, adjusting categories as necessary to ensure they captured the nuances of each theme. Any disagreement in the independent coding was resolved through group consensus. Responses that did not fit into any category were coded as “other”. Missing data were excluded from the analysis for each individual variable, and percentages are calculated from the number of valid responses.

RESULTS

Parents of 1039 U.S. children ages 1.0–13.9 years completed the survey. Out of the total number of respondents, 207 (19.9%) did not provide a zip code. Of the 832 respondents who provided a zip code 493 (59.3%) resided in Colorado. The remaining 339 (40.7%) indicated zip codes across 40 different states.

Parents of 212 children reported their child either took melatonin in the past 30 days (N = 131, 12.6%) or took melatonin at some previous timepoint (N = 81, 7.8%), while 807 children (77.7%) had reportedly never taken melatonin. Children who had taken melatonin ranged in age from 2.35 years to 13.81 years (M = 7.60, SD = 2.99 years). Children who had never taken melatonin ranged in age from 1.01 to 13.90 years (M = 5.76, SD = 3.51 years). Demographic characteristics for both groups are summarized in Table 1.

Table 1.

Demographic characteristics of children who have taken melatonin at some point (N = 212) and children who have never taken melatonin (N = 807).

	Have taken melatonin	Never took melatonin
Demographic Variable	n (%)	n (%)
Sex	N = 208	N = 801
Male	88 (42.3)	389 (48.6)
Female	120 (57.7)	412 (51.4)
Race	N = 210	N = 771
White	186 (88.6)	664 (86.1)
Black or African American	2 (1.0)	6 (0.8)
Asian	2 (1.0)	14 (1.8)
Other	5 (2.4)	8 (1.0)
More than One Race	15 (7.1)	79 (10.2)
Ethnicity	N = 207	N = 790
Hispanic/Latino	21 (10.1)	72 (9.1)
Non-Hispanic/Latino	186 (89.9)	718 (90.9)
Primary caregiver education (highest degree earned)	N = 201	N = 791
Some high school	0 (0.0)	1 (0.1)
High school diploma or equivalent	4 (2.0)	4 (0.5)
Some college	8 (4.0)	24 (3.0)
Associate degree	5 (2.5)	16 (2.0)
Bachelor’s degree	60 (29.9)	247 (31.2)
Master’s degree	88 (43.8)	307 (38.8)
Professional degree	10 (5.0)	51 (6.4)
PhD	26 (12.9)	141 (17.8)
Yearly total family income before taxes	N = 203	N = 769
< $10,000	0 (0.0)	0 (0.0)
$10,000 – $24,999	1 (0.5)	8 (1.0)
$25,000 – $49,999	6 (3.0)	19 (2.5)
$50,000 – $74,999	12 (5.9)	24 (3.1)
$75,000 – $99,999	20 (9.9)	61 (7.9)
$100,000 – $149,999	61 (30.0)	200 (26.0)
$150,000 – $199,999	37 (18.2)	161 (20.9)
$200,000 +	66 (32.5)	296 (38.5)

Children who took melatonin in the past 30 days

Table 2 details parents’ responses regarding children’s health and development. Because past melatonin use may have predated diagnoses of sleep problems, this table only includes children who took melatonin in the past 30 days. 21.5% of children with recent melatonin use were diagnosed with or treated for ADD/ADHD, and 9.2% for Autism Spectrum Disorder (ASD). Only 5.3% of the children who recently took melatonin were diagnosed with or treated for a sleep disorder, such as a parasomnia, insomnia, or sleep apnea. Just over half (51.1%) of parents reported that their child currently resists or delays bedtime and 46.2% reported trouble falling asleep. Conversely, 24.4% of parents responded “no” to all questions about behavioral sleep problems.

Table 2.

