INTRODUCTION — Behavioral sleep problems (behavioral insomnia) in children include bedtime refusal or resistance, delayed sleep onset, and prolonged night awakenings requiring parental intervention. All of these issues are common in the pediatric population and often adversely affect the quality of life of both children and caregivers. While most children experience occasional transient insomnia, more persistent insomnia carries an increased risk of mood and behavior problems, academic failure, and even worsened health-related conditions [1].
Medical issues, including medications, pain, and primary sleep disorders (eg, obstructive sleep apnea, restless legs syndrome) may also cause sleep problems either directly or by creating conditions that contribute to unhealthy sleep practices (eg, irregular sleep-wake patterns) or negative sleep onset associations (eg, needing a parent present in order to fall asleep).
The causes and interventions appropriate to behavioral sleep problems, which are the most common sleep issues in children, will be reviewed here. The general clinical evaluation of sleep problems in children, including the steps needed to determine whether the problem is behavioral in origin, is discussed in detail elsewhere. (See "Assessment of sleep disorders in children".)
TYPES OF CHILDHOOD INSOMNIA — The 2014 revision of the International Classification of Sleep Disorders (ICSD-3) no longer separates insomnia disorders into discrete diagnostic categories [2]. Rather, they are all included under the terms "chronic insomnia disorder," "short-term insomnia disorder," or "other insomnia disorder." However, for the purposes of evaluation and application of specific behavioral interventions in clinical practice, it is useful to consider the contributors to childhood insomnia in the following categories:
●Behavioral insomnia of childhood
•Related to sleep onset associations
•Related to inadequate limit-setting by parents
●Psychophysiologic (conditioned) insomnia
●Transient sleep disturbances
Behavioral insomnia of childhood — Behaviorally-based insomnia in children typically presents as bedtime resistance, prolonged sleep onset, or night wakings. These issues often coexist, and many children present with both bedtime delays and prolonged nighttime awakenings that require parental intervention. Behavioral insomnia is most common in young children aged zero to five years but may persist into middle childhood and beyond. The primary causes are either maladaptive sleep onset associations, parental difficulties with limit-setting, or both.
Some degree of bedtime resistance or insomnia is common in children and is often transient. To be considered a sleep disorder, the symptoms must occur at least three times per week, persist for at least three months, and result in significant impairment of functioning in the child, parent(s), or family [2].
Insomnia related to sleep onset associations — The presenting problem in this type of behavioral insomnia is generally one of prolonged night waking that often results in insufficient sleep. In this disorder, the infant or child has learned to fall asleep only under certain conditions or has specific sleep associations that typically require parental intervention, such as being rocked or fed, which are usually readily available at bedtime. During the night, when the child experiences the type of brief arousal that normally occurs at the end of each 60- to 90-minute sleep cycle, or awakens for other reasons, he/she is not able to get back to sleep ("self-soothe") unless those same conditions are available. The child then "signals" the caregiver by crying (or coming into the parents' bedroom if the child is no longer in a crib) until the necessary associations are provided.
This problem can be avoided or attenuated by the practice of putting the infant or child to bed while drowsy but still awake, starting at approximately three months of age. This practice avoids creation of an association between sleep onset and being held or rocked.
Insomnia related to inadequate parental limit-setting — The limit-setting type of behavioral insomnia is most common in children preschool-aged and older. It is characterized by active resistance, verbal protests, and repeated demands at bedtime ("curtain calls") rather than night wakings. If sufficiently prolonged, the sleep onset delay may result in inadequate sleep. Some children present with nighttime fears characterized by fearful behaviors (eg, crying, clinging, or leaving the bedroom to seek parental reassurance), but these are a manifestation of bedtime stalling rather than anxiety.
This disorder most commonly develops from a caregiver's inability or unwillingness to set consistent bedtime rules and enforce a regular bedtime. The problem is often exacerbated by the child's oppositional behavior. In some cases, however, the child's resistance at bedtime reflects an underlying problem in falling asleep caused by other factors such as asthma, medication use, or other medical conditions; a sleep disorder, such as restless legs syndrome or anxiety; or a mismatch between the child's intrinsic circadian preferences ("night owl") and parental expectations.
