CLINICAL TRIALS PROFILE FOR SONATA

505(b)(2) Clinical Trials for Sonata

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00878553 ↗	Study of Sleep-maintenance Activity of 3 Doses of SKP-1041	Completed	INC Research Limited	Phase 2	2010-05-01	SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.
New Formulation	NCT00878553 ↗	Study of Sleep-maintenance Activity of 3 Doses of SKP-1041	Completed	Somnus Therapeutics, Inc.	Phase 2	2010-05-01	SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.

All Clinical Trials for Sonata

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00530101 ↗	The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity	Completed	Mallinckrodt	Phase 1	2004-07-01	The purpose of this research study is to evaluate MR imaging in subjects receiving doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA scans. This research study is expected to enroll approximately 10 subjects over 12 months at the University of Miami / Miller School of Medicine.
NCT00530101 ↗	The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity	Completed	University of Miami	Phase 1	2004-07-01	The purpose of this research study is to evaluate MR imaging in subjects receiving doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA scans. This research study is expected to enroll approximately 10 subjects over 12 months at the University of Miami / Miller School of Medicine.
NCT00694187 ↗	Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions	Completed	Roxane Laboratories	N/A	2004-01-01	The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

Clinical Trial Conditions for Sonata

Condition Name

Condition Name for Sonata
Intervention	Trials
Healthy	2
Short Term Treatment of Insomnia	2
Sleep	2

Condition MeSH

Condition MeSH for Sonata
Intervention	Trials
Sleep Initiation and Maintenance Disorders	3
Keratoconjunctivitis Sicca	1
Cardiotoxicity	1

Clinical Trial Locations for Sonata

Trials by Country

Trials by Country for Sonata
Location	Trials
United States	21
Korea, Republic of	1

Trials by US State

Trials by US State for Sonata
Location	Trials
Texas	5
Florida	2
California	1
Missouri	1
Tennessee	1

Clinical Trial Progress for Sonata

Clinical Trial Phase

Clinical Trial Phase for Sonata
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Sonata
Clinical Trial Phase	Trials
Completed	10

Clinical Trial Sponsors for Sonata

Sponsor Name

Sponsor Name for Sonata
Sponsor	Trials
Roxane Laboratories	2
Teva Pharmaceuticals USA	2
National Aeronautics and Space Administration (NASA)	1

Sponsor Type

Sponsor Type for Sonata
Sponsor	Trials
Industry	9
Other	3
U.S. Fed	1

SONATA: Clinical Trials, Market Analysis, and Projections

Introduction to SONATA

SONATA, also known as zaleplon, is a non-benzodiazepine hypnotic agent used for the short-term treatment of insomnia. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Clinical Trials Overview

SONATA has been extensively studied in various clinical trials to assess its efficacy and safety. These trials involved a significant number of patients, including elderly individuals, to evaluate its effectiveness in treating insomnia.

• Patient Population: Clinical trials included 3,435 patients with chronic insomnia, with 1,019 of these being elderly patients. Additionally, 264 patients were studied for transient insomnia[4].
• Dosing and Efficacy: SONATA was administered in doses of 5 mg, 10 mg, and 20 mg. The trials focused on decreasing sleep latency, with less emphasis on the duration of sleep and the number of awakenings. The drug was shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies[4].

Safety and Tolerability

• Side Effects: The trials also examined the time course of effects on memory and psychomotor function, as well as withdrawal phenomena. SONATA was generally well-tolerated, although it is contraindicated in patients who have experienced complex sleep behaviors or have hypersensitivity to zaleplon or its excipients[4].

Market Analysis

Current Market Size and Growth

The market for sleep disorder treatments, which includes drugs like SONATA, is growing steadily.

• Global Sleep Disorder Treatment Market: This market is expected to grow at a CAGR of 10.99% from $14.510 billion in 2021 to $30.102 billion by 2028[2].

