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BMJ Clinical Evidence logoLink to BMJ Clinical Evidence
. 2007 Sep 1;2007:2304.

Sleep disorders in children

Paul Montgomery 1,#, Danielle Dunne 2,#
PMCID: PMC2943792  PMID: 19450298

Abstract

Introduction

Sleep disorders may affect 20-30% of young children, and include excessive daytime sleepiness, problems getting to sleep (dysomnias), or undesirable phenomena during sleep (parasomnias), such as sleep terrors, and sleepwalking. Children with physical or learning disabilities are at increased risk of sleep disorders.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for dysomnias in children? What are the effects of treatments for parasomnias in children? We searched: Medline, Embase, The Cochrane Library and other important databases up to September 2006 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 14 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: antihistamines, behavioural therapy plus benzodiazepines, or plus chloral and derivates, exercise, extinction and graduated extinction, light therapy, melatonin, safety/protective interventions for parasomnias, scheduled waking (for parasomnias), sleep hygiene, and sleep restriction.

Key Points

Sleep disorders may affect 20-30% of young children, and include excessive daytime sleepiness, problems getting to sleep (dysomnias), or undesirable phenomena during sleep (parasomnias), such as sleep terrors, and sleepwalking.

  • Children with physical or learning disabilities are at increased risk of sleep disorders. Other risk factors include the child being the first born, having a difficult temperament or having had colic, and increased maternal responsiveness.

There is a paucity of evidence about effective treatments for sleep disorders in children, especially parasomnias, but behavioural interventions may be the best first-line approach.

Extinction and graduated extinction interventions improve settling and reduce night wakes compared with placebo in healthy children, and in children with learning disabilities.

  • Graduated extinction may be less distressing for parents, and therefore may have better compliance.

  • Sleep hygiene interventions may reduce bedtime tantrums in healthy children compared with placebo, with similar effectiveness to graduated extinction.

  • Sleep hygiene plus graduated extinction may reduce bedtime tantrums in children with physical or learning disabilities.

  • We don't know whether combining behavioural therapy with benzodiazepines or with chloral improves sleep or parasomnias.

Melatonin may improve sleep onset and sleep time compared with placebo in healthy children, but we don't know if it is beneficial in children with disabilities, if it improves parasomnias, or what its long-term effects might be.

About this condition

Definition

The International Classification of Sleep Disorders-2 (ICSD-2) defines more than 80 sleep disorders, many of which apply to children — although often in different ways — as much as to adults. Sleep problems can be divided into two broad areas: too much sleep (dysomnias), or too little sleep (parasomnias). Dysomnias are disorders that produce either excessive daytime sleepiness, or difficulty initiating or maintaining sleep. They can be intrinsic, extrinsic, or circadian rhythm sleep disorders. Dysomnias include: primary insomnia, primary hypersomnia, narcolepsy, breathing-related sleep disorders, and circadian rhythm sleep disorder. Parasomnias are undesirable phenomena that occur predominantly during sleep. They are caused by inappropriately-timed activation of physiological systems. Parasomnias include: nightmare disorder, sleep terror disorder, and sleepwalking disorder. Children with physical or learning disabilities: Sleep problems tend to be greater in prevalence and severity in this population. For example, pain is related to sleep disturbance, and attention paid to helping the child sleep better is likely to improve recovery. Across a range of physical problems, there are reports in the literature of sleep disturbance associated with them. In most cases, research is limited and the mechanisms are unclear. Children with visual impairment are prone to circadian rhythm problems: their light perception is poor, and the primary cue for sleep onset is lost. Many medications are known to cause sleep problems — such as severe drowsiness with many antiepileptic drugs. Learning disabilities vary considerably in the range of conditions covered by this global term. However, some conditions such as Smith-Magenis, Prader-Willi, and Williams syndrome have sleep disturbance as cardinal features. Others, such as Down's syndrome and mucopolysaccharidoses, are associated with sleep-related breathing problems. Treatment for these groups of children needs to be tailored to their particular problems, and may be problematic for anatomical and neurological reasons. Nevertheless, in large part, these sleep problems should be regarded as treatable, and careful investigation of these problems is required.

Incidence/ Prevalence

Sleep problems, primarily settling problems and frequent night wakings, are experienced by about 20-30% of children aged 1-5 years, but cultural differences would seem to play at least some role. These sleep disturbances often persist in later childhood: 40-80% of children displaying sleep problems when aged 15-48 months were found to have persistent sleep disorders 2-3 years later. In toddlers, settling and night waking problems are dominant, with rates about 20-25%. A second peak in sleep problems occurs in adolescence, where sleep-timing problems including delayed sleep phase syndrome occur. Such children have difficulty getting off to sleep, and then problems getting up in the morning for school. Across the age range, sleep-related breathing problems occur at rates about 2%. Narcolepsy is thought to occur with a prevalence of 4-6/10,000 in the USA in adults, with the onset of symptoms tending to occur in the second decade. Children with physical or learning disabilities: Prevalence of sleep disorders tends to be even greater in children with physical or learning disabilities: about 86% of children aged up to 6 years, 81% of children aged 6-11 years, and 77% of children aged 12-16 years with physical or learning disabilities suffer from severe sleep problems. We found no separate data for dysomnias and parasomnias.