Insomnia related to excessive "time in bed" — Although not a "formal" subtype of insomnia, this concept (which is largely credited to Dr. Richard Ferber) is very useful in clinical practice. Basically, these are children whose parent-set time in bed exceeds their sleep needs, resulting in prolonged bedtime struggles, night wakings, or early morning awakening (or some combination of all three). A schematic representation of a child whose sleep requirement of 10 hours is exceeded by a 12-hour expected time in bed is illustrated in the figure (figure 1). The solution is to reduce the "sleep window" to match sleep needs (in this case, 10 hours), typically by delaying bedtime and/or advancing wake time. This can be done incrementally, eg, delaying bedtime by 15 minutes every few nights until the target sleep window is achieved.
Psychophysiologic (conditioned) insomnia — Psychophysiologic (also sometimes termed "conditioned") insomnia may interfere with sleep onset or maintenance in the pediatric population, primarily in older children and adolescents. It is characterized by anxiety specifically about falling or staying asleep due to heightened physiologic and emotional arousal related to sleep and the sleep environment. Affected children often have maladaptive cognitions about the consequences of their sleep problems that further compromise their ability to sleep. (See "Risk factors, comorbidities, and consequences of insomnia in adults".)
This type of insomnia frequently arises from a combination of predisposing factors that may include genetic vulnerability, medical disorders, or psychiatric conditions. Precipitating factors may include acute stress, and perpetuating factors may include poor sleep habits, caffeine use, or inappropriate daytime napping. (See 'Psychophysiologic (conditioned) insomnia' below and "COVID-19: Management in children", section on 'Addressing or mitigating indirect effects of the pandemic'.)
Transient sleep disturbances — Transient sleep disturbances can occur in a child with previously normal sleep. A period of night wakings, for example, can be the result of a stressful life event and is usually self-limited. Disruption of sleep schedule while travelling can cause jet lag. Many illnesses also can disturb sleep. Such short-term sleep disturbances, however, can become chronic if parents respond in a way that reinforces the night wakings and fosters inappropriate sleep habits.
EPIDEMIOLOGY
Prevalence — Twenty to 30 percent of children in cross-sectional studies have significant bedtime problems or night waking, and in most cases, these have behavioral causes and solutions. The estimated prevalence of behavioral sleep disturbances in children is remarkably similar across studies, despite some variation in the definitions used.
Behavioral sleep problems are found in all age groups:
●Infants and toddlers – Night wakings are one of the most common sleep problems in infants and toddlers; 25 to 50 percent of children over the age of six months continue to awaken during the night [3]. Bedtime resistance is found in 10 to 15 percent of toddlers.
●Preschool-aged children – Up to 20 percent of preschool- and early school-aged children have insomnia symptoms, with an increased risk for those with comorbid medical conditions [4].
●Middle childhood – Although previously thought to be less common in middle childhood, more recent surveys suggest that insomnia symptoms are present in 20 to 40 percent of school-aged children [5], are persistent in a substantial percentage, and appear more common in girls than boys (at age 11 to 12 years) [6]. Consistent with previous studies, difficulty falling asleep was the most common insomnia complaint.
●Adolescents – Studies have estimated that 11 percent of adolescents (13 to 16 years of age) have a history of significant insomnia [7]. Children with neurodevelopmental (ie, autism, intellectual disability) and psychiatric disorders (ie, depression, anxiety, attention deficit hyperactivity disorder [ADHD]) are at particularly high risk for sleep disturbances.
Intrinsic versus extrinsic factors — Childhood insomnia involves intrinsic factors (those that are inborn or unique to the child and predispose to sleep problems) as well as extrinsic factors (environmental stimuli or caregivers' response) that precipitate or perpetuate the problem:
●Intrinsic factors that predispose or contribute to sleep problems include the child's temperament, medical issues, circadian preferences ("night owl" versus "morning lark"), neurodevelopmental disabilities, or anxiety disorders. Studies have also suggested that hyperarousal may be linked to the development of insomnia, as it is in adults [8], and genetics may also play a role as a predisposing factor [9].
