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REVIEW ARTICLES

The Use of Pharmacotherapy in the Treatment of Pediatric Insomnia in Primary

Care: Rational Approaches. A Consensus Meeting Summary
Judith A. Owens M.D., M.P.H.1; Deborah Babcock, M.D.2; Jeffrey Blumer, M.D.3; Ronald Chervin, M.D.4; Richard Ferber, M.D.5; Mark Goetting, M.D.6; Daniel Glaze,
M.D.7; Anna Ivanenko, M.D.8; Jodi Mindell, Ph.D9; Marsha Rappley, M.D.10; Carol Rosen, M.D.3; Stephen Sheldon, D.O.11

1Brown Medical School and Hasbro Children’s Hospital, Providence, RI; 2Altos Pediatric Associates, Los Altos, CA; 3 Case School of Medicine and
Rainbow Babies and Children’s Hospital, Cleveland, OH; 4University of Michigan Medical School, Ann Arbor, MI; 5Harvard Medical School,
Boston, MA; 6Kalamazoo Neurology, Kalamazoo, MI; 7Baylor College of Medicine, Houston, TX; 8Loyola University Medical Center, Maywood,
IL; 9St. Joseph’s University and Children’s Hospital of Philadelphia, Philadelphia, PA; 10Michigan State University Medical School, East Lansing,
MI and American Academy of Pediatrics, Elk Grove Village, IL; 11Northwestern University, Feinberg School of Medicine, Chicago, IL
Objectives: To formulate a rational approach to the pharmacologic treat- ulations and future directions.
ment of pediatric insomnia, and to develop clinical guidelines regarding indi- Conclusions: Use of medications for pediatric insomnia should be diagnosti-
cations, target populations, and parameters for the use of these medica- cally driven, and should be implemented in conjunction with empirically-based
tions, especially by community-based pediatricians. behavioral treatment strategies and adequate sleep hygiene. Specific target
Participants: A multidisciplinary task force developed under the auspices of populations include children with neurodevelopmental disorders, pervasive
the American Academy of Sleep Medicine, which included experts in pediatric developmental disorders, chronic medical conditions, and psychiatric disorders.
sleep medicine, psychiatry, pharmacology, neurology, and general pediatrics. Additional research, including clinical trials, is critically needed to provide an
Evidence: Review of existing data regarding current use of over-the-counter evidence-based approach to the use of these medications in clinical practice.
and prescription medications for pediatric insomnia in the primary care practice Key Words: Pediatric, Insomnia, Pharmacotherapy.
setting, and of empirical data on the pharmacology, safety, efficacy, and tolera- Citation: Owens JA; Andreason P; Babcock D et al. The use of pharma-
bility of medications commonly used for the treatment of pediatric insomnia cotherapy in the treatment of pediatric insomnia in primary care; rational
Consensus Process: Group consensus definition of pediatric insomnia and approaches. A consensus meeting summary. J Clin Sleep Med
clinical guidelines; working group recommendations regarding special pop- 2005;1(1):49-59

R ecent studies suggest that medications for sleep problems are

part of the increasing use of psychopharmacotherapy in chil-
dren.1-3 Several survey studies of European physicians in clinical
practice which included questions about the use of prescription
and nonprescription medications specifically for sleep problems
in children, have found that one of the primary indications for
Disclosure Statement
This is a report of a task force supported by the American Academy of Sleep
Medicine. Dr. Owens has received research support from Johnson & Johnson,
Cephalon, Sanofi-Synthelabo and Eli Lilly; has participated in speaking engagements
supported by Johnson & Johnson and Eli Lilly; serves as an Advisory Board Member
for Eli Lilly and Cephalon and has received consulting fees from Sanofi-Synthelabo
and Sepracor. Dr. Blumer is a PI of multi-center trial supported by Sanofi-Synthelabo.
Dr. Glaze has received research support from Sanofi-Synthelabo. Dr. Sheldon is a PI
of a clinical trial supported by Cephalon, Inc. Dr. Mindell has received research sup-
port from Sanofi-Synthelabo; has participated in speaking engagements supported by
King Pharmaceuticals and Johnson & Johnson; and serves on the Advisory Board for
Johnson’s Baby. Dr. Rosen has received research support from Sanofi-Synthelabo.
Drs. Goetting, Ivanenko, Chervin, Babcock, Ferber, and Rappley have indicated no
financial conflicts of interest.
Submitted for publication October 2004
Accepted for publication November 2004
Address correspondence to: Judith A. Owens, MD, MPH, Division of Pediatric
Ambulatory Medicine, Rhode Island Hospital, 593 Eddy St., Potter Bldg., Suite
200, Providence, RI 02903; Tel: (401) 444-8280; Fax: (401) 444-6218; E-mail:
Owensleep@aol.com
psychotropic use in children is sleep disturbances.4-9 Although
little data on the use of soporific medications in the pediatric pop-
ulation in the United States exist, several lines of evidence sug-
gest that this may be a common practice in the United States as
well. For example, recent data from a national survey of 670
community-based pediatricians10 found that about 75% of practi-
tioners had recommended nonprescription medications and more
than 50% had prescribed a sleep medication for children with
sleep problems in the previous 6 months. Although there were a
number of special clinical circumstances in which medications
were reported to be more commonly used, including children
with special needs such as mental retardation, autism, and atten-
tion-deficit hyperactivity disorder, almost 40% of the respon-
dents in the survey reported recommending medication for oth-
erwise normal children with significant difficulty falling or stay-
ing asleep and “bedtime struggles/sleep-onset delay.”
Antihistamines were the most commonly recommended nonpre-
scription medication (68%) and α-receptor agonists were the
most frequently prescribed sleep medications (31%); approxi-
mately 15% had prescribed an antidepressant for adolescent
insomnia. In another recent study11 examining sleep medication
prescriptions in a 39-month period for over 38,000 Medicaid
recipients in Michigan, 20% of the children had received at least
1 dose of a sleep medication; many of these children were from
special needs populations. Furthermore, there was a wide varia-
tion in prescribing practices by county and by individual practi-
tioner.

