Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn...

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Insomnia in Pediatrics: Insomnia in Pediatrics: Prevalence - Lit Prevalence - Lit Review, Office-Based Review, Office-Based Diagnoses & Drug Use Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office of Postmarketing Drug Risk Assessment Pediatric Advisory Subcommittee Meeting November 16, 1999

Transcript of Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn...

Page 1: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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Sleep Problem Visits Among Patients 0 to 16 Years of Age

IMS HEALTH NDTI 1993-1998

Page 11: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.

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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.

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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.

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.

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.

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Top 5 USC Drug Codes Mentioned with Sleep Problems, 0-16 Years of Age

IMS HEALTH NDTI 1993-1998

Page 16: Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based Diagnoses & Drug Use Carolyn McCloskey, MD, MPH & Amarilys Vega, MD, MPH FDA/CDER/Office.

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.

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