●Extrinsic factors include characteristics of the parents or caregivers that interfere with their ability to set clear limits both during the day and at bedtime. These factors can include mental illness, emotional stress, distraction by other responsibilities, or long work hours. In other cases, a "mismatch" arises between parental expectations for sleep behaviors and the normal developmental trajectory. Finally, environmental factors may contribute to poor limit-setting or negative sleep onset associations. Examples include living accommodations that require a child to share a bedroom with a sibling, parent, or additional family members (eg, grandparents) residing in the home. In particular, early adverse experiences, including exposure to domestic violence or parental mental health problems, can set off a cascade of biologic stress responses that give rise to disruptions in the quality and quantity of sleep [10]. Other risk factors for significant sleep problems include racial and ethnic health disparities and factors related to living in poverty [11,12]. Extrinsic factors may predispose to, precipitate, or perpetuate the sleep problem [13].
In many cases, a sleep problem represents a combination of intrinsic and extrinsic factors. For example, "fussy" children may insist on a particular type of soothing/sleep-inducing technique, resisting any alternative that is less dependent on the caregiver [14]. When responding to the behavior, inexperienced parents may inadvertently increase the undesired behavior (ie, crying or getting out of bed) by providing attention and reinforcement, instead of ignoring the behavior and, thereby, reducing its likelihood.
The contributions from intrinsic and extrinsic factors were illustrated in a cohort study of twins (average age 16 months) that estimated that approximately 26 percent of the variance in sleep duration was attributable to genetic effects and 66 percent to shared environmental effects [15]. A separate longitudinal study in twin pairs suggested that daytime sleep duration was markedly influenced by environmental factors, whereas nighttime sleep duration was largely influenced by genetic factors [16]. However, there was also an important period around 18 months of age during which environmental influences had an important effect on nighttime sleep at later ages.
EVALUATION — The sleep history may be facilitated by the use of a screening tool, such as the BEARS survey, which a clinician uses to inquire about five sleep areas (Bedtime issues, Excessive daytime sleepiness, night Awakenings, Regularity and duration of sleep, and Snoring) (table 1).
If the primary problem is either bedtime resistance or difficulty initiating or maintaining sleep (sleeplessness or insomnia), behavioral origins are likely. Further evaluation is needed to identify potential contributors and solutions. The history includes a detailed description of the sleep problem(s), including timing of onset, parental response to the problem, and potential psychosocial contributors that may have triggered or perpetuated the problem (table 2). A sleep diary or log may be very helpful in delineating the timing and nature of the problem (form 1). The detailed history is summarized in the table and discussed further in a separate topic review. (See "Assessment of sleep disorders in children", section on 'Difficulty initiating or maintaining sleep'.)
The interpretation of the sleep history can be challenging for a number of reasons. First, the patient is rarely the one who presents with a chief complaint of sleeplessness. Thus, parental concerns and subjective observations regarding their child's sleep patterns and behaviors often define sleep disturbances in the clinical context. Second, sleep problems in the pediatric population must be viewed against a background of the normal developmental trajectory across childhood and developmental norms. "Normal" bedtime behavior, time to sleep onset, and sleep duration are dramatically different in children of different ages. Finally, cultural differences in sleep practices (eg, sleeping space and environment, solitary sleep versus cosleeping) have a profound effect on how a parent defines a sleep "problem" and also on the relative acceptability of various treatment strategies. Thus, the clinician must interpret the sleep history within the context of the individual child and family; the interpretation and solutions may also evolve depending on the response by child and family to behavioral interventions.
YOUNG CHILDREN WITH BEHAVIORAL INSOMNIA — Behavioral interventions are the mainstay of treatment for behavioral insomnia of childhood, which presents as bedtime resistance, prolonged sleep onset, or night wakings. The best established interventions use one or more of the following techniques:
●Bedtime routines
●Systematic ignoring (or "extinction") and its variants
●Bedtime fading
●Positive reinforcement
The efficacy of behavioral interventions has been shown in many studies, which typically involved education and support to the parents in applying one or several of the above techniques. As an example, a review of 52 treatment studies concluded that behavioral therapies produce reliable and durable changes for both bedtime resistance and night wakings in young children [17,18]. Ninety-four percent of the studies reported that behavioral interventions were effective. More than 80 percent of treated children demonstrated clinically significant improvement that was maintained at short- (<6 months), intermediate- (6 to 12 months), and long-range follow-up (>12 months). No study reported detrimental effects. A number of studies also found positive effects of sleep interventions on secondary child-related outcome variables, including daytime behavior (eg, crying, irritability, detachment, self-esteem, or emotional well-being). Sleep-related behavioral intervention also led to improvement in the well-being of the parents, with effects on mood, stress, or marital satisfaction in a number of studies [19].