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JA Owens, D Babcock, J Blumer et al
Unlike the solid body of evidence that exists for empirically
supported nonpharmacologic or behavioral treatments for pedi-
atric insomnia,12 there are relatively few empirical data to support
the use of many of the more commonly used over-the-counter
and prescription medications in the pediatric population, such as
prescription and nonprescription antihistamines, chloral hydrate,
α-receptor agonists such as clonidine, melatonin, and antidepres-
sants. As a result, sound clinical practice at all levels is compro-
mised by the fact that there remains a significant lack of knowl-
edge concerning the efficacy, tolerability, and safety profiles of
soporific drugs in children. Indeed, a recent survey study of sleep
knowledge among pediatricians13 suggests that at least some of
these medications are prescribed by practitioners in the commu-
nity not only frequently, but often inappropriately (eg, antihis-
tamines for sleep terrors and melatonin for adolescents with poor
sleep hygiene). Furthermore, the dramatic increase seen recently
in clonidine overdose in pediatric patients14 between 1990 and
1997 may be at least a partial reflection of inappropriately pre-
scribed sedative and hypnotic drugs.
Despite the lack of empirical supporting data, the development
of a rational approach to the use of pediatric sleep medications,
especially for the practicing pediatrician, is an important, timely,
and appropriate task due to the widespread use of these medica-
tions in clinical practice, and the apparent need for safe and effec-
tive medications for some high-risk populations in particular.
Recognizing this need, in March of 2003, the American Academy
of Sleep Medicine established a multidisciplinary task force on
Pharmacotherapy in Pediatric Sleep Medicine with the following
charge: to develop a set of clinical experience-based general
guidelines for primary care physicians regarding the use of medi-
cation as an adjunct in the treatment of pediatric insomnia and to
develop a set of indications, target populations, and parameters for
the use of these medications, based on the information that is cur-
rently available.
In addition, it was felt that the establishment of the task force
would provide an opportunity to educate pediatricians about the
diagnosis and management of sleep disorders in children. Finally,
in order to help generate the data that are needed to eventually
develop standards of practice for the use of these pharmacologic
agents, an additional charge to the task force was to develop rec-
ommendations for and to advocate further research in this area.
The task force consisted of a panel of 13 experts in the fields
of pediatric sleep medicine, psychiatry, neurology, developmen-
tal/behavioral pediatrics, pharmacology, and community-based
pediatrics, as well as representatives from the American
Academy of Pediatrics and the Food and Drug Administration.
The task force met over a 2-day period to review the empirical
data regarding the use of medications for pediatric insomnia, as
well as the literature on current clinical practices. Three working
groups (General Clinical Guidelines, Special Populations, and
Research Recommendations) then convened to develop the sum-
mary recommendations presented below.
SUMMARY OF RECOMMENDATIONS
In order for the pediatric practitioner to develop a rational and
diagnostically driven approach regarding the use of pharmacother-
apy in the treatment of pediatric sleep problems, the task force
agreed that it was important to first outline the clinical context in
which these problems are likely to appear, including the definition
Journal of Clinical Sleep Medicine, Vol. 1, No. 1, 2005
of insomnia and the scope of the problem in clinical practice, and to
emphasize both the importance of screening for sleep problems and
of conducting a thorough diagnostic evaluation prior to treatment.
Consensus Definition of Pediatric Insomnia
Insomnia is a symptom and not a diagnosis. The causes of
insomnia are varied and range from the medical (ie, drug-related,
pain-induced, associated with primary sleep disorders such as
obstructive sleep apnea) to the behavioral (ie, associated with
poor sleep hygiene or sleep-onset association disorder) and are
often a combination of these factors. In adults, insomnia is gen-
erally defined as difficulty initiating and/or maintaining sleep
and/or early morning awakening and/or nonrestorative sleep.15
However, the definition of insomnia or problematic sleep in chil-
dren is much more challenging for a number of reasons.
Clinically significant sleep problems, like many behavioral prob-
lems in childhood, may best be viewed as more loosely occurring
along a severity and chronicity continuum that ranges from a
transient and self-limited disturbance to a disorder that meets
specific diagnostic criteria. Unlike strict research definitions of
sleep problems, the validity of parental concerns and opinions
regarding their child’s sleep patterns and behaviors and the
resulting stress on the family must be considered in defining
sleep disturbances in the clinical context. The relative prevalence
and the various types of sleep problems that occur throughout
childhood must also be understood in the context of normal phys-
ical, cognitive, and emotional phenomena that are occurring at
different developmental stages. Parental recognition and report-
ing of sleep problems in children also varies across cultures and
across age groups, with parents of infants and toddlers more like-
ly to be aware of sleep concerns than those of school-aged chil-
dren and adolescents. Thus, the range of sleep behaviors that may
be considered “normal” or “pathologic” is wide, and the defini-
tions are often highly subjective.
In order to more clearly define the clinical situations in which
the use of pharmacotherapy for pediatric sleep problems might be
appropriate, the task force members agreed that the development
of a consensus definition of pediatric insomnia was a necessary
and important first step. It should be noted that, in most instances,
the standard adult definition of insomnia may be applied to ado-
lescents and that pediatric insomnia refers largely to children
under the age of 12 years. The key components of the consensus
definition developed by the panel were as follows:
Pediatric insomnia may be defined as difficulty initiating or
maintaining sleep that is viewed as a problem by the child or
caregiver.
The significance of the sleep problem may be characterized by
its severity, chronicity, and frequency and associated impairment
in daytime function in the child or family.
The sleep problem may be due to a primary sleep disorder or
occur in association with other sleep, medical, or psychiatric dis-
orders.
Scope and Impact of Pediatric Insomnia
The task force members emphasized the importance of under-
scoring the prevalence and impact of sleep problems in pediatric
clinical practice in order to provide a rationale for developing phar-
macologic treatment strategies. Although prevalence rates are at
50
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best approximations because the definition of difficulty initiating