Aetiology/ Risk factors

Evidence of the aetiology of sleep disorders in children is generally limited; however, the proportion of rapid eye movement (REM — active sleep) is greater in infants than in adults. REM is frequently associated with awakenings, and infants with a sleep disorder often need assistance to resume sleep after such arousals. Factors related to sleep disorders are: having had colic, the child being the first born, and the child having a difficult temperament (e.g. low sensory threshold, negative mood, decreased adaptability). Other factors have been suggested, such as being born prematurely and low birth weight; however, evidence of such associations is contradictory. These factors may influence the onset of a sleep disorder, but the factors influencing the maintenance of a sleep problem are likely to be different. Increased maternal responsiveness is associated with the maintenance of sleep disorders in children.

Prognosis

Children with excessive daytime sleepiness or night waking are likely to suffer from impaired daytime functioning without treatment, and their parents are likely to have increased stress. In addition to these effects, children with parasomnias are at serious risk of accidental injuries. Between 40% to 80% of children aged 15-48 months displaying sleep problems had persistent sleep problems 2-3 years later. Children with physical or learning disabilities: Children with learning disabilities and sleep disorders are more likely to have greater challenging behaviour than those without sleep problems. This naturally affects the quality of life of the parents, frequently resulting in maternal stress, mothers displaying less affection for their children, and marital discord. For children with epilepsy, sleep disorders may exacerbate their condition: a persistent lack of sleep has been associated with an increased frequency of seizures.

Aims of intervention

To improve parental and child satisfaction with sleep; to prevent daytime sleepiness; and improve functional and cognitive ability during the daytime, with minimal adverse effects.

Outcomes

All sleep problems: Adverse effects of treatments; effects on parents (notably parental sleep); quality of life of child (including RAND-GHRI); quality of life of parent; Sleep Behavior Questionnaire. Insomnia: Sleep duration; night wakings (frequency and duration); sleep latency; bedtime tantrums (number and frequency); settling; Composite Sleep Disturbance Score; Compostive Sleep Index Score. Timing problems: Sleep onset time; sleep offset time; sleep duration.

Methods

BMJ Clinical Evidence search and appraisal September 2006. The following databases were used to identify studies for this review: Medline 1966 to September 2006, Embase 1980 to September 2006, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2006, Issue 3. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — for Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and National Institute for Health and Clinical Excellence (NICE). Abstracts of the studies retrieved were assessed independently by two information specialists using pre-determined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews and RCTs in any language, blinded for pharmaceutical interventions, and containing more than 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the review as required. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).

Table.

GRADE evaluation of interventions for sleep disorders in children

Important outcomes Sleep onset, duration and quality of sleep, bedtime tantrums, quality of life in both child and carer, adverse effects
Number of studies (participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of treatments for dysomnias in children?
2 (94) Sleep duration Extinction and graduated extinction v placebo (in otherwise healthy children) 4 –2 0 0 0 Low Quality points deducted for sparse data and poor follow-up
1 (45) Sleep duration Sleep programme v behavioural booklet advice (in otherwise healthy children) 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up
1 (36) Bedtime tantrums Graduated extinction v placebo (in otherwise healthy children) 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up
1 (36) Bedtime tantrums Sleep hygiene v graduated extinction (in otherwise healthy children) 4 –2 0 0 0 Low Quality point deducted for sparse data and incomplete reporting of results
1 (66) Sleep duration Graduated extinction plus sleep hygiene v placebo (in children with physical or learning disabilites) 4 –2 0 0 0 Low Quality points deducted for sparse data and poor follow-up
3 (90) Sleep duration Extinction and graduated extinction v placebo (in children with physical or learning disabilites) 4 –3 –1 –2 0 Very low Quality points deducted for sparse data, incomplete reporting, and poor follow-up. Consistency point deducted for conflicting results. Directness point deducted range of disabilities included
1 (36) Bedtime tantrums Sleep hygiene v placebo 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up
2 (102) Sleep duration Melatonin v placebo (in otherwise healthy children) 4 –3 –1 –2 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up. Consistency point deducted for conflicting results. Directness points deducted for uncertainty of measurement of outcome and population differences
2 (62) Sleep improvement Melatonin v placebo (in children with epilepsy) 4 –2 –1 –1 0 Very low Quality points deducted for sparse data and poor follow-up. Consistency point deducted for conflicting results. Directness point deducted for uncertainty about doses
1 (23) Sleep improvement Melatonin v placebo (in children with ADHD) 4 –3 0 0 0 Very low Quality points deducted for sparse data, poor follow-up, and uncertainty about methodology
What are the effects of treatments for parasomnias in children?
2 (62) Reduction of parasomnia Melatonin v placebo (in children with epilepsy) 4 –2 –1 –1 0 Very low Quality points deducted for sparse data and poor follow-up. Consistency point deducted for conflicting results. Directness point deducted for broad inclusion criteria

Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion. Consistency: similarity of results across studies. Directness: generalisability of population or outcomes. Effect size: based on relative risk or odds ratio.

Glossary

Actigraphy

An actigraph is a motion sensing device. It can be worn on the wrist overnight to provide data when a person falls asleep owing to change in the person's motion.

Circadian rhythm

The cycle of sleep and wake across the 24 hour day.