Descriptive statistics of children’s health, development, and sleep.

	n (%) responding “Yes”
Has your child ever been diagnosed with or treated for:
ADD/ADHD? (N = 130)	28 (21.5)
Autism Spectrum Disorder? (N = 130)	12 (9.2)
Sleep disorder? (e.g., insomnia, parasomnia, obstructive sleep apnea syndrome) (N = 131)	7 (5.3)
Migraine or frequent headache? (N = 129)	5 (3.9)
Sleep-related questions
Does your child currently resist or delay bedtime? (N = 131)	67 (51.1)
Does your child currently have trouble falling asleep? (N = 130)	60 (46.2)
Does your child currently have trouble staying asleep? (N = 131)	44 (33.6)
Is your child currently difficult to get out of bed in the morning? (N = 131)	37 (28.2)

Children who took melatonin at any point

When asked what factors contributed to the decision to give their child melatonin (Figure 1), parents most frequently reported that they initiated melatonin use on their own (50.0%), followed by the recommendation of a pediatrician or nurse (38.0%), or a friend or family member (27.4%).

Figure 1. Factors influencing parents’ decisions to give their child melatonin (N = 208).

Respondents were instructed to “select all that apply” and several respondents selected more than one answer. Therefore, the percentages total more than 100%.

In detailing side effects that children experienced while taking melatonin (Table 3), the most common side effects reported were drowsiness (19.9%) and nightmares (6.1%). Three parents indicated that their child experienced side effects not listed, which included “pre-asthma”, hallucinations, and frequent waking associated with worry or “panic” that the medicine was keeping them awake. The majority of parents, however, reported no side effects (69.9%).

Table 3.

Side effects experienced by children from taking melatonin (N = 196)

	n (%)
Has your child experienced any of the following side effects from taking melatonin?
Drowsiness	39 (19.9)
Dizziness	1 (0.5)
Headache	1 (0.5)
Increased Bedwetting	4 (2.0)
Irritability	8 (4.1)
Nightmares	12 (6.1)
Low Blood Pressure	0 (0.0)
Nausea	1 (0.5)
Upset Stomach	1 (0.5)
Other	3 (1.5)
None	137 (69.9)

Note: Respondents were instructed to “select all that apply”. Several respondents selected more than one answer and several did not select any. Therefore, the percentages do not total 100%.

Table 4 details percentages of coded open-responses regarding reasons for starting and stopping melatonin administration. The most frequently reported reasons for giving melatonin were to help their child to fall asleep (49.3%) or to help them wind down before bedtime (22.7%). Parents also reported using melatonin to shift their child’s circadian rhythm (11.4%). When parents were asked why their child stopped taking melatonin, they most commonly indicated that they didn’t believe their child needed it anymore (32.0%). A smaller percent (13.3%) of parents cited concerns about whether it was healthy or safe for their child. Only 9.3% reported discontinuing use due to their child experiencing negative side effects and 8.0% didn’t believe it worked or was helpful.

Table 4.

Parent responses to open-ended questions on why their child took melatonin and why they stopped.

Category	Exemplar	n (%)
“What is/was the reason your child takes/was taking melatonin?” (N = 211)
To help wind down before bedtime	“He has a hard time calming down”	48 (22.7)
To help fall asleep	“Can’t fall asleep on her own”	104 (49.3)
To help with change in sleep routine (e.g., sick, napped, unfamiliar location)	“Days when she had a very long nap at school”	37 (17.5)
To help with change in circadian rhythm (e.g., time change, travel across time zones)	“Jetlag and occasionally to reset internal sleep clock 1–2 times per month”	24 (11.4)
Recommended by clinician (e.g., pediatrician, psychiatrist)	“Pediatrician recommended due to frequent and prolonged night wakings”	8 (3.8)
Other	“His sister needs melatonin to fall asleep, so we started giving it to both kids”	9 (4.3)
“What was the reason your child stopped taking melatonin?” (N = 75)
Child doesn’t need it anymore/It’s not necessary	“She found it easier to go to sleep”	24 (32.0)
Parent didn’t think it worked or was helpful	“It didn’t seem to have an effect”	6 (8.0)
Parental concerns about the health or safety of taking it	“Didn’t want to become dependent on the idea of “medicine” helping to fall asleep”	10 (13.3)
Only use/used it very occasionally	“We only use it once or twice a year”	18 (24.0)
Only used it for specific event (e.g., time change, travel across time zones)	“Only took melatonin for a couple of days to adjust for time difference”	15 (20.0)
Negative side effects	“Started having nightmares”	7 (9.3)
Other	“Ran out”	1 (1.3)

Note: Some responses covered more than one category. Therefore, the percentages total more than 100%.

