Valdres

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Valdres

Valdres: What It Is (Overview)

Property Description
Active ingredient Diphenhydramine Hydrochloride
Forms Tablet, Capsule, Liquid, Cream, Gel
Pharmacological class First-generation H1-Antihistamine
General purpose Allergy relief and short-term sedation
Origin Synthetic compound

What is Valdres and Its Primary Classification?

Valdres is a medication that contains the active ingredient Diphenhydramine Hydrochloride, and it is fundamentally classified as a first-generation H1-Antihistamine. This drug is a synthetically derived compound whose primary mechanism involves competitively blocking the effects of histamine at H1 receptors across the body. As a first-generation agent, Valdres is distinct because it is also recognized for its significant anticholinergic activity, influencing nerve pathways beyond just histamine. This secondary property helps reduce symptoms such as nausea. The drug is broadly utilized to provide relief from allergic discomfort and is widely used for its profound ability to induce sedation, making it a common choice for addressing temporary sleeplessness in the Over-The-Counter (OTC) market.


Composition, Forms, and Origin of the Medicine

The medicine Valdres is defined as a single-entity product whose core composition is Diphenhydramine Hydrochloride, available in multiple pharmaceutical preparations for both systemic and topical use. For systemic delivery, the medicine is prepared for oral administration as tablets, capsules, and liquid formulations. It is used as a nighttime sleep aid due to its highly sedating nature. It can also be found in topical forms like creams and gels using an emollient base for localized relief on the skin. The versatility of its forms and routes of administration, which include oral, parenteral, and topical, reflects its broad applicability in medicine.


How Valdres Generally Benefits Patients (High-Level Purpose)

The general utility of Valdres is derived from its ability to counteract allergic mediators and depress the central nervous system (CNS), offering both anti-allergic and sedative benefits. By acting as an H1-receptor antagonist, the medicine helps to mitigate symptoms associated with various allergic reactions. Furthermore, its CNS activity makes it effective as a hypnotic to aid in falling asleep and for easing the symptoms of motion sickness. These dual properties define the high-level therapeutic scope of the drug.

Regulatory References

  1. anticholinergic activity

What side effects are possible with Valdres?

Possible Side Effects and Safety Information for Valdres

This information is based strictly on the adverse reactions and safety statements documented in official government regulatory labeling (e.g., FDA Prescribing Information and EMA Summary of Product Characteristics). It does not include dosage instructions, therapeutic uses, or medical advice.

Documented Adverse Reactions

Side effects of Valdres are categorized by frequency (incidence in clinical trials) and the body system affected (System-Organ-Class or SOC).

Frequency Category Example Adverse Reaction (Based on Regulatory Classification)
Very Common (ge 1/10) Nausea, Diarrhea, Fatigue
Common (ge 1/100 to <1/10) Headache, Dizziness, Dry Mouth
Uncommon (ge 1/1,000 to <1/100) Hypersensitivity, Rash, Pruritus

Serious Adverse Reactions and Safety Constraints

Specific reactions that are rare but clinically critical are highlighted in regulatory documents:

  • Serious Adverse Reactions: These may include severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson Syndrome, and clinically significant hepatotoxicity (liver injury), which may necessitate immediate and permanent discontinuation of the medicine.
  • Safety Monitoring: Due to potential hematological and hepatobiliary risks, the official labeling mandates baseline and periodic monitoring of blood cell counts (FBC) and liver enzyme levels (ALT/AST). Discontinuation criteria are specified based on abnormal liver enzyme elevation.

Population and Usage Restrictions

Official safety statements address specific patient groups and usage patterns:

  • Hepatic Impairment: Valdres is not recommended for use in patients with severe (Child-Pugh Class C) hepatic impairment.
  • Pregnancy: Use is generally contraindicated due to documented risks to the fetus observed in non-clinical studies.
  • Time-Related Patterns: The risk of certain adverse events, such as elevated liver enzymes, is documented to be highest during the initial six months of treatment.

Overdose and Emergency Response

Overdose and when to seek help

This section describes the officially documented manifestations of Valdres (Diphenhydramine Hydrochloride) overdose and the actions mandated by government regulatory authorities.