or maintaining sleep in children varies across studies, approxi-
mately 25% of all children are reported to experience some type of
sleep problem at some point during childhood.16 Specific studies
have reported an overall prevalence of a variety of parent-reported
sleep problems ranging from 25% to 50% in preschool-aged sam-
ples,17 to 37% in a community sample of 4- to 10-year-olds,18 to
upward of 40% in adolescents.19 Furthermore, sleep concerns are
one of the most frequent parental complaints in pediatric practices,
reported as the fifth leading concern of parents, following illness,
feeding, behavior problems, and physical abnormalities.20
Although in many children these sleep disturbances are transient,
there is considerable evidence that sleep problems may persist or
recur in a substantial percentage.21,22 In addition to their high preva-
lence and chronicity, recent evidence also suggests that sleep disor-
ders may have significant short- and long-term consequences on
children’s academic and social functioning and on their health.23 A
wealth of empirical evidence from several lines of research clearly
indicates that children and adolescents experience significant day-
time sleepiness as a result of inadequate or disturbed sleep and that
significant performance impairments and mood dysfunction are
associated with that daytime sleepiness. Higher-level cognitive
functions, such as cognitive flexibility and the ability to reason and
think abstractly, appear to be particularly sensitive to the effects of
disturbed or insufficient sleep.23 Finally, health outcomes of inade-
quate sleep include an increase in accidental injuries (ranging from
minor injuries to drowsy driving-related motor vehicle fatalities)
and potential deleterious effects on the cardiovascular, immune, and
various metabolic systems, including glucose metabolism and
endocrine function.24,25 Sleep problems are also a significant source
of distress for families and may be one of the primary reasons for
caregiver stress in families with children who have chronic medical
illnesses or severe neurodevelopmental delays.
Screening for Sleep Problems
A number of studies have suggested that screening for sleep
problems in pediatric practice is inadequate and may result in sig-
nificant underdiagnosis of sleep disorders.26 For example, in the
recent survey of more than 600 community-based pediatricians
cited above,13 more than 20% of the respondents did not routine-
ly screen for sleep problems in school-aged children in the con-
text of the well-child visit, and fewer than 40% questioned ado-
lescents directly about their own sleep habits. Recognizing this
gap, the task force recommended that all children be regularly
screened for sleep problems in pediatric clinical practice. One
simple sleep-screening algorithm is the BEARS.27 The key areas
of inquiry that are included in the BEARS screening for sleep
problems in children and adolescents are (1) bedtime resistance
and delayed sleep onset; (2) excessive daytime sleepiness; (3)
awakenings during the night; (4) regularity, pattern, and duration
of sleep; and (5) snoring and other symptoms of sleep-disordered
breathing. A number of other brief parent and self-report sleep
survey tools have also been developed28-30 that can facilitate the
screening process and yield important information about the
nature and severity of any coexisting sleep complaints.
Evaluation of Sleep Complaints
The clinical evaluation of a child presenting with a sleep prob-
Journal of Clinical Sleep Medicine, Vol. 1, No. 1, 2005
Pharmacotherapy For Pediatric Insomnia
lem involves a careful medical history to assess for potential med-
ical causes of sleep disturbances, such as allergies, concomitant
medications, and acute or chronic pain conditions. A developmen-
tal history is important because of the aforementioned frequent
association of sleep problems with developmental delays.
Assessment of the child’s current level of functioning (school,
home, etc) is key in evaluating possible mood, behavioral, and
neurocognitive sequelae of sleep problems. Current sleep patterns,
including usual sleep duration and sleep-wake schedule, are often
best assessed with a sleep diary, in which parents record daily
sleep behaviors for an extended period. A review of sleep habits,
such as bedtime routines, daily caffeine intake, and the sleeping
environment (temperature, noise level, etc) may reveal environ-
mental factors that contribute to the sleep problems. Use of addi-
tional diagnostic tools such as polysomnographic evaluation are
seldom warranted for routine evaluation of pediatric insomnia but
may be appropriate if organic sleep disorders such as obstructive
sleep apnea or periodic limb movements are suspected.
Finally, referral to a sleep specialist for diagnosis, treatment, or
both diagnosis and treatment should be considered under the fol-
lowing circumstances: children or adolescents with persistent or
severe bedtime issues that are not responsive to simple behav-
ioral measures or that are extremely disruptive; children or ado-
lescents with parasomnias who also present with symptoms of
another underlying sleep disrupter (eg, sleep-disordered breath-
ing) or for whom pharmacologic treatment is being considered;
children with associated medical, psychiatric, or developmental
conditions that create additional management challenges; and
children and adolescents with circadian rhythm disorders.
MEDICATION GUIDELINES
Any discussion of the use of pharmacologic interventions in the
treatment of pediatric insomnia must be prefaced by a statement
regarding the importance of good sleep hygiene as a necessary
component of every treatment package. Sleep hygiene refers to the
basic environmental (eg, temperature, noise level, ambient light),
scheduling (eg, regular sleep-wake schedule), sleep practice (eg,
bedtime routine), and physiologic (eg, exercise, timing of meals,
caffeine use) factors that promote optimal sleep. Furthermore, it
should be emphasized that behavioral (ie, nonpharmacologic)
treatment approaches to bedtime struggles and night waking in
children have a well-documented empirical basis and are the main-
stay of treatment and that pharmacologic approaches should be
largely considered adjuncts in the treatment of pediatric insomnia.
Principles of sleep hygiene are listed in Table 1, and a list and brief
description of the most common behavioral treatments for pedi-
atric insomnia are included in Table 2.
CHARACTERISTICS OF THE “IDEAL” HYPNOTIC
Currently, there are no medications approved by the Food and
Drug Administration for the treatment of difficulty initiating or
maintaining sleep in the pediatric population. Although it is clear
that the ideal pediatric hypnotic medication does not exist, the
task force members agreed that it was important to consider char-
acteristics that would be present in the optimal clinical situation,
in order to allow the practitioner to compare the pharmacologic
options that are currently available. Pharmacokinetic properties
of the ideal pediatric hypnotic would include the high oral
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JA Owens, D Babcock, J Blumer et al