Two studies specifically examined effects of behavioral interventions on child development and found no adverse effects. In a randomized study in infants, behavioral interventions (graduated extinction and bedtime fading) had no adverse stress responses in the infant (measured by salivary cortisol) or effects on parent-child attachment one year later [20]. Similarly, a study examining behavioral interventions in infants found no evidence of negative effect on child mental health, sleep, psychosocial functioning and stress regulation, child-parent relationship, and maternal mental health and parenting styles, measured when the child was six years old [21].
General guidance to parents — When initiating a behavioral strategy, it is important to give the parents general guidance about healthy sleep habits and behavioral principles [22].
●General education for all parents on establishing healthy sleep habits (table 3):
•Understand appropriate sleep times for children in each age group (table 4) [23,24] (see "Assessment of sleep disorders in children", section on 'Insufficient sleep')
•Establish a consistent bedtime for the child
•Establish a pre-bedtime routine that does not include stimulating activities or electronic media (eg, television viewing)
•Establish a routine in which the parent is not in the room when the child falls asleep
●Areas warranting particular emphasis for parents who are having difficulty setting limits:
•Avoid giving attention to the child for bedtime-delaying behavior
•Be consistent in applying behavioral programs to avoid intermittent reinforcement of undesired behaviors
•Expect that the child's protest behavior is likely to escalate temporarily at the beginning of treatment (this is known as a "post-extinction burst")
Specific techniques
Bedtime routines — Establishment of a consistent bedtime routine is helpful for all manifestations of behavioral insomnia (bedtime resistance, prolonged sleep onset, and night wakings) [13]. The routine should last approximately 20 to 45 minutes and include three to four soothing activities, such as taking a bath, changing into pajamas, and reading stories; it should not include television or other electronic devices [25-29]. The introduction at bedtime of more appropriate sleep associations should be readily available to the child during the night and can include transitional objects such as a blanket or toy. The child should be put to bed drowsy but awake to minimize dependence upon parental presence at sleep onset.
An integral part of the bedtime routine is the institution of a bedtime and sleep schedule that ensures a developmentally appropriate amount of sleep. The bedtime should coincide with the child's natural sleep onset time. A consistent nightly bedtime will help to reinforce the circadian clock and enable the child to fall asleep more easily.
Systematic ignoring — Systematic ignoring addresses problems at sleep onset or night waking in which the child needs or demands a parent's assistance. Typically, this occurs when the child demands that the parent stay in the room while he or she falls asleep or when the child wakes the parent for reassurance during the night. The technique typically involves a program of abrupt or gradual withdrawal of parental assistance at sleep onset and during the night. When consistently applied, systematic ignoring usually achieves "extinction" of the need for parental assistance.
●Unmodified extinction ("crying it out") involves putting the child to bed at a designated bedtime and then ignoring the child until a set time the next morning. Although this approach has been documented to be a highly successful treatment, it is often not acceptable to families; parents are often unable to tolerate the child's crying and protest behavior and are less likely to be compliant.
●Graduated extinction is an alternative approach that weans the child from dependence upon parental presence; it involves putting the child to bed drowsy but awake and waiting progressively longer periods of time before checking on the child. On each subsequent night, the initial waiting period before checking is increased by a specified number of minutes. When parents check on their child, they should reassure the child but keep contact brief (one to two minutes) and neutral (eg, pat on shoulder rather than pick up and cuddle). Since the goal of this treatment is to allow the child to fall asleep independently, there is no recommended "optimal" period of time between checks, and the amount of time should be determined by the parents' tolerance for crying and the child's temperament.
A variation on this approach, especially with somewhat older children (preschool-aged and up), is to use positive reinforcement. For example, the caregiver should try to return to the child's bedroom only when he/she is engaged in more appropriate behavior such as remaining in bed instead of climbing out. Another option is to close the child's bedroom door until more appropriate behavior occurs. As an example, a child who becomes more agitated with brief parental checks may do better with infrequent checks.