DISCUSSION

The present study provides important and timely insights into parental decision-making regarding their children’s melatonin use. When asked the reason for giving their child melatonin, parents most frequently provided a response that was coded as “to help fall asleep” or “to help wind down before bedtime”. Similarly, approximately half (51.1%) of parents whose child recently took melatonin reported that their child currently resists or delays bedtime and 46.2% indicated that they had trouble falling asleep. Together, this indicates that parents are largely viewing melatonin as a hypnotic that can help overcome bedtime resistance or sleep onset difficulties.

In addition to soporific effects, exogenous melatonin can induce circadian phase shifts, with a phase response curve approximately 12 h offset from that of light²³. In adults, taking melatonin around bedtime results in minimal changes to the timing of the circadian system²⁴, and small doses near bedtime may actually induce a minor delay of the clock²⁵. A smaller percentage of parents (11.4%) indicated they gave their child melatonin in order to induce a circadian response, such as addressing a circadian phase delay, adjusting to daylight saving time, or traveling across time zones. To our knowledge, there are no data on the phase response to melatonin in children or adolescents. Further research is therefore required to understand the phase shifting effects of exogenous melatonin and the appropriate dosage and timing of administration to elicit both the desired hypnotic and chronobiotic response.

Across children who took melatonin in the past 30 days, parents reported that 21.5% had been diagnosed with or treated for ADD/ADHD and 9.2% for Autism Spectrum Disorder. To date, most randomized controlled trials of pediatric melatonin use have been conducted in children with neurodevelopmental disorders. Across studies, melatonin was shown to be effective at reducing sleep problems in children with ASD, with minimal side effects^26,27. Additionally, several parents stated in the present survey that they started giving their child melatonin to help counteract the effects on sleep from ADHD stimulant medication. A recent open-label clinical trial examined the impacts of 1 mg melatonin taken approximately 30 min before bedtime for one month on actigraphically-assessed sleep parameters in children and adolescents with ADHD currently taking a stimulant medication²⁸. A statistically significant increase in total sleep time was observed after 4 weeks of melatonin use as compared to baseline, with an average increase of 22 minutes. No significant changes to sleep onset latency, nighttime awakenings, or sleep efficiency were observed. Together, these findings suggest that melatonin may be a common and effective method for improving sleep in children with ASD or ADHD¹⁵. Additionally, a small percentage of children taking melatonin (3.9%) were reportedly diagnosed with or treated for migraine or frequent headaches. Several studies have examined the role of exogenous melatonin in the prevention and treatment of pediatric migraines. A review of complementary and integrative medicines for migraines in children and adolescents reports on four studies which examined the use of melatonin in migraine prevention²⁹. Three of the studies reported positive results, although melatonin was less effective than amitriptyline. The authors conclude that melatonin may be a safe preventative treatment for children experiencing primary headaches, but further research is still needed to confirm its efficacy.

