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

2. Objectives of Presentation u Describe for the pediatric population: u Prevalence of insomnia (literature) u Types of sleep problem diagnoses u Drug use for sleep problems

3. Interpretation of the literature u Definition(s) of insomnia/sleep problems u Methodology of data collection: u Questionnaire: Parental vs child questionnaire u Polysomnography u Confounding factors: u Child: age/development, bed routines, allergies or medical conditions, etc. u Family: parental habits, expectations, etc. u Environmental: noise, light, etc.

4. Insomnia - Literature Review Prevalence Rates Sleep ProblemAgePrevalenceMed Chronic Poor Sleepers 1 12-18 yo12%4.6% Poor sleep 2 15-20 yo 13%M10% 17%F Sleeping poorly 3 8-10 yo 14%4% Sleep difficulties 3 8-10 yo43%-- Sleep disturbance 4 high sch 40.8% -- 1 Levy 1986, 2 Patois 1993, 3 Kahn 1989, 4 Vignau 1997

5. Insomnia - Literature Review Prevalence Rates u Blader 1997: 5-12 yo, 987 NY children u Bedtime resistance27% u Morning wake-up probs17% u Fatigue complaints17% u Sleep-onset delays11% u Night waking 6.5%

6. Insomnia - Literature Review Prevalence Rates u Rona 1998: 14,372 Eng & Scot children u Sleep problems5 yo20% 11 yo 6% u Disturbed sleep >1/week5 yo4% 9 yo1% u <25% consulted a physician

7. IMS HEALTH National Disease and Therapeutic Index (NDTI™) u Survey of 2,930 office-based practices in Continental USA u Systematic stratified sample of physicians & physician’s work days u Provides demographic, diagnostic and drug use data u Representative sample

8. IMS HEALTH NDTI TM Data Retrieval Methods u Diagnostic Codes u ICD-9 & NDTI Codes u Specific Disorders of Sleep of Nonorganic Origin u NDTI: Insomnia subgroup u Sleep Disturbances (excluding nonorganic) u NDTI: Insomnia subgroup “Sleep Problems” = ALL sleep disorders & disturbances

9. Pediatric Population Identified IMS HEALTH NDTI™ 1993-1998

13. Summary of Sleep Problem Visits 0-16 Years of Age IMS HEALTH NDTI TM All Sleep Problem Visits u 0.05% (5 in 10,000) of all pediatric visits u Severity: 58% mild/mod, 36% unspec, 7% severe u Disturbances of Sleep NOS u 0.03% (3 in 10,000) of all pediatric visits u 70% are single diagnosis visits u Insomnia u 0.01% (1 in 10,000) of all pediatric visits u 30% are single diagnosis visits u 70% had a concomitant diagnosis such as fatigue, headaches, etc

14. Drug Mentions for Pediatric Sleep Problem Visits 0-16 Years of Age IMS HEALTH NDTI TM All Sleep Problems u Drug mentioned in 42% of visits u Disturbances of Sleep NOS - 32% mentioned drug u Diphenhydramine u Hydroxyzine u Insomnia - 73% of visits mentioned drug u Imipramine u Temazepam

16. Top 10 Drugs Mentioned with All Types of Sleep Problems (0-16 Years of Age) IMS HEALTH NDTI TM 1993-1998 u Diphenhydramine20% u Chloral Hydrate13% u Imipramine10% u Promethazine 8% u Hydroxyzine 8% u Temazepam 6% u Clonidine 6% u Zolpidem 4% u Amitriptyline 4% u Sertraline 4%

17. Summary of Data IMS HEALTH NDTI™ u Overall numbers are very small u Most frequently reported Sleep Problems u Disturbances of Sleep NOS u Frequently reported as a single diagnosis u Mostly seen in patients <6 years u Insomnia u Frequently reported concomitantly with other problems u Drug Use for all types of Sleep Problems u Mostly diphenhydramine