Therapeutic Market Outlooks

Insomnia
Publication Date: January 2008

Table of Contents

Disease Etiology................................................................... 5
Possible Causes of Insomnia ............................................ 5
Insomnia Sub-Types ....................................................... 5
Primary Insomnia ..................................................... 5
Co-Morbid Insomnia.................................................. 5
Epidemiology & Patient Population Estimates........................... 6
Theoretical Patient Population.......................................... 6
Addressable Patient Population ........................................ 8
Treated Patient Population .............................................. 8
Insomnia Patient Population Model ................................... 9
U.S. Insomnia Market, 2004-2013 ........................................ 10
Disease & Market Definitions ......................................... 10
Forecasting Methodology............................................... 10
Market Revenue Forecasts............................................. 11
U.S. Insomnia Market Model, 2004-2013......................... 13
AVOS Physician Panel Results .............................................. 15
Physician Treatment Patterns......................................... 15
Patient Compliance ....................................................... 17
Non-Compliance Drivers .......................................... 17
High Cost of Therapy ........................................ 17
Negative Side Effects......................................... 17
Results Achieved Quickly ................................... 17
Delay in Achieving Desired Outcome ................... 17
Physician Product Selection Criteria ................................ 18
Past Product Experience .......................................... 18
Safety Profile ......................................................... 18
Patient Input.......................................................... 18
Availability of Samples............................................. 18
Long-Term Use ...................................................... 18
Cost of Therapy...................................................... 18
Differentiation ........................................................ 18

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 Physician Product Ratings.............................................. 18
Market Overview ................................................................ 21
Leading Products.......................................................... 22
Market History ............................................................. 22
Current Market Environment.......................................... 23
Access/Formulary Changes ...................................... 23
Therapeutic Substitution.......................................... 23
Impact on Promotion .............................................. 23
Future Market Environment ........................................... 24
Increased Prevalence .............................................. 24
Increased Awareness .............................................. 24
Introduction of Novel Drugs..................................... 24
Tighter Managed Care Coverage .............................. 24
Reduction in DTC Spending ..................................... 24
Increased FDA Scrutiny ........................................... 24
Launch of New Drug Classes.................................... 24
Prospects for Future Therapies ...................................... 25
Product Profiles
Ambien/Ambien CR....................................................... 27
U.S. Perspective ..................................................... 27
Worldwide Perspective ............................................ 28
AVOS Physician Panel Discussions ............................ 28
Zolpidem/zolpidem CR .................................................. 29
U.S. Perspective ..................................................... 29
Worldwide Perspective ............................................ 30
AVOS Physician Panel Discussions ............................ 30
Sonata/zaleplon ........................................................... 31
U.S. Perspective ..................................................... 31
Worldwide Perspective ............................................ 32
AVOS Physician Panel Discussions ............................ 32
Lunesta/eszopiclone ..................................................... 33
U.S. Perspective ..................................................... 33
Worldwide Perspective ............................................ 34
AVOS Physician Panel Discussions ............................ 34
Rozerem...................................................................... 35
U.S. Perspective ..................................................... 35
Worldwide Perspective ............................................ 36

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 AVOS Physician Panel Discussions ............................ 36
Restoril/temazepam...................................................... 37
U.S. Perspective ..................................................... 37
Worldwide Perspective ............................................ 38
AVOS Physician Panel Discussions ............................ 38
Indiplon ...................................................................... 39
U.S. Perspective ..................................................... 39
Worldwide Perspective ............................................ 40
Silenor ........................................................................ 41
U.S. Perspective ..................................................... 41
Worldwide Perspective ............................................ 42
Eplivanserin/Volinanserin............................................... 43
U.S. Perspective ..................................................... 43
Worldwide Perspective ............................................ 44
ORG 50081.................................................................. 45
U.S. Perspective ..................................................... 45
Worldwide Perspective ............................................ 46
Almorexant.................................................................. 47
U.S. Perspective ..................................................... 47
Worldwide Perspective ............................................ 48
Drugs in Development ........................................................ 49
R&D Overview ............................................................. 49
Non-Benzodiazepine GABA-A Agonists....................... 49
Serotonin Therapies................................................ 49
Orexin Antagonists ................................................. 49
Histamine Antagonists............................................. 49
Melatonin Receptor Agonists .................................... 49
Assessment of R&D Success Rates ................................. 50
Products in the Pipeline................................................. 51
Phase III (Nine Agents)........................................... 51
Phase II (10 Agents)............................................... 52

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