Transcript owensNESS2011 - North East Sleep Society

The Elephant in the Nursery;
Different Perspectives on Insomnia in Children
Judith A. Owens MD MPH
Children’s National Medical Center
Washington DC
Northeastern Sleep Society Annual Meeting
April 2011
Disclosures
• In the past 12 months, I have had the following
financial relationship with the manufacturers of
commercial products:
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Eli Lilly (Speakers Bureau)
Shire (Speakers Bureau, Research grant)
Rhodes Pharmaceuticals (Consultant)
Takeda (Consultant)
Shionogi Pharma (Consultant)
Cephalon (Consultant)
Neuropro (Consultant)
Transcept (Consultant)
Isis Biopolymer (Advisory Board)
Off-label drugs will be discussed
Objectives
• Review controversial issues regarding
insomnia in children:
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Definitions
Cultural considerations
Behavioral interventions
Pharmacologic treatment
What is “Pediatric Insomnia”?
• Descriptive, not diagnostic term
• Dependent on parental recognition/definition
• Multiple possible medical/behavioral etiologies for
same constellation of symptoms
• Occurs in evolving developmental context
• Treatment should be diagnostically-driven
• Evaluation is key
Consensus Definition
• Repeated difficulty with sleep initiation, duration,
consolidation, or quality
– Viewed as problem by the child and/or caregiver
– Occurs despite age-appropriate time/opportunity for sleep
– Results in daytime functional impairment for the child
and/or family
• Significance of the sleep problem determined by:
– Severity, chronicity, and frequency of behavior
– Child and parent variables
– Cultural considerations
Clinical Definition
• Bedtime refusal or resistance
• Delayed sleep onset
• Prolonged night wakings
– Or some combination
• Requires parental
intervention
Pediatric Insomnia: Diagnostic
Classification
• DSM-IVR
• ICSD II
– Primary Insomnia
– Insomnia related to
another mental
disorder
– Associated with
general medical
condition or
substance abuse
– Behavioral Insomnia of
Childhood
• Sleep onset association
• Limit setting
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Psychophysiologic
Adjustment
Idiopathic
Associated with mental
disorders, medical
conditions or medications
Proposed DSM V Insomnia Disorder
A. The predominant complaint is dissatisfaction with sleep quantity or
quality made by the patient (or by a caregiver or family in the case of
children or elderly).
B. Report of one or more of the following symptoms:
-Difficulty initiating sleep; in children this may be manifested as
difficulty initiating sleep without caregiver intervention
-Difficulty maintaining sleep characterized by frequent awakenings
or problems returning to sleep after awakenings (in children this
may be manifested as difficulty returning to sleep without caregiver
intervention)
-Early morning awakening with inability to return to sleep
-Non restorative sleep
-Prolonged resistance to going to bed and/or bedtime struggles
(children)
Proposed DSM V Insomnia Disorder
C. The sleep complaint is accompanied by significant distress or
impairment in daytime functioning as indicated by the report of at
least one of the following:
-Fatigue or low energy
-Daytime sleepiness
-Cognitive impairments (e.g., attention, concentration, memory)
-Mood disturbance (e.g., irritability, dysphoria)
-Behavioral problems (e.g., hyperactivity, impulsivity, aggression)
-Impaired occupational or academic function
-Impaired interpersonal/social function
-Negative impact on caregiver or family functioning (e.g., fatigue,
sleepiness
Proposed DSM V Insomnia Disorder
D. The sleep difficulty occurs at least three nights per week.
E. The sleep difficulty is present for at least three months.
F. The sleep difficulty occurs despite adequate age-appropriate
circumstances and opportunity for sleep.