Graduated extinction is effective even if instituted only at bedtime. Within one to two weeks after the child has learned to fall asleep easily and quickly at bedtime, the self-soothing skills usually generalize to nighttime arousals.
In order to develop a strategy that gradually eliminates adult intervention, the clinician and parents should collaborate to develop a specific plan. They should identify an end goal, such as falling asleep independently at bedtime, and outline successive steps to achieve that goal. For example, a plan might include three days of establishing a bedtime routine and target bedtime, three nights of the parent sitting with the child at the bedside until the child falls asleep, three nights of sitting in the child's bedroom doorway, followed by three nights of sitting outside of the doorway.
More gradual fading of adult intervention may be more appropriate for families that either are unable to tolerate the above extinction approaches or consider them unacceptable.
Bedtime fading — Bedtime fading addresses problems with insomnia at sleep onset, which may be related to a natural "evening" circadian preference with a resulting "mismatch" between the set bedtime and the child's fall asleep time. The technique involves temporarily setting the bedtime to the current sleep onset time and then gradually advancing the time of lights out [30]. The initial bedtime is set to coincide with the natural sleep onset time when the child is more physiologically ready for sleep, and the circadian preference is then gradually modified by setting the bedtime earlier over a period of several weeks.
Bedtime fading may also be used to address a common situation in which the child's "time in bed" exceeds his/her sleep needs (eg, when a parent establishes a set sleep schedule of 12 hours, conflicting with a sleep need of only 10 hours). This results in difficulty falling asleep, prolonged night wakings, or early morning waking. Setting a later bedtime, which provides a "sleep window" that approximates sleep needs, often eliminates the problem.
Strategic napping — Napping schedules should take into consideration normal developmental daytime sleep patterns, 24-hour sleep needs (nocturnal plus daytime sleep), and sleep drive. Children typically need at least four hours between sleep periods in order to build up enough of a sleep drive to allow them to fall asleep again. Thus, naps that are too close together, too long in duration in relation to nighttime sleep, or too late in the day can result in insomnia complaints.
Positive reinforcement — Reinforcement strategies, such as sticker charts, can be beneficial with preschoolers and older children. Such systems are most effective if rewards can be earned immediately. For example, the sticker reward should be given first thing in the morning if the child has met the goal. In addition, the goals must be obtainable to reinforce success. For example, a child may initially earn a sticker just for sleeping in his/her own bed all night, even in the face of frequent calls to parents. With time, more challenging goals can be implemented.
For school-aged children, the rewards can be modified as appropriate to the child's interests, but they should still be concrete and immediate. Multiple small rewards are generally more effective than fewer larger rewards.
OLDER CHILDREN AND ADOLESCENTS — In older school-aged children and adolescents, insomnia typically is "conditioned" (perpetuated by anxiety around difficulty falling or staying asleep, which may be the first presenting symptom of a more generalized anxiety disorder), circadian rhythm disturbance, or a combination of these factors. These issues are appropriately addressed by education and support to establish healthy sleep habits, as outlined below. Cognitive behavioral therapy for insomnia is a promising strategy for treating older children and adolescents with insomnia [31], including in online formats [32].
Psychophysiologic (conditioned) insomnia — Treatment of insomnia in older children and adolescents usually involves similar behavioral interventions as are used in adults. (See "Cognitive behavioral therapy for insomnia in adults".)
Established strategies include the following:
●Education of the child or adolescent about principles of healthy sleep practices (table 3 and table 5), particularly emphasizing:
•Keep a regular sleep-wake schedule, and do not "sleep in" on weekends.
•Avoid use of electronic devices with light-emitting screens, including laptop computers, gaming systems, and smartphones, for at least one hour before lights out; this strategy can increase sleep time and improve daytime functioning [33]. Keeping these devices out of the bedroom, especially during the night, is strongly recommended. (See "Assessment of sleep disorders in children", section on 'Behavioral contributors'.)
●Instruction of the child or adolescent to use the bed for sleep only and to get out of bed if unable to fall asleep (stimulus control).
