Insomnia in Pediatrics: Prevalence - Lit Review, Office-Based 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

Objectives of Presentation
Describe

for the pediatric population:

of insomnia (literature)

Prevalence Types Drug

of sleep problem diagnoses

use for sleep problems

Interpretation of the literature

Definition(s)

of insomnia/sleep problems Methodology of data collection:

Questionnaire:

Parental vs child questionnaire Polysomnography

Confounding
Child:

factors:

age/development, bed routines, allergies or medical conditions, etc. Family: parental habits, expectations, etc. Environmental: noise, light, etc.

Insomnia - Literature Review Prevalence Rates

Sleep Problem Age Chronic Poor Sleepers1 12-18 yo Poor sleep2 15-20 yo
Sleeping poorly3 8-10 yo

Prevalence 12% 13%M 17%F 14% 43% 40.8%

Med 4.6% 10%

4%

Sleep difficulties3 Sleep disturbance4

1

8-10 yo high sch

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Levy 1986, 2 Patois 1993, 3 Kahn 1989, 4 Vignau 1997

Insomnia - Literature Review Prevalence Rates

Blader

1997: 5-12 yo, 987 NY children

27% 17% 17% 11% 6.5%

Bedtime

resistance Morning wake-up probs Fatigue complaints Sleep-onset delays Night waking

Insomnia - Literature Review Prevalence Rates

Rona

1998: 14,372 Eng & Scot children

problems 5 yo 20% 11 yo 6%

Sleep

Disturbed

sleep >1/week 5 yo 4% 9 yo 1%

<25%

consulted a physician

IMS HEALTH

National Disease and Therapeutic Index (NDTI)

Survey

of 2,930 office-based practices in Continental

USA Systematic stratified sample of physicians & physicians work days Provides demographic, diagnostic and drug use data Representative sample

IMS HEALTH NDTITM

Data Retrieval Methods

Diagnostic
ICD-9

Codes

& NDTI Codes Specific Disorders of Sleep of Nonorganic Origin

NDTI:

Insomnia subgroup
Insomnia subgroup

Sleep

Disturbances (excluding nonorganic)

NDTI:

Sleep Problems = ALL sleep disorders & disturbances

Pediatric Population Identified

IMS HEALTH NDTI

1993-1998
Pediatric Sample Size U.S. Pediatric Extrapolated Estimate 745,000

Sleep Problem (all types) Visits Total Visits

177

312,532

1,288,564,000

Sleep Problem Visits Among Patients 0 to 16 Years of Age IMS HEALTH NDTI 1993-1998

500

Diagnosis Visits (in thousands)

450 400 350 300 250 200 150 100 50 0 0 to 6 Years 7 to 16 Years

Types of Sleep Problem Visits Reported Among Patients 0-6 Years of Age IMS HEALTH NDTI 1993-1998
500 450 400

Diagnosis Visits (in thousands)

350 300 250 200 150 100 50 0 Total Disturbances Other Sleep of Sleep NOS Disorders Insomnia

Types of Sleep Problem Visits Reported Among Patients 7 to 16 Years of Age IMS HEALTH NDTI 1993-1998
300 250

Diagnosis Visits (in thousands)

200 150 100 50 0

Total Insomnia Disturbances of Sleep NOS Other Sleep Disturbances

Summary of Sleep Problem Visits 0-16 Years of Age

IMS HEALTH NDTITM All Sleep Problem Visits
0.05%

(5 in 10,000) of all pediatric visits Severity: 58% mild/mod, 36% unspec, 7% severe
Disturbances
0.03%

of Sleep NOS

(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

Drug Mentions for Pediatric Sleep Problem Visits 0-16 Years of Age
IMS HEALTH NDTITM 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

Top 5 USC Drug Codes Mentioned with Sleep Problems, 0-16 Years of Age IMS HEALTH NDTI 1993-1998
35

Percentage of All Drugs Mentioned

30
for Sleep Disorder Visits

25 20 15 10 5 0

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Top 10 Drugs Mentioned with All Types of Sleep Problems (0-16 Years of Age) IMS HEALTH NDTITM 1993-1998
Diphenhydramine Chloral

Hydrate Imipramine Promethazine Hydroxyzine Temazepam Clonidine Zolpidem Amitriptyline Sertraline

20% 13% 10% 8% 8% 6% 6% 4% 4% 4%

Summary of Data
IMS HEALTH NDTI Overall numbers are very small Most frequently reported Sleep Problems
Disturbances
Frequently

of Sleep NOS

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

diphenhydramine

Mostly