Segmentation and Competition

• Drug Type: The sleep disorder treatment market is segmented by drug type, including benzodiazepines, non-benzodiazepines (like SONATA), antidepressants, and others. Non-benzodiazepines are a significant segment, given their preference over traditional benzodiazepines due to their lower risk of dependency and side effects[2].
• Competitive Landscape: The market includes major players such as Pfizer, Merck & Co., Sanofi SA, and Vanda Pharmaceuticals Inc. SONATA, being a non-benzodiazepine, competes in a niche where safety and efficacy are critical factors[2].

Market Projections

Growth Drivers

• Increasing Prevalence of Insomnia: The rising cases of insomnia and other sleep disorders are driving the demand for effective and safe treatments. This trend is expected to continue, favoring the growth of the sleep disorder treatment market[2].
• Preference for Non-Benzodiazepines: The preference for non-benzodiazepine hypnotics like SONATA due to their lower risk of dependency and side effects is another growth driver[2].

Regional Market Analysis

• North America: This region is expected to remain a significant market for sleep disorder treatments, including SONATA, due to high healthcare spending and a large patient population suffering from insomnia and other sleep disorders[2].

Challenges and Opportunities

Challenges

• Regulatory Scrutiny: Drugs like SONATA are under constant regulatory scrutiny due to their potential for abuse and side effects. This can impact market growth if stricter regulations are imposed[4].
• Competition from New Therapies: The sleep disorder treatment market is dynamic, with new therapies and drugs being developed. This competition can challenge the market share of established drugs like SONATA[2].

Opportunities

• Expanding Patient Base: The increasing awareness and diagnosis of sleep disorders offer opportunities for growth. As more patients seek treatment, the demand for effective drugs like SONATA is likely to increase[2].
• Innovative Marketing Strategies: Pharmaceutical companies can leverage innovative marketing strategies to raise awareness about the benefits of non-benzodiazepine hypnotics, potentially increasing market share[2].

Expert Insights and Statistics

Expert Views

"The sleep disorder treatment market is expected to see significant growth driven by the increasing prevalence of sleep disorders and the preference for safer and more effective treatments," said an industry expert. "Non-benzodiazepine hypnotics like SONATA are well-positioned to benefit from this trend."

Statistics

• Market Size: The global sleep disorder treatment market is projected to reach $30.102 billion by 2028, growing at a CAGR of 10.99% from 2021 to 2028[2].
• Segment Share: Non-benzodiazepine hypnotics, including SONATA, are expected to maintain a significant share of the market due to their safety profile and efficacy[2].

Key Takeaways

• Clinical Efficacy: SONATA has been shown to be effective in reducing sleep latency in clinical trials.
• Market Growth: The sleep disorder treatment market, including non-benzodiazepine hypnotics like SONATA, is expected to grow significantly.
• Competitive Landscape: The market is competitive, with major pharmaceutical companies vying for market share.
• Opportunities and Challenges: The market offers opportunities for growth due to an expanding patient base, but also faces challenges from regulatory scrutiny and competition from new therapies.

Frequently Asked Questions (FAQs)

1. What is SONATA used for?

SONATA, or zaleplon, is used for the short-term treatment of insomnia.

2. How effective is SONATA in clinical trials?

SONATA has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies.

3. What are the potential side effects of SONATA?

SONATA can cause complex sleep behaviors and is contraindicated in patients with hypersensitivity to zaleplon or its excipients.

4. How does the market for sleep disorder treatments look?

The global sleep disorder treatment market is expected to grow at a CAGR of 10.99% from 2021 to 2028, reaching $30.102 billion by 2028.

5. What are the growth drivers for the sleep disorder treatment market?

The increasing prevalence of insomnia and the preference for safer and more effective treatments like non-benzodiazepine hypnotics are key growth drivers.

Cited Sources

1. Sonata Therapeutics and the Champalimaud Foundation Announce Research Collaboration for SNT-3012 in Pancreatic and Colorectal Cancers - Biospace.
2. Sleep Disorder Treatment Market Size & Trends: Report, 2023-2028 - Knowledge Sourcing.
3. Sonnet BioTherapeutics, Inc. Enters into Licensing Agreement - Sonnet BioTherapeutics.
4. Sonata® (zaleplon) Capsules CIV DESCRIPTION - FDA.
5. Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032 - Fact.MR.

Last updated: 2024-12-31