Duration:
1. Acute insomnia (<1 month)
2. Sub acute insomnia (1-3 months)
3. Persistent insomnia (> 3 months)
Clinically Comorbid Conditions:
-Psychiatric disorder (specify)
-Medical disorder (specify)
-Another disorder (specify)
Behavioral Insomnia of Childhood:
ICSD-II Definition
• Sleep Onset Association subtype
– Falling asleep is an extended process that
requires special conditions
– Sleep-onset associations are highly
problematic or demanding
– In the absence of the associated conditions,
sleep onset is significantly delayed or sleep is
otherwise disrupted
– Nighttime awakenings require caregiver
intervention for the child to return to sleep
Behavioral Insomnia of
Childhood: ICSD-II Definition
 Limit Setting subtype
– The child has difficulty initiating or maintaining
sleep
– The child stalls or refuses to go to bed at an
appropriate time or refuses to return to bed
following a nighttime awakening
– The caregiver demonstrates insufficient or
inappropriate limit setting to establish
appropriate sleeping behavior in the child
Pros and Cons
• Sleep issues are defined
as “problems” in young
children because they
disturb parental sleep
• Disrupted sleep is
problematic due to direct
negative consequences
on child mental and
physical health
• Caregiver sleep
disruption increases
family stress and
compromises parenting
• Clinicians “pathologize”
night wakings
• Clinicians respond to
legitimate parental
concerns
Sleep and Culture:
Differences and Similarities
• Sleeping environment
• Infant sleep practices
(bed-sharing/cosleeping,
sleeping position)
• Napping patterns
• Bedtime rituals,
transitional objects
What is Cosleeping?
• The practice of having an infant or young child
share a sleeping space with mother and/or
father (caretaker)
• Types:
– Isolated (extraordinary circumstances)
– Occasional >1x/mo, <3x/wk vs frequent or habitual
>=3x/wk
– All night/ part-night
– Room-sharing, proximate, bed-sharing
– ”Reactive” vs “lifestyle” cosleeping distinction
Why Look at Culture?
• Eastern vs Western beliefs in bed-sharing
– Very high acceptance and rates of cosleeping in Asian societies
– Relatively less value placed on development
of independence in young children
– Family interdependence vs individual
autonomy
Pros and Cons
• Infant sleep problems result
from “Westernization” of
traditional sleeping practices
• The transition to “solitary sleep”
is a natural reflection of societal
changes
• Solitary sleep is at best
impractical and at worst
psychologically harmful to the
child
• Cosleeping may be associated
with more fragmented and less
deep sleep, increased stress
response and more sleep
problems
• Cosleeping is the optimal
sleeping arrangement
• Cosleeping is a lifestyle choice
Behavioral Interventions for
Insomnia: Definitions
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Extinction
Bedtime fading
Positive routines
Scheduled awakenings
Positive reinforcement
Parental education
Extinction
• Elimination of parental attention as a reinforcer for
undesired behaviors (e.g., crying)
• Unmodified extinction (“cry it out” or “cold turkey”
approach): parents put the child to bed at a
designated bedtime, and then ignore protest
behaviors such as tantrums until a preset time the
next morning
– Effective but poorly tolerated by many parents
– Variations include parent sleeping in child's room, in
separate bed, while carrying out systematic ignoring
Extinction
• Graduated extinction (“sleep training,
checking, controlled crying, Ferber
method”): variety of techniques in which
parents are typically instructed to ignore
bedtime crying and tantrums for
specified periods of time
• Involve gradual shaping of appropriate
behaviors and fading of interventions
Treatment Issues
– Common for crying/protest to briefly intensify 2nd or
3rd night (“extinction burst”) - vomiting
– Avoid intermittent reinforcement (the “lottery theory”)
– Avoid increasing reinforcement during checks
– Do not allow child to extend day sleep
– Improvement in one week if parents consistent
– Easier to accomplish before child developmentally