Dysomnias

are disorders that produce either excessive daytime sleepiness or difficulty initiating or maintaining sleep. They can be intrinsic, extrinsic, or circadian rhythm sleep disorders.

Extinction

involves the removal of the positive reinforcement for the child's resistance to go to bed and awakenings by ignoring demands for attention. The child is placed in its bed and ignored pending sleep onset.

Graded extinction

follows the same principle as extinction, but involves the gradual withdrawal of parental attention. It may be recommended that parents respond to the child's cries at lengthening intervals to teach the child to soothe itself to sleep. For example, parents may initially respond to cries after 2 minutes, then on the next occasion after 4 minutes and so on to a maximum of 20 minutes. Alternatively, parents may gradually increase the physical distance between themselves and the child. For example, the parent may start off sitting next to the child's bed, then on the second night move 30 cm away and so on until the parent is outside the child's room.

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Parasomnias

are undesirable phenomena (physical or behavioural events) that occur predominantly during sleep. They can include nightmares, sleep terror disorder, and sleepwalking.

Scheduled waking

is based on the rationale that by systematically waking the child before they usually awake the likelihood of spontaneous awakenings is reduced. The frequency of the scheduled wakes is gradually reduced and eventually discontinued.

Sleep hygiene

, also referred to as positive routines, is an umbrella term for several modifications to the environment, and to behaviour that parents would perform in order to prepare their child for sleep in a more effective way. Examples include: removing caffeine from the child's diet, a short regular routine leading up to bed, ensuring the bedroom environment is conducive to sleep (dark, quiet, comfortable, no extreme temperatures), and avoiding boisterous play immediately before bedtime.

Sleep latency

is the time between going to bed and going to sleep.

Sleep restriction

is intended to increase the sleep efficiency of the child (the ratio of total sleep time to time spent in bed). The child is only allowed in bed when sleeping and the time allowed in bed is gradually increased. This increases the association of being asleep and being in bed.

Very low-quality evidence

Any estimate of effect is very uncertain.

Insomnia in the elderly

Nocturnal enuresis

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients.To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Contributor Information

Paul Montgomery, University of Oxford, Oxford, UK.

Danielle Dunne, Queen Mary, University of London, London, UK.

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BMJ Clin Evid. 2007 Sep 1;2007:2304.

Extinction and graduated extinction for dysomnia

Summary

SLEEP DURATION Compared with placebo: Sleep programmes (behavioural advice booklet based on extinction plus support from staff) and behavioural advice booklets may be more effective than placebo at improving sleep and reducing the number of weekly night wakes in otherwise healthy children who regularly wake up in the night ( low-quality evidence ). Sleep programme compared with behavioural advice booklet: Sleep programme may be no more effective than behavioural advice booklet in improving sleep or reducing the number of weekly night wakes in otherwise healthy children who regularly wake up in the night ( very low-quality evidence ). Compared with placebo: Graduated extinction-based behavioural programme supported with therapist's telephone calls may be more effective in improving sleep after 3 months of treatment in children with severe learning disabilities and severe sleep problems compared with placebo (very low-quality evidence). Graduated extinction plus sleep hygiene compared with placebo: Graduated extinction plus sleep hygiene-based therapy or booklet treament may be more effective in improving sleep in children with severe learning disabilities and severe sleep problems at 6 weeks compared with placebo (low-quality evidence). BEDTIME TANTRUMS Graduated extinction compared with placebo: Graduated extinction may be more effective in reducing the number and duration of bedtime tantrums compared with placebo in otherwise healthy children ( low-quality evidence ). Compared with sleep hygiene: Graduated extinction may be no more effective in reducing the number and duration of bedtime tantrums compared with sleep hygiene in otherwise healthy children (very low-quality evidence). NOTE We found no clinically important results about graduated extinction compared with sleep hygiene in the treatment of children with physical or learning disabilities.

Benefits

Extinction and graduated extinction versus placebo in otherwise healthy children:

We found one systematic review (search date 2000, 2 RCTs, 81 children) that did not include a meta-analysis for the clinical outcomes of interest, and one additional RCT. The first RCT identified by the review (45 children aged 9–60 months who regularly woke in the night) found that both a sleep programme (behavioural advice booklet based on extinction plus support from staff) and the behavioural advice booklet alone significantly reduced the number of weekly night wakes (as recorded by the child's mother) compared with waiting list control at 4 weeks (6.9 with sleep programme v 4.9 with booklet only v 11.7 with waiting list control; P less than 0.05 for each treatment v control). The RCT found no significant difference in the number of weekly night wakes between the sleep programme compared with behavioural advice booklet alone (P value not reported). The second RCT identified by the review (36 children aged 18–48 months who were having about 5 bedtime tantrums/week before treatment) compared three interventions: graduated extinction, sleep hygiene, and placebo (see table 1 ). It found that, compared with placebo, children receiving graduated extinction had significantly less-frequent and shorter bedtime tantrums, as reported by the parents, during the 6 weeks of treatment (absolute results presented graphically; P less than 0.05), and at 3 and 6 weeks' follow-up (absolute results presented graphically; P less than 0.001). We found one additional RCT (49 children aged 16–48 months with at least 4 difficult bedtimes/week [taking at least 30 minutes to settle or not settling alone], 4 difficult night times/week [child waking in the night and not resettling without the parent, or sleeping in the parental bed], or both) (see table 1 ). It found that both extinction and graduated extinction significantly improved mean settling score (“good bedtimes” = number of bedtimes/week that the child settled in less than 10 minutes) and mean sleeping score (“good night times” = number of nights/week that the child slept through without sleeping with or waking up the parents) compared with waiting list control at 3 weeks (good bedtimes: 5.36 with extinction v 4.92 with graduated extinction v 0.62 with waiting list control; P = 0.0005 for each treatment v waiting list control; good night times: 3.43 with extinction v 4.91 with graduated extinction v 0.88 with waiting list control; P = 0.0005 for each treatment v waiting list control). However, the difference between extinction and graduated extinction was not significant (P value not reported).

