Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn...
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![Page 1: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/1.jpg)
Insomnia in Pediatrics:Insomnia in Pediatrics:Prevalence - Lit Review, Prevalence - Lit Review,
Office-Based Diagnoses & Office-Based Diagnoses & Drug UseDrug Use
Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH
FDA/CDER/Office of Postmarketing Drug Risk Assessment
Pediatric Advisory Subcommittee Meeting
November 16, 1999
![Page 2: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/2.jpg)
Objectives of PresentationObjectives of Presentation
Describe for the pediatric population:
Prevalence of insomnia (literature)
Types of sleep problem diagnoses
Drug use for sleep problems
![Page 3: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/3.jpg)
Interpretation of the literatureInterpretation of the literature
Definition(s) of insomnia/sleep problems Methodology of data collection:
Questionnaire: Parental vs child questionnaire Polysomnography
Confounding factors: Child: age/development, bed routines, allergies or
medical conditions, etc. Family: parental habits, expectations, etc. Environmental: noise, light, etc.
![Page 4: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/4.jpg)
Insomnia - Literature ReviewInsomnia - Literature ReviewPrevalence RatesPrevalence Rates
Sleep Problem Age Prevalence Med
Chronic Poor Sleepers1 12-18 yo 12% 4.6%
Poor sleep2 15-20 yo 13%M 10%
17%F
Sleeping poorly3 8-10 yo 14% 4%
Sleep difficulties3 8-10 yo 43% --
Sleep disturbance4 high sch 40.8% --
1 Levy 1986, 2 Patois 1993, 3 Kahn 1989, 4 Vignau 1997
![Page 5: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/5.jpg)
Insomnia - Literature ReviewInsomnia - Literature ReviewPrevalence Rates Prevalence Rates
Blader 1997: 5-12 yo, 987 NY children
Bedtime resistance 27% Morning wake-up probs 17% Fatigue complaints 17% Sleep-onset delays 11% Night waking 6.5%
![Page 6: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/6.jpg)
Insomnia - Literature ReviewInsomnia - Literature ReviewPrevalence RatesPrevalence Rates
Rona 1998: 14,372 Eng & Scot children
Sleep problems 5 yo 20%
11 yo 6%
Disturbed sleep >1/week 5 yo 4% 9 yo 1%
<25% consulted a physician
![Page 7: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/7.jpg)
IMS HEALTHIMS HEALTH National Disease and National Disease and
Therapeutic Index (NDTI™)Therapeutic Index (NDTI™)
Survey of 2,930 office-based practices in Continental USA
Systematic stratified sample of physicians & physician’s work days
Provides demographic, diagnostic and drug use data Representative sample
![Page 8: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/8.jpg)
IMS HEALTH NDTIIMS HEALTH NDTITMTM Data Retrieval MethodsData Retrieval Methods
Diagnostic Codes ICD-9 & NDTI Codes
Specific Disorders of Sleep of Nonorganic Origin NDTI: Insomnia subgroup
Sleep Disturbances (excluding nonorganic) NDTI: Insomnia subgroup
“Sleep Problems” = ALL sleep disorders & disturbances
![Page 9: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/9.jpg)
Pediatric Population Identified Pediatric Population Identified IMS HEALTH NDTI™IMS HEALTH NDTI™
1993-19981993-1998PediatricSampleSize
U.S.Pediatric
ExtrapolatedEstimate
Sleep Problem(all types)Visits
177 745,000
Total Visits 312,532 1,288,564,000
![Page 10: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/10.jpg)
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0 to 6 Years 7 to 16 Years
Sleep Problem Visits Among Patients 0 to 16 Years of Age
IMS HEALTH NDTI 1993-1998
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Total Disturbancesof Sleep NOS
Other SleepDisorders
Insomnia
Types of Sleep Problem Visits Reported Among Patients 0-6 Years of Age
IMS HEALTH NDTI 1993-1998
![Page 12: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/12.jpg)
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Other SleepDisturbances
Types of Sleep Problem Visits Reported Among Patients 7 to 16 Years of Age IMS HEALTH NDTI 1993-1998
![Page 13: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/13.jpg)
Summary of Sleep Problem VisitsSummary of Sleep Problem Visits0-16 Years of Age0-16 Years of AgeIMS HEALTH NDTIIMS HEALTH NDTITMTM
All Sleep Problem Visits 0.05% (5 in 10,000) of all pediatric visits Severity: 58% mild/mod, 36% unspec, 7% severe
Disturbances of Sleep NOS 0.03% (3 in 10,000) of all pediatric visits 70% are single diagnosis visits
Insomnia 0.01% (1 in 10,000) of all pediatric visits 30% are single diagnosis visits 70% had a concomitant diagnosis such as fatigue,
headaches, etc
![Page 14: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/14.jpg)
Drug Mentions for Pediatric Sleep Drug Mentions for Pediatric Sleep Problem Visits 0-16 Years of AgeProblem Visits 0-16 Years of Age
IMS HEALTH NDTIIMS HEALTH NDTITMTM
All Sleep Problems Drug mentioned in 42% of visits
Disturbances of Sleep NOS - 32% mentioned drug Diphenhydramine Hydroxyzine
Insomnia - 73% of visits mentioned drug Imipramine Temazepam
![Page 15: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/15.jpg)
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Top 5 USC Drug Codes Mentioned with Sleep Problems, 0-16 Years of Age
IMS HEALTH NDTI 1993-1998
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Top 10 Drugs Mentioned with All Types of Top 10 Drugs Mentioned with All Types of Sleep Problems (0-16 Years of Age)Sleep Problems (0-16 Years of Age)
IMS HEALTH NDTIIMS HEALTH NDTITMTM 1993-1998 1993-1998 Diphenhydramine 20% Chloral Hydrate 13% Imipramine 10% Promethazine 8% Hydroxyzine 8% Temazepam 6% Clonidine 6% Zolpidem 4% Amitriptyline 4% Sertraline 4%
![Page 17: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.](https://reader035.fdocuments.in/reader035/viewer/2022072010/56649dd05503460f94ac6364/html5/thumbnails/17.jpg)
Summary of Data Summary of Data IMS HEALTH NDTI™IMS HEALTH NDTI™
Overall numbers are very small Most frequently reported Sleep Problems
Disturbances of Sleep NOS Frequently reported as a single diagnosis Mostly seen in patients <6 years
Insomnia Frequently reported concomitantly with other
problems
Drug Use for all types of Sleep Problems Mostly diphenhydramine