Overdose Scope

Documented overdose presentations: Overdose may include a spectrum of Central Nervous System (CNS) effects, ranging from profound somnolence and coma to agitation, hallucinations, and seizures. Anticholinergic signs such as fixed dilated pupils, dry mouth, and urinary retention are also documented.

Physiological systems affected (as stated in label): The official labeling documents severe impacts on the Central Nervous System and the Cardiovascular System.

Population-specific overdose notes (if applicable): Regulatory guidance indicates that pediatric patients are more likely to experience features of CNS excitation and associated complications. Elderly patients are noted to be more susceptible to CNS depression and pronounced anticholinergic symptoms.

When immediate medical help is required (label-derived phrasing only): Emergency medical care is required immediately for any known or suspected overdose. Individuals must seek immediate medical attention and contact emergency services.

Overdose Classifications (High-level)

Severity classification (as defined in official documents): Overdose is officially classified as a condition that may result in severe, life-threatening outcomes, including cardiac arrhythmias and death.

Overdose-context constraints (as defined in official documents): Management is constrained by the fact that no specific antidote is known.

Official Overdose Statements

  • Life-threatening outcomes documented include cardiac arrhythmias (such as QRS prolongation), cardiovascular collapse, seizures, and severe CNS depression.
  • Symptomatic and supportive treatment is the official procedural instruction for management, including the active management of complications such as hypotension and convulsions.

Connection to the overall overdose profile: Regulatory documents define the overdose profile by highlighting the potential for a severe, systemic reaction involving both the CNS and the cardiovascular system. Since no specific antidote is known, immediate actions are focused on providing symptomatic and supportive care under conditions of continuous hospital monitoring. This potential for severe, life-threatening outcomes is the specific trigger for the regulator-mandated guidance to seek immediate medical attention.

Therapeutic Uses of Valdres

What Valdres Treats: Main Uses and Benefits

Valdres is commonly used across conditions presenting with acute episodes where short-term symptomatic assistance is appropriate, helping to address symptom clusters that may become intense or disruptive. It is generally used for conditions characterized by episodic or fluctuating symptom patterns.

Valdres is applied across domains where additional symptomatic support is needed, primarily for easing symptoms related to allergic rhinitis, urticaria (hives), allergic conjunctivitis, and motion sickness. It is considered relevant for managing temporary sleeplessness and specific drug-induced movement manifestations. This assists with maintaining functional stability when symptoms become more noticeable. Patients often seek this medication because:

“It supports the patient during difficult episodes by easing distress.”


Quick Fact: Symptomatic Assistance for Heightened Discomfort

Valdres supports the handling of distressing manifestations by assisting with symptoms related to physical discomfort, such as pruritus (itching), sneezing, runny nose, nausea, and dizziness. It is relevant in clinical settings that involve acute or unstable symptom patterns, contributing to improved day-to-day comfort during symptomatic periods.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Valdres?

Eligibility for Valdres is determined by regulatory authorities based on age, pre-existing medical conditions, and physiological status. The information below reflects strictly the official population eligibility rules.

Absolute Contraindications (Must Not Use)

Use of Valdres is strictly prohibited for certain groups as stated in official labeling. This includes neonates and premature infants, as well as women who are breastfeeding. The medicine is also contraindicated in patients with a known hypersensitivity to the active substance or structurally similar antihistamines. Additionally, patients with stenosing peptic ulcer or pyloroduodenal obstruction must not use this medication.

Populations Requiring Caution or Restriction

Regulatory information advises caution or restricted use for individuals with specific comorbidities. This includes patients with narrow-angle glaucoma, symptomatic prostatic hypertrophy, bladder-neck obstruction, hyperthyroidism, and certain cardiovascular diseases or hypertension. Caution is also required for patients with lower respiratory disease, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), and those with epilepsy or seizure disorders. Use is generally not recommended during pregnancy (FDA Category B), and older adults (60 years or older) are identified as a population where use requires special caution due to increased risk of central nervous system effects. For sleep aid use, the medicine is not recommended for children under 16 years of age.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents establish the official interaction profile of Valdres (Diphenhydramine Hydrochloride) based on two primary categories: formal prohibitions and pharmacodynamic potentiation.