Table 1.

Detailed descriptions of treatments in some included RCTs.

Ref Intervention/population Description
  Standardised sleep programme (based on extinction) 8 page booklet — “Parent Guide” (that involved organised bedtime routines, procedures for settling the child, and for the handling of crying, calling out, and getting out of bed) plus a 1-hour interview Telephone calls each day at first, then as needed Total staff attention: 2–3 hours/family
  Written guide for parents 8-page booklet — “Parent Guide” (that involved organised bedtime routines, procedures for settling the child, and for the handling of crying, calling out and getting out of bed) plus any questions answered Total staff attention: 5–10 minutes/family
  Sleep hygiene Therapist selects ideal bedtime for the child Parents construct a “positive routine” of 4–7 quiet activities to last up to 20 minutes, with praise after each completed routine Routine consists of, for example, teeth brushing, using the toilet, reading a short story, the parent helping the child into pyjamas, the parent gently scratching and massaging the child's back Child told to go to sleep after routine If the child left the bed or had tantrums after the routine is completed, the parent had to lift the child over the parent's back and tell the child firmly, “The routine is over; it is time for bed!” Each week the routine began 5–10 minutes earlier, so that, by the fifth week, the routine finished at the time the parent(s) had originally attempted to establish bedtime
  Graduated extinction Parents were told to maintain the child's established bedtime Parents were told to ignore the child's tantrums for specific time intervals, depending on the child's age and the time the parents thought they could ignore the child The parents were allowed to comfort their child for 15 seconds after each time interval, and then leave the room If the child left the bed, it was told, “No, it is time for you to go to sleep” The time intervals were increased weekly
  Placebo Control group were told to continue what they already do when the child has a tantrum, and that some children “grow out” of bedtime tantrums
  Extinction Parents put the child to bed after pre-bedtime routines, said “good night”, left the room, and did not return Parents could check the child briefly in the night if they work, then leave and not return If the child left the bedroom, they were given 1 warning each night If the child left the bedroom a second time, they were kept in the room by the parents by closing the door or using a child gate. The door was kept closed until the child was asleep Parents explained the routine to the child before treatment, and the child's successful behaviour was rewarded with praise and small rewards
  Graduated extinction Parents put the child to bed after pre-bedtime routines, said “good night”, and left the room If the child cried or fussed, the parents could make a brief (30 seconds) check after 5 minutes, then left the room Brief checks could be made after another 10 minutes, then at 15-minute intervals if the child was still crying No checks were made after the child stopped crying Checking intervals were lengthened by 5 minutes each night If the child left the bedroom, it was given 1 warning each night If the child left the bedroom a second time, the parent held the door closed for a short interval each time. The intervals were progressively lengthened until the child stayed in bed. Once the child stayed in bed, the door was left open Parents explained the routine to the child before treatment, and the child's successful behaviour was rewarded with praise and small rewards
  Severe sleep problem definition Night waking at least 3 times/week for more than a few minutes with disturbing of the parents Settling problems at least 3 times/week with the child taking at least 1 hour to settle, and disturbing the parents Symptoms for at least 3 months, and not explicable by pain
  Brief treatment (booklet — gradual extinction and sleep hygiene) Parents were given a simple booklet which dealt with: outline of normal sleep introduction of behavioural techniques how to monitor the child's behaviour good sleeping habits specific techniques to change undesirable behaviour: ignoring the child during settling, and checking on the child only at increasing intervals, and decreasing the contact between the child and the parent during the undesirable behaviour; avoiding letting the child sleep in the parents' bed; and rewarding desirable behaviour
  Conventional treatment Parents were given the same advice as in the booklet, but in a face-to-face interview
  Crossover control group Parents were given no intervention for the first 6 weeks, then were re-randomised to a treatment group
  Sleep problem definition Settling was severe if the child took at least 1 hour to settle and fall asleep, if the parents were disturbed in this time, and if the settling problems occurred at least 3 times/week Night waking was severe if the child woke for more than a few minutes and disturbed the parents, or went into their room or bed, and if this happened at least 3 times/week early waking was severe if the child woke up before 5 am at least 3 times/week
  Challenging behaviour definition A child was included if they had any item on the Aberrant Behavior Checklist scored as quite serious or severe
  Treatment (extinction and gradual extinction) The therapist discussed certain techniques with the parent: extinction and graduated extinction procedures such as checking and gradual withdrawal, and stimulus-control procedures and positive reinforcement

Graduated extinction versus sleep hygiene in otherwise healthy children:

See benefits of sleep hygiene.

