CLINICAL TRIALS PROFILE FOR SILENOR

All Clinical Trials for SILENOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03758079 ↗	Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus	Completed	University of Balamand	Phase 4	2018-06-01	This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Patients were divided into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were treated reversley. Pruritus severity and its effect on quality of life will be assessed by using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2 and week4
NCT02353299 ↗	Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers	Completed	Henry Ford Hospital	Phase 4	2015-01-01	This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects
NCT02353299 ↗	Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers	Completed	Currax Pharmaceuticals	Phase 4	2015-01-01	This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects
NCT02353299 ↗	Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers	Completed	Pernix Theraputics LLC	Phase 4	2015-01-01	This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects

Clinical Trial Conditions for SILENOR

Condition Name

Condition Name for SILENOR
Intervention	Trials
Healthy	1
Uremic Pruritus	1

Condition MeSH

Condition MeSH for SILENOR
Intervention	Trials
Pruritus	1
Ataxia	1

Clinical Trial Locations for SILENOR

Trials by Country

+

−

Trials by Country for SILENOR
Location	Trials
Lebanon	1
United States	1

Trials by US State

+

−

Trials by US State for SILENOR
Location	Trials
Michigan	1

Clinical Trial Progress for SILENOR

Clinical Trial Phase

Clinical Trial Phase for SILENOR
Clinical Trial Phase	Trials
Phase 4	2

Clinical Trial Status

Clinical Trial Status for SILENOR
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for SILENOR

Sponsor Name

Sponsor Name for SILENOR
Sponsor	Trials
Henry Ford Hospital	1
Currax Pharmaceuticals	1
Pernix Theraputics LLC	1

Sponsor Type

Sponsor Type for SILENOR
Sponsor	Trials
Other	2
Industry	2

Silenor (Doxepin) for Insomnia: Clinical Trials, Market Analysis, and Projections

Introduction

Silenor, a low-dose formulation of the tricyclic antidepressant doxepin, is specifically indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. Here, we delve into the clinical trials that led to its approval, its market analysis, and future projections.

Clinical Trials Overview

Phase III Clinical Trials

The efficacy and safety of Silenor were established through several phase III clinical trials. One key trial involved 240 elderly subjects with chronic primary insomnia, evaluating the 1mg and 3mg doses of Silenor over a 12-week period. The results showed that both doses achieved statistical significance for objective measures of sleep maintenance, including the primary endpoint of Wake After Sleep Onset (WASO)[1].

Another phase III trial enrolled 565 subjects in a sleep laboratory setting, using a phase-advance, first night assessment model of induced transient insomnia. This study demonstrated that Silenor 3mg and 6mg doses significantly improved both objective and subjective measures of sleep onset and maintenance, meeting the primary endpoint of Latency to Persistent Sleep (LPS)[1].

Key Findings

• Sleep Maintenance: Silenor significantly improved sleep maintenance in both chronic and transient insomnia populations.
• Adverse Effects: The adverse events reported were comparable to placebo, with no significant next-day residual effects on cognitive performance or memory impairment[1][3].
• Dosing: The recommended doses are 3mg and 6mg once daily, with the 3mg dose showing consistent results without significant long-term adverse effects[5].

Market Analysis

Approval and Marketing

Silenor was approved by the US FDA in March 2010 for the treatment of insomnia characterized by difficulty with sleep maintenance. In the US, Somaxon Pharmaceuticals initially marketed Silenor, but in June 2011, the commercial rights were sold to Paladin Labs for $129 million. Paladin holds the marketing rights in Canada, Africa, and South America[1].

Market Dynamics

The insomnia market is significant, with approximately 70 million adults in the US affected by insomnia. According to the National Sleep Foundation’s 2012 Sleep in America survey, a substantial portion of the population experiences insomnia symptoms, making the market for insomnia treatments lucrative[1].

Competitive Landscape

Silenor competes with other insomnia treatments such as Intermezzo (zolpidem), another prescription therapy for insomnia. However, Silenor's unique low-dose formulation and lack of next-day residual effects position it favorably in the market[1].

Market Projections

Current Market Status

Given the prevalence of insomnia and the specific indication of Silenor for sleep maintenance, the drug has a solid market presence. The sale of commercial rights to Paladin Labs has expanded its reach beyond the US market[1].

Future Projections

While specific financial projections for Silenor are not readily available, the overall market for sleep disorders is expected to grow. The increasing awareness and diagnosis of sleep disorders, coupled with an aging population, suggest a continued demand for effective treatments like Silenor.

Patent Expiration

The patents for Silenor are set to expire in the 2024-2025 period, which could lead to the entry of generic versions and potentially impact the market dynamics. However, this also presents opportunities for brand extensions and new formulations[2].

Key Takeaways

• Clinical Efficacy: Silenor has demonstrated significant improvements in sleep maintenance with minimal adverse effects.
• Market Presence: It is marketed in several regions, including the US, Canada, Africa, and South America.
• Competitive Advantage: Its low-dose formulation and lack of next-day residual effects make it a preferred option for some patients.
• Future Outlook: The expiration of patents may lead to generic competition but also opens avenues for new product developments.

FAQs

What is Silenor used for?

Silenor is used for the treatment of insomnia characterized by difficulty with sleep maintenance.

How effective is Silenor in clinical trials?

Silenor has shown significant improvements in sleep maintenance in both chronic and transient insomnia populations, with minimal adverse effects.

What are the recommended doses of Silenor?

The recommended doses are 3mg and 6mg once daily, with the 3mg dose being particularly effective without significant long-term adverse effects.

Who markets Silenor?

Silenor is marketed by Paladin Labs in Canada, Africa, and South America, following the sale of commercial rights from Somaxon Pharmaceuticals.

When do the patents for Silenor expire?

The patents for Silenor are set to expire in the 2024-2025 period.

Sources

1. Clinical Trials Arena: Silenor (doxepin) for the Treatment of Insomnia - Clinical Trials Arena
2. DrugPatentWatch: When will the patents on SILENOR expire, and ... - DrugPatentWatch
3. American Academy of Family Physicians: Doxepin (Silenor) for Insomnia - AAFP
4. FDA Label: SILENOR® (doxepin) tablets, for oral use - accessdata.fda.gov

"Insomnia is a sleep disorder that is characterised by a regular difficulty in falling asleep or staying asleep, or sleep of poor quality. It may lead to serious psychological and physiological health problems."[1]