able to climb out of crib or has been transitioned to a
bed
Variations on Graduated
Extinction
• Parent stays with child at sleep onset, gradually
fades attention, assistance, and presence
• Parent sits in chair at sleep onset, gradually
moves chair out of room
• Parent sleeps beside child’s bed, gradually
moves bed out of room
• Child allowed to sleep on separate bed in
parent’s room during night wakings
• Bedtime pass
Behavioral Treatment of Bedtime Problems and
Night Wakings in Infants and Young Children *
• Review of 52 studies
– Behavioral treatment produces clinically significant,
reliable, and durable changes (80% of children
improve)
– Positive effects on secondary outcome variables
• Child-related, such as daytime behavior
• Caregiver-related, such as parental well-being
– 94% of studies report intervention was efficacious
– Adverse secondary effects not identified in any studies
* AASM Standards of Practice Committee Review
Mindell et al., Sleep, Oct 2006
AASM Practice Parameters*
• Standards
– Unmodified extinction
– Extinction with parental presence
– Parental education
• Guidelines
– Graduated extinction
– Bedtime fading/positive routines
– Scheduled awakenings
*Morgenthaler et al, Sleep, Oct. 2006
Pros and Cons
• Behavioral interventions
“teach” parents to ignore their
crying/distressed child
• Behavioral interventions may
be viewed as “neglect”
• Treatment may compromise
infant-parent attachment
security
• Behavioral interventions
regulate how quickly and
appropriately parents respond
to crying
• Successful treatment improves
infant and caregiver sleep and
well-being
• Beyond short-term distress,
negative consequences have
not been identified
• Self-soothing is the first step in
the development of selfregulation
Medications for Insomnia
• 25% of first-born infants had been given
“sedatives” by 18 months (Ounstead, 1977)
• 35% of prescriptions in < 1yr olds for sleep
disturbances; 23% 2-5 yr olds; most common
type drug therapy;chlorpromazine most
frequent (Trott, 1995)
• 49% of pediatricians reported recommending
OTC antihistamines, 15% prescription
antihistamines for sleep in 0-2 yo (Owens,
Pediatric Survey: Prescription
Medications for Insomnia
Percent of respondents prescribing
Child Psychiatry Survey: Prescription
Medications for Insomnia*
*In a “typical” month
Owens et al 2010
Medication Use:
General Principles
• Medication rarely first choice or sole treatment strategy
• Optimize sleep hygiene
• Combine with behavioral therapy: increased long-term
efficacy and decreased side effects
• Treatment selection based on clinical assessment of
best possible match between clinical situation and drug
properties
• Treatment goals:
o
o
o
realistic, clearly defined, measurable
agreed upon by caregivers
have plan for follow-up
• Initiate lowest dose; titrate as needed
• Shortest possible duration of therapy
Medication Use: General
Principles
• Selection of appropriate meds
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short-acting meds for sleep onset
longer-acting meds for sleep maintenance
minimize “am hangover”
• Timing of administration
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Hypnotic vs chronobiotic (melatonin)
“Forbidden zone” of circadian alertness
• Side effects reviewed with family
• Frequent monitoring efficacy, side effects
• Avoidance abrupt discontinuation (rebound)
Medication Use: Safety Issues
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Screen adolescents for alcohol/drug use, pregnancy
Screen for use OTC sleep meds
Assess possible drug-drug interactions (PK/PD)
“Paradoxical” effects
Exacerbation co-existing sleep disorders (ie,
SSRIs/RLS, risperidone/OSA)
• Contraindications:
• Insomnia occurs in presence of untreated primary sleep
disorder (SDB, RLS, DSPD)
• Insomnia due to developmentally-based normal sleep behavior
• Insomnia due to self-limited condition
• Potential drug interactions/substance use
• Limited ability to monitor meds
There are currently
no sleep medications
labeled for use in
children by the FDA
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Little empirical data: case reports/series