Graduated extinction versus sleep hygiene in children with physical or learning disabilities:

We found no systematic review or RCTs.

Graduated extinction plus sleep hygiene versus placebo in children with physical or learning disabilities:

One RCT (66 children aged 2–8 years with any form of severe learning disability and severe sleep problems (see table 1 )) found that both graduated extinction plus sleep hygiene-based therapist or booklet treatment reduced Composite Sleep Disturbance Score compared with control group at 6 weeks (2.40 with therapist v 2.55 with booklet v 5.75 with control group; P less than 0.001 for either treatment v control group). The RCT reported that it was underpowered to measure a difference between the therapist and booklet. The Composite Sleep Disturbance Score scored the children on: settling frequency, settling duration, night waking frequency, and night waking duration.

Extinction and graduated extinction versus placebo in children with physical or learning disabilities:

One RCT (30 children, mean age 10 years with any severe learning disability, and a severe sleep problem, and one form of a daytime challenging behaviour (see table 1 )) compared an individually tailored graduated extinction-based behavioural programme supported with therapist telephone calls versus no treatment. The RCT found that therapist treatment significantly reduced mean Composite Sleep Index Score compared with no treatment post-treatment and at 3 months' follow-up (post-treatment: 6.62 with therapist treatment v 3.79 with no treatment; P = 0.001; 3 months: 6.29 with therapist treatment v 2.96 with no treatment; P = 0.001). The Composite Sleep Index Score covered the frequency and duration of settling and night wakings, could range from 0 (worst) to 12 (best), and was measured by parental questionnaire. The RCT also reported that the mothers' sleep period was significantly improved with treatment compared with no treatment at 3 months' follow-up (+0.3 hours with therapist treatment v –0.4 hours with no treatment; P = 0.03), whereas there was no significant difference between the children's sleep periods (+0.2 hours with therapist treatment v +0.4 hours with control; P value not reported).

Harms

Extinction and graduated extinction versus placebo in otherwise healthy children:

The systematic review did not report on adverse effects. The additional RCT found only positive side effects, such as reports of less verbose discipline, decreased stress in parents, and improved parent–child relationships.

Graduated extinction versus sleep hygiene in otherwise healthy children:

See harms of sleep hygiene.

Graduated extinction versus sleep hygiene in children with physical or learning disabilities:

See harms of sleep hygiene.

Graduated extinction plus sleep hygiene versus placebo in children with physical or learning disabilities:

The RCT did not report adverse effects.

Extinction and graduated extinction versus placebo in children with physical or learning disabilities:

The RCT did not report adverse effects.

Comment

Extinction and graduated extinction versus placebo in otherwise healthy children:

One RCT found that a predictor of compliance and outcome with extinction treatment is stress about parenting and depression — mothers who were less depressed and stressed about parenting tended to have better outcomes with extinction. No such predictor was found for graduated extinction. The RCT also achieved positive results with about 3 hours of therapist contact per person, suggesting brief treatments can be effective. The effective use of a booklet-based treatment suggests that therapist contact may not be necessary.

Extinction and graduated extinction versus placebo in children with physical or learning disabilities:

The second RCT included children with a mix of disabilities in its sample. It might have been preferable to use a sample of children with the same specific form of disability, as opposed to a mixture, or to conduct a subgroup analysis to ascertain whether treatment is more or less effective in certain types of disability. Treatment for the children's sleep problem seems to have had more beneficial effects on the mothers' sleep patterns than on their children's. The disparity between the results of the objective and subjective sleep measures could be because the treatment may have affected the children's signalling of their awake state to the parents, rather than their sleep quality or quantity. This may account for the improvement in the mothers' sleep. Alternatively, the authors suggest that the discrepancy may be because the objective variables used were primarily concerned with restlessness.

Clinical guide:

These findings are based on studies conducted over short periods of time. Longer-term studies are required to assess the sustainability of the results of this treatment. We have not separated extinction and graded extinction here, because combining these two reflects practise more accurately — as they are often used in combination, and because people change from extinction to graduated extinction mid-treatment. Extinction can be upsetting to parents, and may not meet with consistent parental compliance, and this may lead to reinforcement of the negative behaviour. Graded extinction may be less distressing for parents, and thus may be a more acceptable treatment option.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Sleep hygiene for dysomnia in otherwise healthy children

Summary

BEDTIME TANTRUMS Compared with placebo: Sleep hygiene may be more effective in reducing the number and duration of bedtime tantrums in otherwise healthy children at 6 weeks compared with placebo ( very low-quality evidence ). Compared with graduated extinction: Sleep hygiene may be no more effective in reducing the number and duration of bedtime tantrums compared with graduated extinction in otherwise healthy children ( very low-quality evidence ).

Benefits

Sleep hygiene versus placebo:

We found one systematic review (search date 2000, 1 RCT). The RCT identified by the review (36 children aged 18–48 months who were having about 5 bedtime tantrums/week before treatment) compared three interventions: graduated extinction, sleep hygiene, and placebo. It found that, compared with placebo, children receiving sleep hygiene treatment had tantrums before bedtime and settling problems less frequently and for shorter periods during the 6 weeks of treatment (results presented graphically; P less than 0.05), and at 3 and 6 weeks' follow-up, (results presented graphically; P less than 0.001) as reported by their parents (see table 1 ). The RCT also found that the parents' marital satisfaction (measured as the difference in the pre- and post-Dyadic Adjustment Scale) was significantly improved with sleep hygiene compared with placebo (data not reported; P less than 0.02).

