# Presentation: 487368

## 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:
- _Prevalence_ of insomnia (literature)
- Types of _sleep problem_ diagnoses
- _Drug 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 factors:
- Child:  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_		_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

## Insomnia - Literature Review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%

## Insomnia - Literature ReviewPrevalence 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

## IMS HEALTH National Disease and Therapeutic Index (NDTITM)

- 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

## IMS HEALTH NDTITM Data 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

## Pediatric Population Identified IMS HEALTH NDTITM1993-1998

## Slide 10

## Slide 11

## Slide 12

## 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 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

## 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

## Slide 15

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

- Diphenhydramine		20%
- Chloral Hydrate		13%
- Imipramine			10%
- Promethazine			  8%
- Hydroxyzine			  8%
- Temazepam			  6%
- Clonidine			  6%
- Zolpidem			  4%
- Amitriptyline			  4%
- Sertraline			  4%

## Summary of Data IMS HEALTH NDTITM

- 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