Few pediatric randomized controlled trials
Extrapolation adult data
Clinical experience guides usage
Diphenhydramine: Pediatric
Studies
• DB RCT 50 children 1mg/kg: subjective
improvement SOL, NW1
• “TIRED” study2
o Design: 44 6-15 month olds with night wakings
 1-week DB, PC RCT; f/up 2,4 wks
o Outcomes: parent-reported decrease night
wakings requiring assistance, improved sleep,
parental satisfaction sleep, SOL
o Results: 1/22 DPH vs 3/22 improvement
o Data safety monitoring board stopped trial due to
lack of efficacy
1Russo 1976 2Merenstein
2006
Melatonin: Pediatric Studies
• Increased duration and/or quality of
sleep in special needs (eg, blind,
MR, Rett syndrome, Angelman’s)
children with irregular sleep-wake
patterns and phase delay1:
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Effects variable across individuals
Generally well-tolerated
Some improvement daytime functioning
No long-term data efficacy, safety
1Malow
2008
Melatonin: Pediatric Studies (ADHD)
• Premise: Children with ADHD have a delayed
endogenous circadian clock
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ADHD patients with sleep onset insomnia vs
normal controls have significantly later sleep
onset, morning wake time, melatonin onset
• Several studies suggest 5 mg bedtime
melatonin significantly shortens SOL in children
with ADHD1-4
1-2Smits et al 2001, 2003; 3-4Van der Heijden et al 2005,
2007
Melatonin: Pediatric Studies (ADHD)
• 27 ADHD patients treated sequentially with
“sleep hygiene” (consistent bed/wake time,
avoidance of caffeine, naps) and melatonin 5
mg QHS or placebo1
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5 patients “sleep hygiene responders” (SOL
minutes)
60
 Sig reduction mean SOL 98 minutes to 73 minutes
 CGI sleep no change in 54%
o
Melatonin vs placebo (crossover design)
 Sig reduction mean SOL 16 minutes
 No difference in night-to-night variability, sleep duration,
CGI sleep, ADHD ratings
 90-day open-label trial with melatonin treatment responders
 Mean SOL 31 minutes
 Sleep duration increased 23 minutes
1Weiss 2006
NBzDRAs: Pediatric Studies
• Case study 7yo ASD: reduction SOL
• Zolpidem trial; DB/PC/parallel design1
N=201; ADHD –related insomnia
0.25mg/kg – max dose 10mg
No significant change mean change SOL week 4
drug vs placebo; improved CGI 12-17yo
o No residual sedation/rebound
o Side effects: dizziness, headache, hallucinations;
7% discontinuation due to AEs
o Children may require dose > adults
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1Blumer 2009
Clonidine: Pediatric Studies
• Retrospective chart review 62 pts1
o Improvement medication-induced/exacerbated,
baseline sleep disturbance
o AE’s in 31%; mild (am drowsiness)
• Description of clinical experience 100 pts2
o Rapid onset action; all-night duration (30 minutes)
o Parent-reported improvements sleep, ADHD
o No adverse events
• Adequate clinical response, low side effect profile3
• Caveats
o Reports sudden death in combination with
stimulants4
o Increase in ER reports clonidine toxicity5
1Prince 1994, 2Wilens et al 1995 3Ingrassia 2005 4Popper 1995
5Kappagoda 1998
Case 1: “She’s going to put me in
the hospital”
• Four year old girl difficulties maintaining sleep
• SH:38 yo single mother - 8th grade education, hx
of sexual/physical abuse, depression, PTSD,
previous psych hospitalizations
• FH:Mother, mat GM “insomnia”
• Med:Mother on methadone during pregnancy
• Dev: Child is “2 years behind in everything”
?ADHD, temper tantrums, aggressive
Case 1
• Bedtime 9p; actual sleep onset “10p-1a”; frequent “curtain
calls”; needs mother in room to fall asleep
• Night wakings frequent on sleep diary
– 11p: “wanted to eat ice cream”
– 1a, 3a: “put TV on”
– 5a: “had some milk”; fell asleep mother’s bed
• Previous treatment:
– Diphenhydramine qhs: “it stopped helping”
– Alpha agonist qhs discontinued due to side effects (increase
parasomnias): “the pills helped more than you know”
• Current status: “I can’t take this anymore; I’m afraid of
what will happen”
Differential Diagnosis of Bedtime