Sleep hygiene versus graduated extinction:

The RCT found similar improvements in the frequency and duration of tantrums before bedtime with sleep hygiene and graduated extinction (results presented graphically; significance not reported).

Harms

Sleep hygiene versus placebo:

The systematic review and RCT did not report on harms.

Sleep hygiene versus graduated extinction:

The RCT did not report on harms.

Comment

Clinical guide:

This simple non-invasive set of options for parents should be a front-line treatment for sleep problems in children, especially in view of the difficulties some parents have with extinction methods.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Sleep hygiene for dysomnia in children with physical or learning disabilities

Summary

SLEEP DURATION Sleep hygiene plus graduated extinction compared with placebo: Sleep hygiene-based therapy or booklet treament plus graduated extinction may be more effective in improving sleep duration in children with severe learning disabilities and severe sleep problems at 6 weeks compared with placebo ( low-quality evidence ). NOTE We found no direct results about the effects of sleep hygiene alone in the treatment of children with physical or learning disabilities.

Benefits

Sleep hygiene alone versus other treatments/placebo in children with physical or learning disabilities:

We found no systematic review or RCTs.

Sleep hygiene plus graduated extinction versus other treatments/placebo in children with physical or learning disabilities:

See benefits of extinction.

Harms

Sleep hygiene plus graduated extinction versus other treatments/placebo:

See harms of extinction.

Comment

Clinical guide:

This simple non-invasive set of options for parents should be a front-line treatment for sleep problems in children, especially in view of the difficulties some parents have with extinction methods. For children with behavioural or learning difficulties, sleep hygiene is often used in conjunction with other behavioural treatments.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Melatonin for dysomnia in otherwise healthy children

Summary

SLEEP DURATION Compared with placebo: Melatonin may be more effective than placebo in improving sleep-onset time and total sleep time in otherwise healthy children ( very low-quality evidence ). NOTE Little is known about the long-term effects of melatonin, and the quality of the product purchased could be variable as melatonin is classified as a food supplement.

Benefits

Melatonin versus placebo:

We found two systematic reviews, which identified the same RCTs (search date 2003, 2 RCTs, 102 children aged 6–12 years with sleep-onset insomnia (sleep-onset insomnia was defined as sleep onset later than 8.30 pm in children aged 6 years, then 15 minutes later a year until 12 years old; time from lights off until sleep had to be more than 30 minutes; more than 4 nights/week for more than 1 year.) The first reviewperformed a meta-analysis for sleep-onset latency, and found a significant difference between melatonin and placebo; however, this result was clinically insignificant (2 RCTs, 102 children; point estimate –16.7 mins, 95% CI –29.4 to –4.0; hererogeneity = 0; P = 0.0008). The first included RCT (40 children aged 6–12 years with sleep-onset insomnia) found that melatonin 5 mg significantly improved mean time of sleep onset (9.09 pm [–1 hour 9 minutes] with melatonin v 10.06 pm [+45 minutes] with placebo; P = 0.005) and total sleep time (9 hours 43 minutes with melatonin v 9 hours 14 minutes with placebo; P = 0.026) compared with placebo at 4 weeks. However, it found no significant difference between melatonin and placebo for sleep latency (34.5 minutes with melatonin v 48.8 minutes with placebo; P = 0.128) and wake up time (7.22 am [–24 minutes] with melatonin v 7.21 am [–1 minutes] with placebo; P = 0.144). Lights-off time and wake-up time were recorded by the parents; sleep latency and total sleep time were estimated; sleep onset was measured by actigraphy. The second included RCT (62 children aged 6–12 years with sleep onset insomnia) found that melatonin 5 mg improved mean time of sleep onset (21.00 hours [–1 hour 7 minutes] with melatonin v 21.54 hours [–10 minutes] with placebo, wake-up time (7.32 hours [–19 minutes] with melatonin v 7.43 hours [+7 minutes] with placebo), sleep latency (27 minutes with melatonin v 41 minutes with placebo), and general health (RAND-GHRI [General Health Rating Index]: 25.3 with melatonin v 24.6 with placebo; P values of comparisons between groups not reported) compared with placebo at 4 weeks. Sleep-onset time was monitored by the parents, and general health score was measured by questionnaire to the parents; however, methods of measurement of other outcomes were not clear. In this RCT, the proportion of children with attention deficit hyperactivity disorder (ADHD), and those receiving methylphenidate, was not similar between groups (melatonin group: 8/27 [30%] had ADHD, 6/27 [22%] took methylphenidate; placebo group: 20/35 [57%] had ADHD, 19/35 [54%] took methylphenidate; significance not reported). The second systematic review reported that methylphenidate has been associated with insomnia.

Harms

Melatonin versus placebo in otherwise healthy children:

The first RCT reported the development of mild generalised epilepsy in one child who took melatonin, during the course of the trial, after 4 months of melatonin. Additionally, two children developed mild headaches during the first 2 days of treatment. The second RCT reported adverse effects including cold feelings, decrease of appetite, dizziness, and decrease of mood after initial melatonin intake. However, these effects ceased after 3 days of treatment.

