In the Highly Genericized Insomnia Market, What Opportunities Remain for New Therapies?

We expect the prevalence of insomnia in the seven major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) to approach 58 million cases by 2022; in 2012, the total number of prevalent cases was 54 million. Although not all patients who experience symptoms of insomnia seek professional medical care, interviewed experts report that those who do and who are prescribed pharmacological treatment could benefit from additional therapeutic options. However, emerging insomnia therapies will enter a market containing many well-established, relatively inexpensive first-line therapies and a growing generics presence. As a result, emerging therapies attempting to attain a premium price in this market will need to offer substantial improvements in efficacy, safety and tolerability, and/or delivery over currently available therapies to achieve commercial success.

Questions Answered in This Report:

  • Improvement in patient-reported quality of sleep and increase in total sleep time are key goals in the treatment of insomnia. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European psychiatrists weight specific efficacy end points and other drug attributes in their prescribing decisions for insomnia?

  • Eszopiclone (Dainippon Sumitomo/Sunovion Pharmaceuticals/Eisai’s Lunesta) is the 2012 major-market sales leader for insomnia. What weaknesses exist in its profile that would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated potential on the attributes that surveyed psychiatrists indicate are the most important in their prescribing decisions? Which emerging therapies, if any, will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  • Based on its clinical profile, eszopiclone is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge eszopiclone as the future gold standard in 2017 or 2022?


Attributes included in conjoint analysis based assessment of target product profiles for insomnia:

- Reduction in latency to persistent sleep.

- Improvement in total sleep time.

- Reduction in time awake after sleep onset.

- Percentage of patients reporting next-day sleepiness.

- Percentage of patients reporting hallucinations.

- Scheduling status.

- Price/day.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for insomnia:

- Improved latency to persistent sleep.

- Increased total sleep time.

- Reduced time awake after sleep onset.

- Fewer patients reporting next-day sleepiness.

Physicians surveyed: 60 U.S. and 31 European psychiatrists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Eszopiclone (Dainippon Sumitomo/Sunovion Pharmaceuticals/Eisai’s Lunesta)

- Zolpidem CR (Sanofi’s Ambien CR/Stilnox CR, generics)

- Doxepin (low-dose; Somaxon Pharmaceuticals’ Silenor, generics)

- Ramelteon (Takeda Pharmaceutical’s Rozerem)

- Zaleplon (Pfizer’s Sonata, generics)

Emerging Therapies

- Suvorexant (Merck & Co.’s MK-4305)

- Tasimelteon (Vanda Pharmaceuticals’ Hetlioz [VEC-162])

- Filorexant (Merck & Co.’s MK-6096)

- Piromelatine (Neurim Pharmaceuticals’ Neu P-11)