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

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 • Describe for the pediatric population: • Prevalence of insomnia (literature) • Types of sleep problem diagnoses • Drug use for sleep problems

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.

4. Insomnia - Literature ReviewPrevalence Rates Sleep ProblemAgePrevalenceMed Chronic Poor Sleepers112-18 yo12% 4.6% Poor sleep215-20 yo13%M10% 17%F Sleeping poorly38-10 yo14% 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

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%

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

7. IMS HEALTHNational 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

8. IMS HEALTH NDTITMData 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

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

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

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

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%

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