●Restriction of time in bed to the actual time asleep (sleep restriction).
●Use of relaxation techniques and cognitive-behavioral strategies to reduce anxiety.
Strategies to address the effects of the disruptions caused by the coronavirus disease 2019 (COVID-19) epidemic on anxiety and sleep in children are discussed separately. (See "COVID-19: Management in children".)
Delayed sleep-wake phase disorder — Adolescents who present with the complaint of sleep onset insomnia (difficulty initiating sleep at the targeted time) often have a circadian rhythm disturbance known as delayed sleep-wake phase disorder, previously known as delayed sleep phase syndrome [2]. Teenagers and young adults often develop a circadian rhythm that is slightly longer than 24 hours, which results in a circadian-mediated shift (delay) in sleep and wake time relative to the patient's desired or required sleep schedule. When sufficiently severe, delayed sleep-wake phase disorder can emerge. Affected individuals often report significant difficulty falling asleep and difficulty waking up on time for morning classes. However, patients have much less difficulty with sleep onset and waking up when allowed to sleep on their preferred schedule (ie, on weekends or during vacations).
Interventions for this type of circadian rhythm disturbance include the healthy sleep strategies outlined in the table (table 5) and, especially, regular bedtimes and wake times. Additional strategies are often needed initially to reestablish targeted bedtimes and rise times and sometimes to maintain them. These more specific interventions are outlined in a separate topic review (see "Delayed sleep-wake phase disorder"). Melatonin, taken several hours before bedtime, is not regulated or approved by the US Food and Drug Administration but may also, in some circumstances, help to realign the circadian rhythm in severe delayed sleep-wake phase disorder.
INDICATIONS FOR REFERRAL — Reasons to consider referral to a sleep medicine behavioral specialist or pediatric sleep clinic include:
●Inadequate response in the child or failure of adherence by caregivers to the behavioral interventions described above
●Insomnia in patients with medical, psychiatric, or neurodevelopmental comorbidities
●Insomnia accompanied by significant daytime sleepiness
●Safety concerns (parental depression, stress, possible physical abuse)
●Consideration of prescription medication
●Suspected additional sleep diagnoses, such as sleep-related breathing disorders, restless legs syndrome, or circadian-based disorders
PHARMACOLOGIC INTERVENTIONS — The vast majority of sleep disturbances in children are successfully managed with behavioral therapy alone. Medication should be considered only when appropriately implemented behavioral interventions are not effective, and medication should always be combined with behavioral therapy [34].
●Indications – It is reasonable to consider pharmacotherapy as an adjunct to behavioral therapy in the following situations:
•Children with medical or psychiatric disorders or with neurodevelopmental disorders, such as attention deficit hyperactivity disorder (ADHD) or autism [35]. These populations tend to have more severe or chronic sleep problems that may not respond to behavioral interventions alone.
•Children with insomnia who are typically developing and otherwise healthy, if behavioral strategies alone have been persistently unsuccessful or if the sleep problem is at a level of severity that results in significant family disruption or potentially poses safety risks. For a variety of reasons, caregivers may be unable to successfully implement behavioral strategies due to lack of resources or other issues such as comorbid mental or physical health concerns. In general, a trial of a behavioral intervention plan should be performed before considering adding medication; the behavioral intervention should be trialed for at least four weeks, with at least one follow-up visit to implement any necessary modifications. In rare cases, it may be appropriate to start medication at the outset (eg, when a family is in crisis), in which case, the medication helps to diffuse the situation, provides some relief for exhausted caregivers, and allows them to focus on instituting behavioral therapies.
●Selection of medications – If medication is thought to be potentially beneficial in a given clinical situation, the following guidelines should be kept in mind [34]:
•There are no medications labeled specifically for use for insomnia in children by the US Food and Drug Administration. The array of medications that are prescribed in clinical practice for childhood sleep disturbances appears to be based largely on clinical experience, empirical data derived from adults, or small case series of medication use.
•The choice of medication for any child with a sleep disorder should be guided by the presenting sleep problem. For example, agents with an immediate onset of action and short half-life are generally used for sleep onset insomnia. Medications with a longer half-life and duration of action may be needed for difficulties with maintenance of sleep but may result in morning "hangover," daytime sleepiness, and compromised daytime functioning.