bioavailability, a property that encompasses solubility, rapid
absorption, stability, and invulnerability to extensive first-pass
metabolism by the liver or gut, in order to ensure rapid, consis-
tent, reliable clinical response and allow appropriate dosages to
be predicted accurately.46 Metabolism should be to inactive prod-
ucts or to active metabolites with short half-lives, with half-lives
no longer than that of the parent compound in order to minimize
metabolite-associated side effects. Elimination half-life should be
short (2 to 3 hours). Pharmacodynamic properties would include
a rapid onset of effect, preferably within 30 minutes, so that it
could be administered shortly before bedtime, and a duration of
action that would be sufficiently long so that only once-nightly
dosing is necessary but not excessively long so that it produces
residual daytime sedation. There should also be no associated
rebound, tolerance, or withdrawal and few side effects—prefer-
ably, the tolerability profile of placebo—with little or no poten-
tial for drug-drug interactions. The ideal hypnotic should also not
affect sleep architecture, as changes in slow-wave sleep, for
example, might lead to alterations in levels of hormones such as
human growth hormone. Finally, the medication should be avail-
able in a palatable oral liquid as well as tablet or capsule formu-
lation. Pharmacologic and clinical properties of medications cur-
rently most commonly used in the treatment of pediatric insom-
nia are listed in Tables 3 and 4.
It should also be noted that there are many herbal preparations
that are also used for the treatment of pediatric insomnia, both by
parents and practitioners. These include valerian, chamomile,
kava, lavender, and, less commonly, hops, lemon balm, and pas-
sion flower.51,52 In particular, valerian root and chamomile have
been shown in several studies to have sleep-promoting effects
without residual daytime drowsiness or performance impairment.
The long-term safety and efficacy of most herbal preparations are
unknown. Table 5 lists properties of selected commonly used
herbal preparations.
General Recommendations for Use of Medications in
Pediatric Insomnia
• Since the ideal pediatric hypnotic does not currently exist,
rational treatment selection should be based on the clinician’s
judgment of the best possible match between the clinical circum-
stances (type of sleep problem, patient characteristics, etc) and
the individual properties of currently available drugs (onset and
duration of action, safety, tolerability, etc). This principle pre-
sumes some degree of familiarity on the part of the clinician with
the pharmacologic profile of the sedative/hypnotics currently
available for use in the pediatric population.
• Treatment must be diagnostically driven and based on a care-
ful clinical evaluation of the symptoms and consideration of all
possible differential diagnoses. It is incumbent upon the clinician
to choose the most appropriate pharmacologic or behavioral ther-
apies, or a combination thereof, based on the actual diagnosis
rather than the symptom complex. For example, sleep-initiation
insomnia may be due to a primarily behavioral sleep disorder (eg,
limit-setting sleep disorder), a physiologically based sleep disor-
der (eg, restless legs syndrome, delayed sleep phase syndrome),
or a combination (eg, psychophysiologic insomnia), each neces-

