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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR AMBIEN CR


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All Clinical Trials for Ambien Cr

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00042146 ↗ Behavioral and Pharmacological Treatment for Insomnia Completed National Institute of Mental Health (NIMH) Phase 4 2001-12-01 This study will evaluate the long- and short-term effects of cognitive-behavior therapy (CBT), alone and in combination with zolpidem (AmbienĀ®), for chronic insomnia.
NCT00042146 ↗ Behavioral and Pharmacological Treatment for Insomnia Completed Laval University Phase 4 2001-12-01 This study will evaluate the long- and short-term effects of cognitive-behavior therapy (CBT), alone and in combination with zolpidem (AmbienĀ®), for chronic insomnia.
NCT00044629 ↗ Combined Behavioral/Pharmacological Therapy for Insomnia Completed National Institute of Mental Health (NIMH) Phase 2 2001-09-01 This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
NCT00044629 ↗ Combined Behavioral/Pharmacological Therapy for Insomnia Completed Duke University Phase 2 2001-09-01 This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ambien Cr

Condition Name

Condition Name for Ambien Cr
Intervention Trials
Healthy 9
Insomnia 8
Sleep 4
Sleep Initiation and Maintenance Disorders 4
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Condition MeSH

Condition MeSH for Ambien Cr
Intervention Trials
Sleep Initiation and Maintenance Disorders 20
Depression 5
Sleep Wake Disorders 3
Parasomnias 3
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Clinical Trial Locations for Ambien Cr

Trials by Country

Trials by Country for Ambien Cr
Location Trials
United States 73
Canada 4
India 2
Germany 1
Argentina 1
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Trials by US State

Trials by US State for Ambien Cr
Location Trials
California 8
Pennsylvania 8
New York 6
Massachusetts 5
Ohio 4
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Clinical Trial Progress for Ambien Cr

Clinical Trial Phase

Clinical Trial Phase for Ambien Cr
Clinical Trial Phase Trials
Phase 4 18
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ambien Cr
Clinical Trial Phase Trials
Completed 40
Recruiting 2
Unknown status 2
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Clinical Trial Sponsors for Ambien Cr

Sponsor Name

Sponsor Name for Ambien Cr
Sponsor Trials
Sanofi 6
National Institute of Mental Health (NIMH) 6
National Institutes of Health (NIH) 4
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Sponsor Type

Sponsor Type for Ambien Cr
Sponsor Trials
Other 37
Industry 25
U.S. Fed 14
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Clinical Trials and Efficacy of AMBIEN CR

Overview of AMBIEN CR

AMBIEN CR, or zolpidem tartrate extended-release tablets, is a prescription sleep medicine approved by the FDA for the treatment of insomnia characterized by difficulties with sleep onset and maintenance[4].

Long-Term Efficacy and Safety

A significant multicenter, double-blind, placebo-controlled study involving 1,018 adult volunteers over 25 weeks demonstrated the long-term efficacy and safety of AMBIEN CR. This study showed that AMBIEN CR was well-tolerated and effective in improving sleep onset and maintenance for up to six months in patients with chronic primary insomnia. The drug significantly improved total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset (WASO), sleep quality, and the number of awakenings compared to placebo. Notably, there was no rebound insomnia following discontinuation[1].

Patient Global Impression and Clinical Global Impression

The study used Patient Global Impression (PGI) and Clinical Global Impression (CGI) scales to assess efficacy. At weeks 12 and 24, a significant percentage of patients in the AMBIEN CR group reported improvement in their sleep, with 89.8% and 92.3% of patients, respectively, compared to 51.4% and 59.7% in the placebo group. Similarly, the CGI scale showed that a higher percentage of patients in the AMBIEN CR group were rated as "much or very much improved" by clinicians at each 4-week interval[1].

Co-Morbid Insomnia and Major Depressive Disorder (MDD)

Another study presented at the SLEEP 2008 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS) showed that AMBIEN CR significantly improved sleep onset, sleep maintenance, and total sleep time in patients with co-morbid insomnia and MDD who were also administered a Selective Serotonin Reuptake Inhibitor (SSRI) for depression. This study highlighted that AMBIEN CR can be a viable treatment option for patients with insomnia and MDD, improving not only sleep quality but also next-day functioning measures[3].

Adverse Reactions and Safety Profile

Clinical trials have identified several adverse reactions associated with AMBIEN CR. Common adverse events include headache, nausea, and anxiety. The incidence of these events was generally higher in the AMBIEN CR group compared to the placebo group, although most were mild to moderate in severity. Notably, there were reports of rare but serious side effects such as hallucinations and disorientation[4].

Market Analysis

Current Market Status

As of 2024, AMBIEN CR, along with its immediate-release counterpart AMBIEN, has been acquired by Cosette Pharmaceuticals from Sanofi US. This acquisition ensures the continued supply of these medications to patients in the US market. The annual sales for AMBIEN and AMBIEN CR in the US were $39 million for the 12 months ending April 2024[2].

Historical Market Challenges

In the past, AMBIEN and AMBIEN CR faced market challenges due to negative perceptions and anecdotal reports of sleepwalking (somnambulism). These reports led to a decline in new prescriptions, with a 13.7% drop in AMBIEN prescriptions and a 15.3% drop in AMBIEN CR prescriptions in a three-week period in 2006. To address these concerns, Sanofi-Aventis increased marketing efforts to clarify the safety information and reassure patients and healthcare providers[5].

Market Projections

Future Outlook

Given the recent acquisition by Cosette Pharmaceuticals, the market outlook for AMBIEN CR is expected to remain stable. Cosette's expertise in integrating and managing critical drugs from global pharmaceutical companies should ensure uninterrupted access to AMBIEN CR for patients. The company's commitment to maintaining high-quality products and its strategic approach to product transitions are likely to support continued market presence and potentially even growth.

Competitive Landscape

The sleep aid market is competitive, with other drugs like Lunesta (eszopiclone) and Rozerem (ramelteon) available. However, AMBIEN CR's unique controlled-release formulation and its established efficacy and safety profile position it as a strong contender. The ability of AMBIEN CR to address both sleep onset and maintenance issues makes it a preferred option for many patients and healthcare providers.

Key Takeaways

  • Efficacy: AMBIEN CR is effective in improving sleep onset and maintenance for up to six months in patients with chronic primary insomnia.
  • Safety: The drug is well-tolerated with a manageable safety profile, although it includes rare but serious side effects like sleepwalking.
  • Market Status: The drug has been acquired by Cosette Pharmaceuticals, ensuring continued supply and potentially stable market presence.
  • Competitive Landscape: AMBIEN CR remains competitive in the sleep aid market due to its unique formulation and established efficacy.

FAQs

Q: What is AMBIEN CR used for?

A: AMBIEN CR is used for the treatment of insomnia characterized by difficulties with sleep onset and maintenance.

Q: How long can AMBIEN CR be used safely?

A: Clinical trials have shown that AMBIEN CR can be safely and effectively used for up to six months in patients with chronic primary insomnia.

Q: What are the common side effects of AMBIEN CR?

A: Common side effects include headache, nausea, and anxiety. Rare but serious side effects can include hallucinations and disorientation.

Q: Who currently manufactures AMBIEN CR in the US?

A: As of 2024, AMBIEN CR is manufactured and distributed by Cosette Pharmaceuticals in the US.

Q: How does AMBIEN CR compare to other sleep aids in the market?

A: AMBIEN CR's controlled-release formulation makes it effective for both sleep onset and maintenance, positioning it as a strong contender in the sleep aid market.

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