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Slide 1 - 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
Slide 2 - Objectives of Presentation Describe for the pediatric population: Prevalence of insomnia (literature) Types of sleep problem diagnoses Drug use for sleep problems
Slide 3 - 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.
Slide 4 - Insomnia - Literature ReviewPrevalence 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
Slide 5 - Insomnia - Literature ReviewPrevalence 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%
Slide 6 - Insomnia - Literature ReviewPrevalence 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
Slide 7 - IMS HEALTH National Disease and 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
Slide 8 - 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
Slide 9 - Pediatric Population Identified IMS HEALTH NDTI™1993-1998
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Slide 13 - Summary of Sleep Problem Visits0-16 Years of AgeIMS 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
Slide 14 - Drug Mentions for Pediatric Sleep Problem Visits 0-16 Years of AgeIMS 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
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Slide 16 - 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%
Slide 17 - Summary of Data 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
 

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