Table 1—Principles of Good Sleep Hygiene

Sleep schedule
Bedtime and wake-up time should be about the same time everyday. There should not be more than an hour difference in bedtime and wake-up
time between school nights and nonschool nights. Sleeping in on weekends to “catch-up” on sleep should be avoided.
Bedtime routine
Establish a consistent 20- to 30-minute bedtime routine. The routine should include calm activities, such as reading a book or talking about the
day, with the last part occurring in the bedroom.
Bedroom
The bedroom should be comfortable, quiet, and dark, except for a dim nightlight. Room temperature should be cool (less than 75 degrees). Using
the bed for activities (studying, talking on the phone) other than sleeping should be avoided.
Meals
Heavy meals within an hour or 2 of bedtime may interfere with sleep. However, a light snack (such as milk and cookies) before bed is acceptable
to avoid going to bed hungry.
Caffeine
Caffeine should be avoided for at least 3 to 4 hours before bed. Caffeine can be found in many types of soda, coffee, iced tea, and chocolate.
Alcohol
Alcohol may shorten sleep onset but disrupts sleep later in the night and, thus, should be avoided.
Smoking
Nicotine is a stimulant and may disturb sleep.
Evening activities
The hour before bed should be a quiet and calm time. High-energy activities and heavy exercise and stimulating activities, such as playing com-
puter games, should be avoided during that time.
Electronic media
Television sets, computers, etc. should be kept out of the bedroom to avoid establishing television viewing and playing video or computer games
as a learned sleep-onset association. These activities are also often highly stimulating.
Naps
In young children, naps should be geared to the child’s age and developmental needs. In older children and adolescents, naps should generally be
avoided, as prolonged daytime sleep can contribute to difficulty initiating and maintaining nocturnal sleep.
Exercise
Time should be spent outside every day, with a period of daily exercise.
Sunlight
Spending time outside every day, especially in the morning, and exposure to sunlight helps maintain normal sleep-wake circadian rhythms.