Comment

Little is known about the long-term effects of melatonin. To determine the effectiveness of this treatment on outcome measures other than sleep onset, more large-scale studies are needed. Additionally, the few studies we found (but excluded because of the small sample size [fewer than 20 people] or large attrition [greater than 80%]) based results on a short treatment span. Such methodological weaknesses need to be addressed in future trials.

In the first RCT included in the reviews, at the 18-month follow-up 13/38 (34%) children had ceased treatment because they no longer had a sleep problem, and only one child ceased treatment because of no improvement. Although this may suggest long-term effectiveness, such results are based on only one trial. Furthermore, little is known about the adverse effects of long-term use of melatonin. One review reported that, because research on the effects of melatonin has been carried out mostly in children with physical or learning disabilities, subtle adverse effects of melatonin may have escaped observation.

Clinical guide:

Data on melatonin dosages are scarce, particularly in children. However, there is some suggestion of receptor flooding at higher doses, and of efficacy at very low doses — although which children need the higher doses remains unclear. Since melatonin is classified as a food supplement rather than a drug, it is unlikely to be of “pharmaceutical grade” when purchased by consumers from the internet or from health food shops.

Substantive changes

Melatonin for dysomnias in otherwise healthy children One systematic review added,that identified no new RCTs. Categorisation unchanged: Trade-off between benefits and harms.

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Melatonin for dysomnia in children with physical or learning difficulties

Summary

SLEEP IMPROVEMENT Compared with placebo in children with epilepsy: Melatonin may be more effective in improving sleep in children with epilepsy compared with placebo ( very low-quality evidence ). Compared with placebo in children with attention deficit/hyperactivity disorder: Melatonin may be more effective in reducing sleep-onset times and increasing total night time sleep at 10 days compared with placebo ( very low-quality evidence ). NOTE Little is known about the long-term effects of melatonin, and the quality of the product purchased could be variable as melatonin is classified as a food supplement.

Benefits

Melatonin versus placebo in children with epilepsy:

We found no systematic review, but found two small RCTs. The first RCT (31 children aged 3–12 years with epilepsy who had been seizure free for the previous 6 months) found that melatonin (6 mg for children aged less than 9 years who weighed less than 30 kg; 9 mg for children aged more than 9 years who weighed greater than 30 kg; dose of melatonin outside these weight ranges for the age group not clear) significantly improved the total sleep score (see comment below) at 4 weeks compared with placebo (median improvement: 24% with melatonin v 14% with placebo; P = 0.005). However, there was no significant difference between the two groups in actual post-treatment total sleep score (median: 52.5 with melatonin v 55.0 with placebo; P = 0.76). The children were all taking sodium valproate monotherapy for their epilepsy. The second RCT (31 children aged 3 to 12 years with epilepsy who had been seizure-free for the previous 6 months; also taking carbamazepine; included on basis of epilepsy, not sleep disorder) also found that melatonin (same dosing as RCT above) significantly improved total sleep scores and reduced sleep problems at 4 weeks compared with placebo (percentage decrease in total sleep score: 8% with melatonin v 15% with placebo, P = 0.01; post-treatment median score: 54.5 with melatonin v 57.0 with placebo; P = 0.03). There was no significant difference between treatment and control groups on any of the other included measures — daytime drowsiness, parasomnias, or sleep fragmentation.

Melatonin versus placebo in children with attention defecit/hyperactivity disorder (ADHD):

We found no systematic review and one small RCT. The RCT (crossover: 10 days' treatment with 5-day washout period; 23 children aged 6–14 years with ADHD and initial insomnia greater than 60 minutes; 2/3 taking concomittant methylphenidate, 1/3 taking concomittant dextroamfetamine) found that melatonin (5 mg) significantly reduced sleep-onset latency compared with placebo over 10 days (measured using an actigraph; mean SOL: 46.4 minutes with melatonin v 62.1 minutes with placebo; P less than 0.01) Melatonin treatment also significantly increased total night-time sleep by 15 minutes compared with placebo (P less than 0.01).

Harms

Melatonin versus placebo in children with epilepsy:

The two RCTs reported that there were no adverse effects, and children remained seizure free during the 8 weeks. Reports have suggested that, because of the contraceptive properties of melatonin, such treatment could affect the onset of puberty. However, there seems to be conflicting evidence as to the effect melatonin has on seizures. One small cohort study found that seizure frequency increased in 4/6 (67%) of neurologically disabled children who took melatonin. Seizure activity returned to pre-treatment levels when the children discontinued melatonin.

Melatonin versus placebo in children with ADHD:

All reported adverse effects in the RCT were mild or moderate, with the exception of a migraine, which was rated as severe. No serious adverse events, or clinically significant changes in vital signs, or abnormalities were apparent on physical examination.

Comment

Little is known about the long-term effects of melatonin. To determine the effectiveness of this treatment on outcome measures other than sleep onset, more large-scale studies are needed. Additionally, the few studies we found (but excluded) because of the small sample size (fewer than 20 people) or large attrition (greater than 80%) based results on a short treatment span. Such methodological weaknesses need to be addressed in future trials.