Resistance/Night Wakings in Young Children
• Behavioral Insomnia of Childhood:
– Sleep Onset Association subtype
– Limit Setting subtype
– Combined
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Sleep disorders related to medical conditions
Environmental factors
Inadequate sleep hygiene
Medications
Evaluation of Bedtime Resistance/Prolonged Sleep Onset
Assess for
Inadequate Sleep
Hygiene
Anxiety symptoms
Primarily bedtime-related
Sleep onset in relation to
bedtime
Daytime and bedtime
Generalized
Anxiety Disorder
Anxiety falling or Dream-related
staying asleep
anxiety
Primary insomnia Nightmares
Younger age
Developmentally
Inappropriate
bedtime
Developmentallyappropriate fears
Nighttime Fears
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Circadian
preference
Older age
Delayed Sleep
Phase
Syndrome
Falls asleep easily
at later bedtime
Chronic medical or
psychiatric conditions
Consistent prolonged
sleep onset
Leg sensations
relieved by
movement, +FH
Restless Leg
Syndrome
Parental presence
needed to sleep;
nightwakings
Sleep Onset
Association Disorder
Assess parentchild interactions,
child behavior
Bedtime refusal,
delaying tactics; no or
few nightwakings
Limit-Setting Sleep
Disorder
Case 1: Key Points
• Role of psychosocial factors and
neurodevelopmental issues in the decision
to use (or not use) a hypnotic
• Impact of previous drug therapy
• Role of behavioral management; how
likely is behavioral management alone to
be successful?
What would you do first?
• Institute sleep hygiene and behavioral
interventions (graduated extinction,
bedtime fading)
• Restart clonidine 0.05 mg qhs
• Defer treatment and refer to a child
psychiatrist for evaluation of ADHD
Case 2: A Child with Special Needs
• 8 year old boy with autism spectrum disorder and
the following sleep complaints:
– Delayed sleep onset with time to fall asleep > 90 min
– Active parental involvement at bedtime, rigid bedtime
routines
– Prolonged and disruptive nightwakings lasting on
average 40-90 minutes almost every night
– Early and irregular morning waketimes >2x/week
– Irregular sleep/wake schedule with prolonged daytime
naps during inappropriate time of day (late afternoon)
– Frequent co-sleeping
• Non-verbal, moderate MR, intermittently
aggressive, self-stimulatory behaviors
Differential Diagnosis of Sleep
Problems in ASD
• Chronobiological:
– Circadian rhythm abnormalities
• Disturbance in melatonin production in autism
• Less entrainment by social/environmental cues
– Primary arousal dysfunction; ?altered homeostasis
– Sensory issues
• Psychosocial
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Learned maladaptive sleep patterns
Anxiety-related; high levels autistic children
Inadequate parent limit-setting
Parents may be more aware of difficulties than parents of typically
developing children
– Parents may see sleep problems as “inevitable” and therefore untreatable
• Many patients have more than one etiology
• Some patients may have more than one sleep disorder
Case 2: Key Points to Consider
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Chronicity and severity of sleep disorder
Sleep onset and maintenance issues
Role of underlying CNS abnormalities
Impact on family
Impact of daytime functioning
Family’s goals
What would you do first?
• Initiate trial of melatonin 3 mg at bedtime
• Institute light box phototherapy in am
• Initiate trial of sedating atypical antipsychotic
(eg, risperidone) qhs
• Institute sleep hygiene and behavioral
interventions (graduated extinction, bedtime
fading)
• Initiate trial of controlled-release non-BZD
receptor agonist
Treatment Strategies
• Pharmacological
treatment
– Melatonin qhs
– Multiple medications used
clinically (eg, alpha
agonists, antidepressants,
atypical antipsychotics,
anticonvulsants)
• Circadian-based
interventions
– Chronotherapy
– AM bright light
• Sleep hygiene
• Behavioral management
– Bedtime routines
– Extinction procedures
– Bedtime fading
• Occupational therapy
– Brushing
– Weighted vests, blankets
• Sleep environment
– Safety issues
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Thank You!