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Pharmacotherapy For Pediatric Insomnia

sitating a different treatment approach.
• Sleep problems in infants and very young children are almost
always related to “developmental asynchrony” between the
child’s sleep development and parental expectations (eg, devel-
opment of nocturnal-diurnal sleep-wake rhythms, “sleeping
through the night”). Therefore, medication is rarely, if ever, indi-
cated in this age group.
• In almost all cases, medication is not the first treatment
choice nor the sole treatment strategy. Medication use, except for
very self-limited circumstances such as travel, should be viewed
only within the context of a more comprehensive treatment plan.
• Medication should always be used in combination with non-
pharmacologic strategies (behavioral interventions, parent educa-
tion, etc). This is analogous to a number of other conditions in
children, such as attention-deficit/hyperactivity disorder, in
which a combination of pharmacologic and behavioral strategies
are often superior to drug treatment alone.
• Prior to consideration of pharmacologic treatment, sleep
hygiene should be always be optimized. All sleep disorders in
children may be exacerbated by poor sleep habits, such as exces-
sive caffeine use and irregular sleep-wake schedules, which must
be addressed before medication is recommended.
• Treatment goals should be realistic, clearly defined, and dis-
cussed and agreed upon with the family before treatment is initi-
ated. In addition, there must be clear plan for follow-up and
reassessment of therapeutic goals. In particular, the parental
expectations regarding the degree of amelioration of the sleep
problem by medication and the anticipated duration of drug treat-
ment should be clearly established.
• Medication use should be short term; no prescription refills
should be given without reassessment of the target symptoms and
assessment of patient compliance with both pharmacologic and
behavioral management.
• Adolescents should be screened for alcohol and drug use and
pregnancy prior to initiation of therapy. Many recreational sub-
stances may have synergistic clinical effects when combined with
sedatives/hypnotics. In addition, hypnotics with high toxicity lev-
els in overdose should be used with extreme caution in situations
in which there is any risk of nonaccidental overdose.
• Patients should also be screened for concurrent use of self-
initiated nonprescription sleep medications (Excedrin PM, mela-
tonin, herbal remedies). Some of these medications have similar
ingredients (eg, diphenhydramine is the soporific ingredient in
both Benadryl and Tylenol PM); while generally viewed by par-
ents as “safe,” the potential drug-drug interactions between most
herbal preparations and sedative/hypnotics are largely unknown.
• Medication selection, particularly in terms of duration of
action, should be appropriate for the presenting complaint—ie,
for problems with sleep onset, a shorter-acting medication is gen-
erally desirable. For problems with sleep maintenance, longer-
acting medications may be considered but are more likely to
result in “hang-over” effects the following morning.
• All medications should be used with caution and monitored
closely for efficacy and side effects. Since there are so few data
on safety and efficacy of these medications in children, a conser-
vative approach, similar to that which should be exercised with
any pediatric off-label drug use, is warranted.

Table 2—Summary of Empirically Based Nonpharmacologic Treatments for Pediatric Insomnia

Intervention Target problems Description Selected references

Extinction Bedtime disturbances/ Putting the child in bed and systematically Rickert VI31
night wakings ignoring inappropriate child behaviors Seymour FW32
(eg, crying) until morning.

Graduated extinction Bedtime disturbances/ Combining extinction with scheduled Reid MJ33
night wakings parental checks Hiscock H34

Early intervention/ Bedtime disturbances/ Education of parents in the establishment of Wolfson A35
parent education night wakings appropriate sleep habits (eg, sleep routines, Adair R36
put to bed awake) to prevent the development Kerr SM37
of sleep problems.

Scheduled awakenings Bedtime disturbances/ Parent awakening child 15-30 minutes before Rickert VI38
night wakings/parasomnias usual spontaneous awakening or parasomnia. Durand VM39
Frank NC40

Extinction with Bedtime disturbances/ Parent feigns sleep while staying in Sadeh A41
parental presence night wakings child’s room and ignoring inappropriate
child behaviors (extinction).

Positive bedtime routines Bedtime disturbances Parent developing a set bedtime routine that the Adams LA42
child enjoys and associating these routines with
positive behaviors (eg, falling asleep quickly).

Phase advance or Delayed sleep phase Systematically advancing or delaying child’s Okawa M43
delay chronotherapy syndrome sleep phase to desired sleep-wake schedule.

For an extended review see Mindell JA44 and Kuhn BR.45

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JA Owens, D Babcock, J Blumer et al

Table 3—Pharmacology of Selected Medications Used for Pediatric Insomnia47

Drug Half-life Onset of Class Mechanism Metabolism Drug-Drug Effects on

(T½) action/peak of Action Interactions Sleep
level, min Architecture

Rapid Benzodiazepine
absorption; (BZD)48 Bind to central Hepatic ETOH/ Suppresses SWS;
slowed by GABA receptors barbiturates reduces frequency
food increase CNS of nocturnal
Clonazepam 19-60 h 20-60 depression arousals
(Klonopin)
Flurazepam 48-120 h 20-45
(Dalmane)
Quazepam 48-120 h 20-45
(Doral)
Temazepam 3-25 h 45-60
(Restoril)
Estazolam 8-24 h 15-30
(ProSom)
Triazolam 8-24 h 15-30
(Halcion)
Chloral 10 h; 30 Unknown Nonspecific CNS Hepatic/renal Increases CNS Decreases SOL
hydrate decreases depression; & respiratory
(Noctec) with ?interaction with depressant effects;
increasing GABA receptors may alter effects
age in of anticoagulants
children;
T½ infants
3-4 x >
adults
Clonidine 6-24 h Rapid Alpha-receptor α-adrenergic receptor 50%-80% of Reports of serious Decreases SOL
(Catapres) absorption; agonists agonists; (guanfacine dose excreted CVS effects with
Guanfacine 17 h bioavailability more selective) unchanged in co-administration
(Tenex) 100%; onset decrease NE release urine with
action within 1 hr; psychostimulants49
peak effects 2-4 h
Zolpidem 2-4 h 30-60 Pyrimidine BZD-like Hepatic; no ETOH, CNS Decrease SOL,
(Ambien) derivatives active depressants may little effects
Zaleplon 2-4 h 30-60 metabolites potentiate effects sleep architecture
(Sonata)
Trazadone Biphasic; first 30-120 Atypical 5-HT, serotonin Hepatic Potentiates Decreases SOL
(Desyrel) T ½ 3-6 hours; antidepressant agonist effects of ETOH, improves sleep
second T½, CNS depressants, continuity
5-9 h, 10-36 h digoxin, phenytoin, decreases REM,
after ingestion and antihypertensives increases SWS
Melatonin50 30-50 min; 30-60 Hormone Main effect Hepatic Largely unknown; Decreases SOL;
returns to (sustained analogue circadian; NSAID, ETOH, main effect on
baseline levels released weak hypnotic caffeine, BZD may circadian rhythms
in 4-8 h; peak level, interfere with normal
biphasic 4 h) melatonin production
elimination;
3 min and
45 min; 90%
excreted in
4h
Diphen- 4-6, h Rapid absorption Antihistamines H1 subtype receptor Hepatic ETOH/CNS Decreases SOL;
hydramine and onset of agonists; first- depressants may impair
(Benadryl) action; peak levels generation drugs cross (barbiturates, opiates) sleep quality
Brompheni- 4-6, h 2-4 h blood-brain barrier
ramine
Chlorpheni- 4-6, h
ramine
Hydroxyzine 6-24, h
(Atarax)