•Melatonin, a synthetic form of the hormone produced by the pineal gland as a biomarker of the circadian system, is a commonly used nonprescription pharmacologic treatment for insomnia in children and may be particularly appropriate for those with sleep disturbance due to circadian phase delay. Studies suggest it is somewhat efficacious and generally well tolerated, both in special pediatric populations (children with ADHD [36] or autism [35,37]) as well as typically-developing children [38]. In general, there is a larger evidence base to support the use of melatonin to address sleep initiation insomnia in children and relatively little evidence that it has beneficial effects on sleep maintenance insomnia [39]. While no significant long-term adverse effects have been identified, this is based on limited evidence. Of note, one study of over-the-counter melatonin preparations found considerable variability in actual melatonin content, and more than 25 percent of the samples analyzed contained serotonin, a melatonin precursor [40]. (See "Pharmacotherapy for insomnia in children and adolescents: A rational approach", section on 'Melatonin'.)
•Over-the-counter antihistamines such as diphenhydramine are commonly used as sedatives in pediatric practice. These medications may be useful in acute situations (sleeplessness related to travel, illness). However, they are rarely appropriate for managing a chronic sleep problem because tolerance tends to develop, requiring escalating doses.
•While a discussion of specific hypnotic medications is beyond the scope of this topic, more recent reviews may be helpful in guiding the clinician [41]. Because there have been very few randomized clinical trials and there are no medications approved by the US Food and Drug Administration for use for insomnia in children, empirical evidence is lacking to create a "hierarchy" of sedative/hypnotic drugs for potential off-label use in children.
The use of these drugs for insomnia in children is discussed in a separate topic review, including a list of pros and cons for each drug; this is largely based on clinical experience since evidence from clinical trials is scant. (See "Pharmacotherapy for insomnia in children and adolescents: A rational approach".)
An overview of pharmacotherapy for sleep in children with neurologic and neurodevelopmental disorders is presented separately. In general, pharmacotherapy should be managed by or in consultation with a specialist in pediatric sleep disorders or neurodevelopmental disabilities. (See "Medical disorders resulting in problem sleeplessness in children", section on 'Neurologic and neurodevelopmental disorders'.)
SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Insomnia in children".)
SUMMARY AND RECOMMENDATIONS
●Sleep problems with behavioral origins occur in 20 to 30 percent of children and are especially common in children with medical, neurodevelopmental, or psychiatric disorders. (See 'Prevalence' above.)
●Insomnia related to learned sleep onset associations is most common in infants and toddlers and is characterized by prolonged night waking, requiring parental intervention to restore sleep. It occurs when the child learns to associate falling asleep with specific experiences, such as being rocked or fed. (See 'Insomnia related to sleep onset associations' above.)
●Insomnia related to inadequate limit-setting is a disorder most common in children who are preschool-aged and older and is characterized by active resistance, verbal protests, and repeated demands at bedtime. This disorder most commonly develops from a caregiver's inability or unwillingness to set consistent bedtime rules and enforce a regular bedtime. (See 'Insomnia related to inadequate parental limit-setting' above.)
●Guidance to parents about healthy sleep practices (table 3) helps to prevent sleep problems and is also an important first step in treatment. Behavioral intervention strategies, including bedtime routines, systematic ignoring, bedtime fading, and positive reinforcement are highly effective in treating behavioral insomnias in children. (See 'Young children with behavioral insomnia' above.)
●An integral part of the bedtime routine is the institution of a bedtime and sleep schedule that ensures a developmentally appropriate amount of sleep (table 4). A consistent nightly bedtime will help to set the circadian clock and enable the child to fall asleep more easily. (See 'Bedtime routines' above.)
●Treatment of primary insomnia in older children and adolescents usually involves behavioral interventions that resemble those used in adults. Establishing a consistent sleep schedule is also important for older children and adolescents for whom poor sleep hygiene is a common cause of sleep problems (table 5). (See 'Older children and adolescents' above and "Cognitive behavioral therapy for insomnia in adults".)
●Pharmacologic therapy for the treatment of childhood insomnia is not a first-line treatment and should always be combined with behavioral therapy. (See 'Pharmacologic interventions' above.)