Parents reported that their children experienced relatively few and minor side effects from taking melatonin. Although approximately 6% of parents reported their child experienced nightmares while taking melatonin, the mechanism underlying this association is currently unknown. This represents an important area for future research, especially given the high prevalence of melatonin use in the foster care system where children may have a history of trauma exposure¹⁰. Additionally, only a minority of parents cited negative side effects (9.3%) or concerns about health and safety (13.3%), as the reason why their child stopped taking it. This is consistent with prior literature suggesting that melatonin supplements are generally safe and well-tolerated in short-term pediatric use²⁷, and that parents view them positively as being “natural”³⁰. However, adverse events have occasionally been reported. Between 2012 and 2021, the number of pediatric melatonin ingestions that were reported to the U.S. national poison data system increased 530%, though the majority of cases (84.4%) were asymptomatic.³¹ Safety concerns about pediatric melatonin use are compounded by a recent analysis of over-the-counter gummy supplements available in the U.S. in which the actual melatonin content ranged from 74% to 347% of the advertised content³². Because gummies are a popular delivery system for melatonin in children²¹, this inconsistency in quality of available products poses a potential risk for unintentional overdose. Future research should explore potential associations between the dosage and content of supplements being administered to children and parents’ perceptions of efficacy and safety concerns.

Data on the safety of long-term melatonin use in children are also lacking, and concerns have been raised that melatonin use in pre-pubescent children could influence the onset of puberty^33,34. To our knowledge, few studies have examined pubertal development across extended melatonin use in humans. In one study of children with ASD taking melatonin nightly for up to 2 years, physician-completed Tanner pubertal staging scores were found to be within the normal range for participants’ ages (N = 31)³⁵. Conversely, in another study, adolescents and young adults (N = 33) with an average melatonin use duration of 7.1 years self-reported (i.e., one question with options: “much earlier”, “somewhat earlier”, “about the same”, “somewhat later”, “much later”) that they felt the timing of their pubertal development was delayed compared to peers³⁶. Given the increasing prevalence of pediatric melatonin use, further research on a larger scale is imperative to establish the safety of long-term use.

Parents frequently reported initiating melatonin use for their children either on their own or at the advice of a family member or friend, and fewer than half of parents reported that their decision was influenced by a recommendation from a medical professional. In a study examining Twitter posts about alternative sleep aids for children, the majority of posts were published by random users (84.2%), with only 1.4% of observed posts coming from healthcare professionals or academic institutions³⁷. Given this, there is concern that parents may be receiving misinformation on the proper dosing, safety, and efficacy of pediatric melatonin, especially considering the lack of published scientific research and variable quality of available melatonin supplements.

Some limitations to this analysis should be noted. Survey respondents predominantly identified as white and reported relatively high levels of income and education. These findings, therefore, may not be generalizable to a broader, more diverse population. All data are parent-report and are therefore vulnerable to factual error or unintentional biases. Because the survey was designed to be brief to limit participant burden, the omission of certain questions may have prevented us from better capturing the nuances underlying parents’ decisions regarding melatonin use. For example, parents did not have the opportunity to clarify any specific circumstances underlying their child’s bedtime resistance or sleep disturbance, or to indicate whether they are implementing behavioral or other strategies in conjunction with melatonin to help improve their child’s sleep. Additionally, we did not examine characteristics or health of the parent which may be relevant, particularly in light of recent findings that parental stress may provide a link between children’s sleep disturbances and increased melatonin use³⁸. Finally, the survey listed “drowsiness” as a possible side effect without clarifying that it was referring to daytime drowsiness. Future research utilizing structured interviews with parents may provide a clearer understanding of the individual circumstances contributing to children’s melatonin use.

In summary, parents reported giving their child exogenous melatonin for a variety of reasons, most frequently to combat bedtime resistance and sleep onset difficulties, as well as help with occasional changes in their regular sleep routine or circadian rhythms. They reported few and minor side effects. A fairly high percentage of children were diagnosed with ADHD or ASD relative to the general population. However, many parents indicated initiating melatonin use on their own or at the advice of a family member or friend, without the recommendation of a medical professional. Wider dissemination of guidelines and safety concerns from the research and medical communities is vital to support parents in making informed decisions about their child’s melatonin use.

HIGHLIGHTS.

• For children recently taking melatonin, 51.1% currently resist bedtime and 45.8% have trouble falling asleep

• Parents’ most commonly reported reasons for giving melatonin to their children were to help them wind down before bedtime or fall asleep

• Parents frequently initiated melatonin use on their own, without recommendation from a medical professional