SWS refers to slow-wave sleep (stage 3-4); SOL, sleep-onset latency; BZD, benzodiazepine; GABA, gamma-aminobutyric acid; CNS, central nervous system;
NSAID, nonsteroidal anti-inflammatory drug; NE, norepinephrine; ETOH, alcohol; REM, rapid eye movement sleep .

Journal of Clinical Sleep Medicine, Vol. 1, No. 1, 2005 54

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Pharmacotherapy For Pediatric Insomnia

Potential Indications for Hypnotic Use in Otherwise Normal
Children (Generally Short-Term Use)
• The safety or welfare of the child is threatened—eg, parent is
overwhelmed or unable to implement nonpharmacologic inter-
ventions. Because of their rapid onset of action, in this situation,
medications may assist in “breaking the cycle” and allow for the
implementation of effective behavioral strategies.
• There is a failure of or inability to comply with an adequate
Table 4—Clinical Properties of Selected Medications Used for Pediatric Insomnia46
trial of accepted nonpharmacologic/behavioral treatment, eg, the
older child or adolescent with psychophysiologic insomnia who
fails to respond to standard behavioral management such as stim-
ulus control and sleep restriction.
• Medication is used as an adjunct to sleep hygiene/chronother-
apy in circadian rhythm disturbances; eg, in an otherwise normal
adolescent with delayed sleep phase syndrome.
• The insomnia occurs in the setting of medical illness with

Drug Adult dosing Formulation Side effects Development Safety Comments

range (mg/d) tolerance/ profile/
withdrawal (overdose)
effects

Clonazepam 0.5-2.0 Tablets Residual daytime Yes, especially with Marked abuse Also used to control
Flurazepam 15-30 sedation, rebound shorter acting BZD; potential partial arousal
Quazepam 7.5-30 insomnia on withdrawal effects parasomnias
discontinuation, include seizures (night terrors, sleep
Temazepam 15-30 psychomotor/ walking); use short
cognitive impairment, half-life BZD
anterograde amnesia for sleep onset;
(dose dependent); longer half-life
Estazolam 1-2 impairment respiratory for sleep maintenance
Triazolam 0.125-0.25 function
Chloral hydrate 50-75 mg/kg; Capsules, syrup, Respiratory depression Yes, withdrawal after Poor tolerability Reports of possible
max 1-2 g/dose rectal suppository gastrointestinal (nausea, prolonged use may safety profile; liver toxicity; respiratory
vomiting, especially if taken cause delirium, overdose: CNS depression limits use
without food), drowsiness/ seizures depression, cardiac
dizziness arrhythmia,
hypothermia,
hypotension
Clonidine 0.025-0.3 Tablet, Dry mouth, Narrow therapeutic Also used in
(up to 0.8); transdermal patch bradycardia, index; daytime treatment
increase by hypotension, Overdose: of ADHD
0.05 increments rebound hypertension bradycardia,
Guanfacine 0.5-2 on discontinuation decreased
consciousness
hypotension
Zolpidem 5-10 Headache, May develop tolerance/ Well-tolerated in adults; Little clinical
retrograde amnesia; adaptation with overdose: CNS experience in
few residual extended use; may depression; children
Zaleplon 5-10 next-day effects develop rebound hypotension
insomnia on
discontinuation
Trazadone 20-50 Tablets Dizziness, CNS Overdose: May be used with
overstimulation, cardiac hypotension, comorbid depression
arrhythmias, hypotension, cardiac effects
priapism
Melatonin 2.5-5 (0.3-25) Tablet; Largely unknown; reported Unknown Used in children with
various strengths hypotension, bradycardia, developmental
nausea, headache Possible disabilities,
exacerbation of co-morbid mental retardation,
autoimmune diseases autism, pervasive
development disorders,
neurologic impairment,
blindness, jet lag
Diphenhydramine 25-50 (should Tablet, capsule, Daytime drowsiness, Overdose: Weak soporifics; high
not exceed daily syrup, injectable gastrointestinal hallucinations, level of parental/
dose 300mg) (appetite loss, nausea/ seizures, practitioner acceptance
Brompheniramine 4 vomiting, constipation, excessive
Chlorpheniramine 4 dry mouth), stimulation
paradoxical excitation
Hydroxyzine 25-100;
0.6mg/kg
(children)

BZD refers to benzodiazepine; CNS, central nervous system; ADHD, attention-deficit/hyperactivity disorder.

