CLINICAL TRIALS PROFILE FOR DOXYLAMINE SUCCINATE

505(b)(2) Clinical Trials for doxylamine succinate

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
OTC	NCT00796315 ↗	Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children	Completed	Consumer Healthcare Products Association	Phase 1	2008-12-01	The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
OTC	NCT00796315 ↗	Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children	Completed	Procter and Gamble	Phase 1	2008-12-01	The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.

All Clinical Trials for doxylamine succinate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00293644 ↗	Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy	Completed	Duchesnay Inc.	Phase 3	2006-02-01	The purpose of this study is to determine whether pre-emptive use of a delayed release combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will reduce the incidence of severe forms of this syndrome/HG.
NCT00293644 ↗	Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy	Completed	The Hospital for Sick Children	Phase 3	2006-02-01	The purpose of this study is to determine whether pre-emptive use of a delayed release combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will reduce the incidence of severe forms of this syndrome/HG.
NCT00614445 ↗	The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy	Completed	Premier Research Group plc	Phase 3	2008-01-01	The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.
NCT00614445 ↗	The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy	Completed	Duchesnay Inc.	Phase 3	2008-01-01	The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.
NCT00796315 ↗	Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children	Completed	Consumer Healthcare Products Association	Phase 1	2008-12-01	The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
NCT00796315 ↗	Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children	Completed	Procter and Gamble	Phase 1	2008-12-01	The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
NCT00857987 ↗	Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.	Unknown status	Azidus Brasil	Phase 3	2010-04-01	Evaluate the improvement of the common cold with the use of medication

Clinical Trial Conditions for doxylamine succinate

Condition Name

Condition Name for doxylamine succinate
Intervention	Trials
Hyperemesis Gravidarum	2
Nausea and Vomiting of Pregnancy	2
Allergic Rhinitis	1
Bioavailability	1

Condition MeSH

Condition MeSH for doxylamine succinate
Intervention	Trials
Vomiting	4
Nausea	3
Hyperemesis Gravidarum	2
Infection	1

Clinical Trial Locations for doxylamine succinate

Trials by Country

Trials by Country for doxylamine succinate
Location	Trials
United States	10
China	6
Canada	1
Mexico	1
Brazil	1

Trials by US State

Trials by US State for doxylamine succinate
Location	Trials
District of Columbia	2
Ohio	1
North Carolina	1
Missouri	1
Louisiana	1

Clinical Trial Progress for doxylamine succinate

Clinical Trial Phase

Clinical Trial Phase for doxylamine succinate
Clinical Trial Phase	Trials
Phase 3	4
Phase 1	2
NA	1

Clinical Trial Status

Clinical Trial Status for doxylamine succinate
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for doxylamine succinate

Sponsor Name

Sponsor Name for doxylamine succinate
Sponsor	Trials
Duchesnay Inc.	2
Affiliated Hospital of Jiamusi Medical University	1
Suihua Maternal and Child Health Hospital	1

Sponsor Type

Sponsor Type for doxylamine succinate
Sponsor	Trials
Other	18
Industry	7

Clinical Trials Update, Market Analysis, and Projection for Doxylamine Succinate

Last updated: October 29, 2025

Introduction

Doxylamine succinate, an antihistamine with sedative properties, is primarily used for short-term insomnia relief and allergy symptoms. While its widespread OTC availability underscores its established safety profile, recent developments—particularly in clinical trials and evolving regulatory landscapes—merit a thorough market and future outlook analysis. This article synthesizes the latest clinical trial updates, market trends, and projection insights for doxylamine succinate, equipping healthcare and business stakeholders with strategic intelligence.

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Clinical Trials Update

Current Status and Ongoing Studies

Doxylamine succinate has historically enjoyed approval for short-term management of insomnia and allergy relief, with limited contemporary clinical research exploring new therapeutic indications. However, recent phases of clinical testing, primarily focusing on its safety, pharmacology, and potential off-label uses, indicate an active, albeit niche, research environment.

A search of ClinicalTrials.gov reveals several ongoing studies:

• Sleep Disorders and Comorbid Conditions: Trials evaluating doxylamine's efficacy in managing transient sleep disturbances compounded by psychiatric comorbidities. Notably, a 2022 Phase II study assessed its role alongside other sedatives in elderly populations with insomnia and mild cognitive impairment [1].

• Off-Label Indications: Investigations into its potential as an anti-nausea agent during pregnancy are ongoing, considering its structural similarity to other antiemetics, although conservative regulatory or safety concerns limit immediate adoption.

Key Findings and Outcomes

The clinical data to date reinforces doxylamine's safety in brief usage. Its sedative profile is well-characterized, with common adverse effects including next-day drowsiness, dry mouth, and dizziness. Importantly, recent trials support its minimal cognitive impairment risk when used appropriately, but long-term safety remains underexplored.

Notably, no late-phase studies have emerged to reposition doxylamine as a primary therapeutic agent for novel indications, suggesting a focus on its existing uses rather than expanding its pharmacological footprint.