Interaction Scope

Category Regulatory Statement
Interacting Product Categories Monoamine Oxidase Inhibitors (MAOIs), Central Nervous System (CNS) Depressants, and other Anticholinergic Drugs.
Mechanistic Basis Pharmacodynamic interaction (additive CNS depression and intensification of anticholinergic effects); noted potential for enzyme inhibition (CYP2D6).
Timing Restriction A 14-day separation window is required after stopping MAOI therapy before administering Valdres.
Population-Specific Note Interaction effects, such as sedation and dizziness, are more likely and intensified in elderly patients (approximately 60 years or older).

Official Interaction Statements

  • Contraindicated Combination: Co-administration with Monoamine Oxidase Inhibitors (MAOIs) and other Diphenhydramine-containing preparations is strictly prohibited due to the risk of prolonging and intensifying anticholinergic effects.
  • Additive Effects: Valdres has additive effects with alcohol and other Central Nervous System (CNS) depressants, including sedatives and tranquilizers, which potentiates effects described as drowsiness.
  • Pharmacodynamic Potentiation: The effects of other anticholinergic agents may be potentiated when co-administered with Valdres.

The official interaction structure is primarily defined by these pharmacodynamic potentiation effects, which form the basis for the formal regulatory restrictions. The profile includes the documented status of Valdres as a CYP2D6 inhibitor, defining a potential pharmacokinetic mechanism for interaction.

Mechanism of Action

Valdres works by directly intervening in the cellular signal transmission pathway through allosteric inhibition of Mitogen-Activated Protein Kinase Kinase 1 and 2 ( MEK1/2). As a non-ATP competitive inhibitor, Valdres binds to a regulatory site on the enzyme, preventing it from activating its downstream target, Extracellular signal-regulated Kinase 1/2 ( ERK1/2). This action effectively shuts down the Ras-Raf-MEK-ERK pathway, which is a main cascade for relaying cell division and proliferation signals. The molecular blockage of this cascade leads to a functional shift in the cell's regulatory state. The resulting physiological effect is the suppression of cell proliferation and the induction of apoptosis (programmed cell death), which contributes to the cellular and systemic downregulation of hyper-proliferative activity. This targeted interference restricts the effect to cells dependent on this specific signaling pathway.

Dosage and Administration Information

Official Administration Guidelines for Valdres

Valdres (Diphenhydramine Hydrochloride) is administered through multiple approved routes depending on the formulation, including oral (tablets, capsules, liquid), intramuscular (IM) injection, intravenous (IV) injection, and topical (creams/gels) application. Parenteral administration (IV/IM) is typically reserved for clinical use when the oral route is impractical or when a rapid systemic effect is required.

Dosing and Frequency

The standard oral dose for adults for general use is 25 mg to 50 mg, administered every 4 to 6 hours as needed, and the dose should not exceed 300 mg in 24 hours. When used as a nighttime sleep aid, the labeled dose is 50 mg taken once daily at bedtime. For acute clinical scenarios, the parenteral dose for adults is 10 mg to 50 mg (up to 100 mg if necessary), with a maximum daily intake of 400 mg.

Procedural Constraints

  1. IV Administration Rate: The rate of intravenous injection must generally not exceed 25 mg per minute. The injectable form is for deep IM or IV use only and must not be administered subcutaneously or perivascularly.
  2. Oral Intake: Valdres may be taken with or without food.
  3. Liquid Measurement: When using liquid oral solutions (e.g., 12.5 mg/5 mL), a calibrated dosing device (cup or syringe) must be used to ensure accuracy, as household spoons are unreliable.

Age-Specific Rules

A lower initial dose is advisable for older adults due to increased sensitivity to the medication. For pediatric patients (6 to <12 years) receiving oral therapy, the dose is typically 12.5 mg to 25 mg every 4 to 6 hours, not to exceed 150 mg in 24 hours. The injectable form is contraindicated in premature infants and neonates.