Journal of Clinical Sleep Medicine, Vol. 1, No. 1, 2005 55

review articles owens.qxp 1/4/2005 2:20 PM Page 56
JA Owens, D Babcock, J Blumer et al
associated issues, including pain control, concomitant medica-
tions, hospitalization, eg, the child on steroids for chronic asthma.
• The insomnia occurs in the context of an acute stressor, eg, a
death in the family.
• The insomnia occurs or is anticipated in the context of travel,
eg, a prolonged plane ride with accompanying time change.
Contraindications to Hypnotic Use in Otherwise Normal Children
• The insomnia occurs in the presence of untreated sleep-disor-
dered breathing, eg, obstructive sleep apnea. Not only is hypnot-
ic medication often inappropriate for treating the underlying con-
dition, but sedatives with respiratory-depressant properties (eg,
chloral hydrate) may be dangerous in the situation of a comorbid
sleep-related breathing disorder.
• The insomnia is due to a developmentally based normal sleep
behavior; for example, there are inappropriate expectations regard-
ing the child’s sleep behaviors from the parent or practitioners.
• The insomnia is due to a self-limited condition that tem-
porarily results in night wakings, eg, teething.
• There are potential drug interactions with concurrent medica-
tions (eg, opiates) or unrecognized substance abuse or alcohol use.
• There is limited ability to follow up with and monitor the
patient, eg, parent frequently misses scheduled appointments.
Pharmacologic Treatment of Pediatric Insomnia in Children
with Special Needs
Sleep disturbances are a prominent part of the morbidity of
neurobehavioral, psychiatric, and chronic medical conditions.55,56
Whether as a primary condition or secondary to the chronic con-
dition, pediatric insomnia may contribute to exacerbation of these
conditions and have an adverse impact on the quality of life for
the child and family. Children with chronic medical and develop-
ment conditions are particularly prone to insomnia because of
unique combinations of family stresses, caregiver interactions,
social (peer) relationships, medical needs, sedating or activating
medications, physical challenges, or psychiatric co-morbidity.
For example, factors common to many medical conditions that
can also create or exacerbate insomnia include pain, pruritus,
Table 5—Pharmacology and Clinical Properties of Selected Herbal Preparations Used for Pediatric Insomnia54
Common Name Scientific Name Mechanism
of Action
Valerian Valeriana officinalis Binds BZD receptors
German chamomile Matricaria recutita Binds BZD receptors
Kava Piper methysticum CNS depressant
Lavender Lavandula angustifolia CNS depressant
SWS refers to slow-wave sleep (stage 3-4); SOL, sleep-onset latency; BZD, benzodiazepine; CNS, central nervous system
Journal of Clinical Sleep Medicine, Vol. 1, No. 1, 2005
cough, abnormal movements, and other disturbances.57 The
physician must consider each of these potential factors, realizing
that several may coexist and frustrate therapeutic interventions.
Because the neural and cognitive requisites to develop and
express most sleep symptoms are basic, children with chronic
medical and developmental conditions are susceptible to the same
emotional, behavioral, medical, and circadian sleep disorders as
normal children. Therefore, these common causes of insomnia
should be considered first in children with chronic health condi-
tions and developmental disabilities and treated appropriately.58
As is the case with normal children, it is preferable to identify and
control the underlying process that creates a sleep disturbance
instead of simply prescribing symptomatic therapy for insomnia.
However, sleeplessness may overshadow other indicators of pri-
mary medical and psychiatric disorders and, thus, appear to arise
de novo in an otherwise healthy child. For example, insomnia
often is a presenting symptom of many psychiatric disorders such
as depression, posttraumatic stress disorder, and generalized anx-
iety disorder. If not carefully sought, other symptoms of psychi-
atric and medical conditions may be missed, and an opportunity to
eliminate the basis of the insomnia would be lost.
Children with neurologic injury and specific genetic, psychi-
atric and behavioral syndromes and conditions are particularly
susceptible to specific types of insomnia. Examples include
autism and pervasive developmental disorder, blindness (circadi-
an rhythm disorders), Smith-Magenis syndrome (severe insom-
nia), Williams syndrome (periodic limb movement disorder),
Rett syndrome (prolonged sleep-onset latency, sleep fragmenta-
tion), and Tourette syndrome (increased nocturnal movements
and awakenings).56,59 Children with attention-deficit/hyperactivi-
ty disorder are often reported by parents to have sleep-onset dif-
ficulties and restless sleep and present one of the more common
chronic conditions for which sedatives are recommended by
pediatric practitioners.60-62 Children with asthma and atopy, renal
failure, and epilepsy are also highly prone to sleep disruption
related to the underlying chronic condition, medication, or both.
Thus, the physician may be guided by literature relevant to the
specific diagnosis.63-66
The approach to insomnia in children with underlying medical
Sleep Architecture Usual Dose Comments
Effects
Decreases SOL, 2-3 g in tea every day Reported toxicity rare; effects
improves sleep to t.i.d: extract may take several weeks
continuity; ?increases equivalent to 2-3 g
SWS
?Decreases SOL 1-3 gm in tea t.i.d Weak hypertensive effect; may
cause contact allergies
Improves sleep quality 60-120 mg every day May have anxiolytic effects;
does not appear to potentiate
alcohol, BZD effects
Improves sleep quality, Essential oil; May potentiate effects alcohol
decreases restless sleep inhalation
56
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or developmental conditions must take into account expected
efficacy in light of a patient’s behavioral strengths and chal-
lenges, capabilities and needs of families and caregivers, health-
care priorities or urgencies that may temporarily supersede long-
term interests, and impact of insomnia therapy on underlying
medical conditions and concurrent medications. For example, a
teenager with mild mental retardation might not be able to take a
hypnotic in a reliable manner, a family in crisis may need the
rapid effect of a hypnotic until behavioral interventions take
effect, and melatonin has the potential to lower the seizure
threshold in a child with an underlying seizure disorder. In addi-
tion, because of frequent concurrent use of other medications and
the idiosyncratic response that these children may have to seda-
tive/hypnotics, extreme caution should be exercised in regard to
medication choice and monitoring of side effects.
The task force therefore recommends that specific history
about quality of sleep be an integral part of the evaluation and
maintenance care of children with chronic medical and mental
health conditions. Pharmacologic therapy should be considered
for sleep problems as part of the overall management strategy, in
conjunction with behavioral therapy and sleep hygiene. Sleep
problems in these children should be managed aggressively to
avoid exacerbation of the underlying condition and improve
overall quality of life; longer duration of drug therapy is often
necessary in these children. Consultation with a pediatric neurol-
ogist, developmental behavioral pediatrician, or sleep specialist
is often warranted.
RESEARCH NEEDS
The lack of well-designed controlled studies concerning the
efficacy, tolerability, dosing, and safety profile of soporific drugs
in children impedes the rational clinical management of child-
hood insomnia. The recommendations that are presented here are
of necessity based on clinical experience and at this time cannot
be evidence based. Further research based on well-designed con-
trolled studies is necessary to develop standards of practice for
this important pediatric problem. Concerning pediatric insomnia,
health professionals responsible for the care of children should
set as goals the comprehensive understanding of this problem;
the establishment of an evidence-based understanding of appro-
priate treatment choices for this problem, especially pharmaco-
logic treatment for childhood sleep problems; and the education
of themselves and society in general. The task force recommends
that research studies be designed to address the following specif-
ic questions.
What is the Spectrum of Childhood Insomnia?
Development of a consistent nosology takes into consideration
the possibility of different patterns of insomnia, as these may
vary depending on developmental status and age of the child.
Other factors may influence the character of these patterns and
warrant investigation. These include parental expectations con-
cerning childhood sleep, as well as the impact of cultural back-
ground, socioeconomic status, and environment on insomnia.
This knowledge will be important to identify at-risk children. Of
particular interest are studies of special needs groups, including
children with chronic pain syndromes, attention-deficit/hyperac-
tivity disorder, psychiatric problems such as depression or anxi-
Journal of Clinical Sleep Medicine, Vol. 1, No. 1, 2005
Pharmacotherapy For Pediatric Insomnia
ety, bipolar disorder, and pervasive developmental-autism spec-
trum disorders. These children appear to be at high risk for devel-
oping or having sleep problems and may benefit from the use of
medications in addition to traditional behavioral approaches.
How Do We Assess Pediatric Insomnia?
The diagnosis of childhood insomnia is a clinical diagnosis.
Overnight sleep studies are useful to rule out other causes of
nighttime sleep problems such as sleep apnea but not for the diag-
nosis of insomnia. Questionnaires and tools such as sleep diaries
play an important role in this diagnosis. Instruments specifically
addressing childhood insomnia are lacking. Validated instru-
ments should be developed that can screen large populations of
children of all ages and developmental status, reliably identify at-
risk children, and assess severity. These instruments should
include those with sufficient rigor for the researcher, as well as
those that can be reasonably used to screen children seen by pedi-
atricians and family practice physicians. There is a need to devel-
op outcome measures specific to childhood insomnia. These will
depend on a clear understanding of the natural history and long-
term outcome of this problem, as well as the impact on the day-
time cognitive and behavioral function of the child and on the
quality of life of the child and of the family.
What Drugs Are Efficacious and Safe to Treat Childhood
Insomnia?
The current use of pharmacologic agents to treat children with
sleep problems lacks a sound basis to guide the rational choice of
a specific medication, dose of that medication, or duration of
therapy. To address these concerns, research efforts should be
directed to evaluate currently used medications. These include
prescription medications such as clonidine, trazodone, and chlo-
ral hydrate; nonprescription medications such as diphenhy-
dramine, melatonin, and valerian; and medications with current-
ly established indications in adults such as zolpidem and zale-
plon. Clinical trials of these drugs should establish the effective
dose, address safety issues, and determine efficacy for inducing
sleep. Additionally, withdrawal and discontinuation effects need
to be examined. Outcome measures should also include the
impact of the specific drug on daytime cognitive and behavioral
functioning. The development of new drugs that meet the “ideal”
hypnotic profile should be supported. There is a need to evaluate
the impact on sleep and sleep-related outcome measures of non-
hypnotic drugs, such as stimulants and antidepressants.
What Education Programs Need to Be Developed and Who
Will Benefit from These Programs?
A simple answer is any health professional involved in the care
of children. Our current knowledge base suggests that pediatric
insomnia is a common and pervasive problem among children of
all ages and significantly impacts on the child’s sleep and day-
time cognitive and behavioral functioning, and the quality of life
of the child and the family. The impact of the knowledge gained
from the suggested research will be only as good as our ability to
disseminate that information to health professionals. Currently,
for those involved in the day-to-day care of children, few hours
are spent in training programs and during continuing medical
57
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JA Owens, D Babcock, J Blumer et al
education efforts concerning childhood sleep problems in gener-
al and pediatric insomnia in specific. The significance of this
problem merits the development of education programs address-
ing pediatric sleep issues for health professionals in training as
well as primary care practitioners.
SUMMARY
The use of pharmacotherapy in the treatment of pediatric sleep
disorders presents both opportunities and challenges for the prac-
ticing community-based physician, for sleep specialists, for
providers of special needs populations, and for the pharmacolog-
ic research community. These task force recommendations are
the first steps in an ongoing effort to maximize care for children
with serious sleep complaints and their families. This effort will
necessarily include generating the data needed to produce evi-
dence-based guidelines and developing the methodology to mea-
sure appropriate outcomes in clinical practice. It is our hope that
by highlighting the clinical needs, summarizing the current
research and clinical “state of the art,” and providing a template
for future research, these task force recommendations will move
the field closer to achieving these goals.
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