Melatonin versus placebo in children with epilepsy:

The total sleep score was from the Sleep Behavior Questionnaire, which assessed the quantity and quality of sleep, usual bedtime and waking time, sleep latency, parental involvement at sleep onset, night waking, co-sleeping, night-time events, daytime drowsiness, and unrefreshing sleep. A decrease in score corresponds to fewer sleep problems.

Melatonin versus placebo in children with ADHD:

The results of this RCT suggest that short-term melatonin treatment may be effective in children with ADHD. As participants’ symptoms of insomnia returned on the cessation of melatonin treatment, further research is necessary to determine whether melatonin’s long-term effectiveness could be safely sustained.

Dosing of melatonin:

Data on melatonin dosages are scarce, particularly in children. However, there is some suggestion of receptor flooding at higher doses, and of efficacy at very low doses — although which children need the higher doses remains unclear. Since melatonin is classified as a food supplement rather than a drug, it is unlikely to be of “pharmaceutical grade” when purchased by consumers from the internet or from health food shops.

Substantive changes

Melatonin for dysomnias in children with physical or learning difficulties Two RCTs added; Categorisation unchanged: Unknown effectiveness.

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Antihistamines for dysomnia

Summary

We found no direct information about antihistamines in the treatment of children with dysomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Behavioural therapy plus benzodiazepines, or plus chloral and derivatives for dysomnia

Summary

We found no direct information about behavioural therapy plus benzodiazepines, or behavioural therapy plus chloral and derivatives (chloral hydrate, triclofos sodium) in the treatment of children with dysomnias.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Exercise for dysomnia

Summary

We found no direct information about exercise in the treatment of children with dysomnias.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

Clinical guide:

Although, intuitively, exercise would seem helpful for insomnia, there is a lack of evidence to support this theory.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Light therapy for dysomnia

Summary

We found no direct information about light therapy in treating children with dysomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Sleep restriction for dysomnia

Summary

We found no direct information about sleep restriction in the treatment of children with dysomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

Clinical guide:

Although, intuitively, sleep restriction would seem helpful for dysomnias, there is currently a lack of evidence to support this theory.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Antihistamines for parasomnia

Summary

We found no direct information about antihistamines in treating children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Behavioural therapy plus benzodiazepines, or plus chloral and derivatives for parasomnia

Summary

We found no direct information about behavioural therapy plus benzodiazepines, or behavioural therapy plus chloral and derivatives (chloral hydrate, triclofos sodium) in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Exercise for parasomnia

Summary

We found no direct information about exercise in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Extinction and graded approaches for parasomnia

Summary

We found no direct information about extinction and graded approaches in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Light therapy for parasomnia

Summary

We found no direct information about light therapy in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Melatonin for parasomnia

Summary

REDUCTION OF PARASOMNIA SCORES Compared with placebo: We don't know whether melatonin is effective in decreasing parasomnia scores in children with epilepsy ( very low-quality evidence ). NOTE We found no direct information about melatonin in the treatment of otherwise healthy children with parasomnia. ADVERSE EFFECTS Little is known about the long-term effects of melatonin, and the quality of the product purchased could be variable.

Benefits

Melatonin versus placebo in otherwise healthy children:

We found no systematic review or RCTs examining the effect of melatonin on otherwise healthy children with parasomnia.

Melatonin versus placebo in children with epilepsy:

We found no systematic review but found two RCTs . The first RCT (31 children aged 3–12 years with epilepsy who were seizure free for the previous 6 months; all taking concomittant sodium valproate) found that melatonin (6 mg for children aged less than 9 years who weighed less than 30 kg; 9 mg for children aged more than 9 years who weighed more than 30 kg; dose of melatonin outside these weight ranges for an unspecified age group) significantly decreased the median parasomnia score* at 4 weeks compared with placebo (60% decrease with melatonin v 36% decrease with placebo; P = 0.03). The second RCT (31 children aged 3–12 years with epilepsy who had been seizure free for the previous 6 months; all taking concomittant carbamazepine) found that melatonin (same doses as RCT above) had no significant effect on parasomnia score at 4 weeks compared with placebo (7.5 with melatonin v 7.5 with placebo).The children in both of these RCTs were included on the basis of their epilepsy, not any sleep disorder.

*The decrease in parasomnia score reflects the median percentage decrease of the parasomnia part of the Sleep Behavior Questionnaire.

Harms

Melatonin versus placebo in children with epilepsy:

No adverse effects were observed, and children remained seizure free during the 8 weeks of both RCTs. See also harms of melatonin for dysomnias in children.

Comment

See comment on melatonin for dysomnias in children.

Substantive changes

Melatonin for parasomnias in children with epilepsy One RCT added. Categorisation unchanged: Unknown effectiveness.

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Safety/protective interventions for parasomnia

Summary

We found no direct results about safety/protective interventions in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Scheduled waking for parasomnia

Summary

We found no direct information about scheduled waking in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

Clinical guide:

Intuitively, scheduled waking would seem to be a promising treatment; however, high-quality trials need to be conducted.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Sleep hygiene for parasomnia

Summary

We found no direct information about sleep hygiene in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs on sleep hygiene in children with parasomnia.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2007 Sep 1;2007:2304.

Sleep restriction for parasomnia

Summary

We found no direct information about sleep restriction in the treatment of children with parasomnia.

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence


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