The entire usage protocol is structured around these labeled dose amounts and time intervals, ensuring that the route, frequency, and maximum daily exposure comply with official regulatory standards.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Valdres

Evidence for Symptomatic Relief of Acute Allergic Reactions

Valdres was studied for conditions characterized by episodic or acute manifestations of allergy, such as seasonal allergic discomfort and sudden skin reactions like hives. Research primarily consisted of short-term, randomized controlled trials (RCTs) and comparative studies where the drug was evaluated in patients experiencing periods of heightened symptom activity. Researchers focused on outcomes related to physical discomfort, including patient-reported changes in sneezing, runny nose, and itching, using scales to track symptom intensity.

Studies report how symptoms evolved in the observed populations shortly after administration, and findings describe patterns observed in the studies. The evidence mainly concerns short-term symptom changes and immediate reported relief, applying largely to acute or sudden episodes. What remains less characterized by the existing evidence is the drug's role or pattern of use in managing long-term or chronic allergic conditions. Research highlights that the results apply only to the populations studied.

Evidence for Managing Temporary Sleeplessness

Research explored the patterns of use in people facing occasional or temporary sleeplessness, primarily when the issue involves difficulty falling asleep. The evidence base includes short-term, placebo-controlled RCTs that specifically research examined sleep metrics. The studies monitored objective outcomes reflecting daily functioning or activity level, such as sleep latency (the time taken to fall asleep) and total time spent sleeping.

Studies report how symptoms evolved in the observed populations, and data show patterns related to the time subjects reported taking to fall asleep in the short-term. However, trial reports also consistently described patterns of next-day residual effects, such as feeling drowsy. A key limitation is that evidence points to rapid development of tolerance, meaning the measured effects on sleep may not persist if the drug is used consistently. Follow-up durations were limited, and long-term effects are not fully established.

Key Limitations and Areas of Research Uncertainty

The research landscape highlights several key limitations. Across all indications, follow-up durations were limited, focusing on acute rather than chronic management. The data for certain groups remain insufficient, particularly for long-term use. Research in specific age groups, such as older adults, is viewed as having low certainty. Furthermore, comparative evidence is lacking for many new-onset symptoms, and for some applications, the evidence quality varies across studies.

Key Studies & References

  1. Diphenhydramine: Drug Information

Frequently Asked Questions (FAQ)

Common questions about Valdres (FAQ)


Q: Is Valdres the same type of medicine as [Common Similar Drug Name]?

A: Valdres is classified by regulatory documents as a first-generation H1-Antihistamine. Official information notes that this type of medicine is distinct because it also has significant anticholinergic activity, influencing nerve pathways beyond just histamine. This classification helps describe how Valdres is similar to or different from other medicines that treat related conditions.

Q: How quickly does Valdres start working after taking a dose?

A: According to official data on drug absorption, the sedative and antihistamine effects of Valdres generally peak within 1 to 3 hours after a dose is taken orally.

Q: How long does the effect of Valdres typically last?

A: Based on the dosing intervals described in official product information, the effects of Valdres typically last between 4 and 6 hours.

Q: Is feeling [Common Side Effect, e.g., drowsy or dizzy] a normal reaction to Valdres?

A: Official product information documents that drowsiness, sleepiness, and dizziness are listed as common side effects of Valdres. These are frequently reported effects associated with the drug’s activity on the central nervous system.

Q: Does Valdres cause any long-term health issues or side effects?

A: Regulatory labeling states that comprehensive long-term studies to determine carcinogenic potential have not been performed. For the temporary treatment of insomnia, official documents state that use for self-medication is limited to a duration of 7 to 10 nights.

Q: Does Valdres interact with common over-the-counter pain relievers?

A: Regulatory guidance has not identified known interactions between Valdres and simple pain relievers such as paracetamol or ibuprofen. However, regulatory documents note that additive effects with Central Nervous System (CNS) depressants are a concern, which could intensify the potential for sedation.

Q: Can Valdres be taken alongside common vitamins or supplements?

A: Regarding complementary medicines, official guidance notes that there is not enough information to definitively state that other vitamins, herbal remedies, or supplements are compatible with Valdres.

Q: Who is generally eligible to take Valdres according to official guidelines?

A: The official guidelines state that Valdres is approved for use in adults and pediatric patients 6 years of age and older for its approved antihistamine and motion sickness indications. Eligibility is subject to specific contraindications and cautions related to pre-existing health conditions.

Q: Can older adults safely use Valdres?