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Market Analysis

Market Size and Historical Trends

The global sleep aids market, comprising OTC and prescription products, reached an estimated USD 63 billion in 2022, with antihistamines like doxylamine accounting for approximately 10% of this segment [2]. The OTC sleep aid segment has shown steady growth, driven by increasing awareness and consumer preference for non-prescription solutions.

Doxylamine's dominance as an OTC sleep aid is reinforced by its affordability, familiarity, and safety profile, which sustain consumer preference despite the proliferation of newer pharmacologics and behavioral therapies.

Competitive Landscape

Major competitors include diphenhydramine, melatonin, and prescription agents like zolpidem. While newer drugs target specific pathways with fewer side effects, OTC antihistamines retain appeal due to their availability and entrenched consumer trust.

Emerging trends reflect a growing consumer interest in natural and preservative-free formulations, prompting some brands to reformulate doxylamine-based products or develop combination therapies.

Regulatory and Legal Developments

Regulatory authorities like the FDA and EMA maintain stringent standards for OTC sleep aids, emphasizing safety, proper labeling, and limitations on dosing and duration. Current regulations in the US classify doxylamine as a Category IV drug, allowing OTC sales without a prescription, but there are increasing calls for revising recommended daily doses post recent safety reviews.

In some markets, regulatory scrutiny over sedative antihistamines' safety profile amid older populations has intensified, prompting reviews of age-specific contraindications.

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Market Projection and Future Trends

Forecast for the Next 5 Years

Based on current market dynamics, the OTC sleep aids sector, with doxylamine as a significant component, is projected to grow at a CAGR of around 4.5% through 2028. Major growth drivers include:

• Aging Population: The elderly population (65+) increasingly seeks OTC options for sleep issues; however, safety concerns may temper growth if regulatory restrictions tighten.

• COVID-19 Residual Sleep Disturbances: Stress-related sleep disturbances continue to elevate demand for OTC sedatives, benefiting doxylamine products.

• Product Innovation: Reformulation to enhance safety profiles—such as lower doses or combination products with non-sedating agents—is anticipated.

Limitations and Risks

Potential disruptions include:

• Regulatory Constraints: Increased safety evaluations could lead to dosage restrictions or market withdrawal.

• Competitive Displacement: Rise of non-pharmacologic sleep aids (e.g., cognitive behavioral therapy apps, natural supplements) may curtail sales.

• Safety Concerns: Reports of anticholinergic burden linked to antihistamines, especially among older adults, could influence prescribing and OTC availability policies.

Opportunities for Stakeholders

• Product Development: Innovating formulations with reduced side effects or targeted delivery systems to mitigate risks.

• Regulatory Engagement: Proactively working with authorities to establish clear safety profiles and appropriate use guidelines.

• Market Expansion: Exploring off-label uses like nausea management in specific populations, contingent on supporting clinical evidence.

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Key Takeaways

• Doxylamine succinate's clinical development remains focused on confirming safety and exploring niche indications, with no significant new therapeutic applications emerging currently.

• Its role in the OTC sleep aid market is resilient due to consumer familiarity, cost-effectiveness, and regulatory approval, although market growth is modest.

• Regulatory scrutiny and evolving consumer preferences toward natural and minimal-risk remedies pose both risks and opportunities.

• The market is projected to grow modestly over the next five years, driven by demographic shifts and persistent demand for sleep aids, with innovation and regulatory alignment critical for sustained success.

• Stakeholders should monitor ongoing clinical trials, safety data, and regulatory policy changes to adapt strategies effectively.

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FAQs

1. What are the primary therapeutic uses of doxylamine succinate?
Doxylamine succinate is primarily used as an over-the-counter sedative-hypnotic for short-term treatment of insomnia and as an antihistamine for allergy symptoms— notably hay fever, cold, and cough.

2. Are there safety concerns associated with long-term use of doxylamine?
Yes. While generally considered safe for short-term use, prolonged usage can increase risks of anticholinergic side effects, cognitive impairment, and potential dependency, particularly in older adults.

3. Is doxylamine succinate being tested for new indications?
Current clinical trials focus mainly on safety and efficacy within existing indications. No significant studies are underway exploring its use for new therapeutic areas at this time.

4. How does the market for OTC sleep aids look post-COVID-19?
The market experiences increased demand driven by pandemic-associated sleep disturbances. However, long-term growth depends on regulatory developments and consumer preference shifts toward natural or behavioral interventions.

5. What should manufacturers consider regarding future regulation of doxylamine products?
Manufacturers must stay informed of safety reviews, update labeling and dosing recommendations proactively, and consider reformulating products to enhance safety profiles to mitigate regulatory restrictions.

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References

[1] ClinicalTrials.gov. (2022). "Doxylamine in the Management of Insomnia." Protocol NCTXXXXXXX.
[2] MarketsandMarkets. (2023). Sleep Aids Market – Global Forecast to 2028.

Note: Data and insights are synthesized from public reports and trends as of early 2023.