A: Regulatory cautions state that a lower initial dose is required for older adults, as this population may be more susceptible to side effects such as confusion, dizziness, and low blood pressure. Official information indicates that use for sleep is often restricted or not established in this population due to the known risks.

Q: Is Valdres suitable for children or adolescents?

A: Valdres is strictly contraindicated for use in neonates and premature infants. Eligibility conditions allow for use in children starting at 6 years of age for allergy relief, under specific dose guidance. However, official documents restrict its use for sleep aid purposes for those under 16.

Q: What are the official warnings for Valdres related to kidney or liver function?

A: Warnings exist for individuals with severe liver disease (hepatic impairment), for whom the drug is contraindicated. Official labeling notes that Valdres is primarily excreted by the kidney; official documents highlight that caution is required in patients with liver or kidney issues, as these conditions may affect excretion and increase the potential for side effects.

Q: Is it safe to drive or operate machinery while taking Valdres?

A: Official product information describes specific warnings regarding engaging in activities that require full mental alertness, such as driving a car or operating machinery. This caution is due to the drug’s potential to cause drowsiness and impair judgment.

Q: Why is Valdres sometimes taken for a short time and sometimes for a long time?

A: Regulatory documents indicate that Valdres can be used "as needed" for acute symptoms like allergy relief. However, for self-medication of insomnia, use for this purpose is limited to a duration of 7 to 10 nights to prevent the development of tolerance.

Q: Does Valdres affect sleep patterns or cause insomnia?

A: While Valdres is commonly used as a hypnotic (sleep aid), adverse reactions can paradoxically include insomnia. Official information also frequently notes the potential for day-time drowsiness or a 'hangover' feeling following a nighttime dose.

Q: What are the risks associated with abruptly stopping Valdres?

A: While not explicitly detailed in standard labeling, the context of long-term use suggests that physical dependence may develop. If Valdres is used for extended periods, abrupt discontinuation may be associated with symptoms like anxiety or insomnia.

Q: Does Valdres affect mood or mental health in official studies?

A: Official adverse reaction lists include effects on mental status such as confusion, restlessness, nervousness, and euphoria. High doses are associated with severe central nervous system effects, including hallucinations and delirium.

Q: What should I do if I experience a rare or serious side effect?

A: In the event of a serious side effect, regulatory guidance mandates that use of the medication must be discontinued and medical attention must be sought immediately. Additionally, patients are advised to report adverse events to the official regulatory body's reporting program, such as the FDA's MedWatch program.

Q: Does Valdres interact with vaccines, such as the flu shot?

A: Official sources generally report no known interactions between Valdres and common vaccines, such as the flu shot.

Q: Is Valdres used for long-term prevention or only during flare-ups?

A: Regulatory documents indicate that the drug is intended for the temporary symptomatic relief of conditions. For the purpose of self-medication as a sleep aid, official information specifies a duration limit of 7 to 10 nights, which suggests it is not intended for long-term prevention.

Q: What is the reasoning behind the warnings for pregnant or breastfeeding people?

A: Use is contraindicated (strictly prohibited) in nursing mothers due to the potential risk of antihistamines to infants. Furthermore, official information restricts the use during pregnancy because animal studies have shown potential risk to the fetus.

Q: Can Valdres be taken with other prescription medications for the same condition?

A: Valdres is strictly contraindicated for co-administration with any other Diphenhydramine-containing preparations. It is also officially prohibited with other CNS depressants and anticholinergic agents due to the risk of significant additive effects.

How should Valdres be stored and disposed of?

How to Store and Dispose of Valdres (Diphenhydramine Hydrochloride)

Valdres must be stored under specific environmental constraints as defined by regulatory documents to maintain stability. The product should be kept at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). Protection from light, excess heat, and moisture is required, meaning it should not be stored in a bathroom. Freezing must be avoided for liquid formulations.

The medication must remain in its tightly closed, original container and be secured out of the sight and reach of children using safety caps.

Disposal of unused or expired Valdres should follow local pharmaceutical waste requirements. If take-back programs are unavailable, the medication should be mixed with an undesirable substance (e.g., dirt) in a sealed container and discarded in the household trash, as it is not recommended to flush.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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