Daonil

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Glibenclamide

Method of action: Antithrombotic, Drugs Used In Diabets, Hypocholesterolemic, Hypoglycemic, Lipid-Lowering

Treatment option: Insulin Dependent Diabetes, Diabetes Mellitus

Medically reviewed

Laura Arias

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 Daonil

Property	Description
Active ingredient	Glibenclamide (Glyburide)
Form	Oral tablet (uncoated, scored)
Pharmacological class	Antidiabetic agent / Sulfonylurea
General purpose	Lowering high blood sugar (glucose)
Origin	Synthetic, second-generation derivative

What Type of Medicine is Daonil?

Daonil is a well-established trade name for the active ingredient Glibenclamide, which is classified as an antidiabetic agent used to manage elevated blood sugar levels in adults. This medicine is a synthetic, prescription-only medicine that belongs to the sulfonylurea class of drugs, designated specifically as a second-generation sulfonylurea derivative.

The essential nature of Glibenclamide is that of an oral antidiabetic, intended for daily use, which is a key distinguishing factor from injectable therapies like Insulin. As an insulin secretagogue, its core therapeutic role is to actively promote the body's natural release of insulin from the pancreatic cells to regulate blood glucose concentrations. Glibenclamide is clinically recognized for its effectiveness in stimulating insulin secretion from existing beta cells.

Composition, Form, and General Purpose

The medicine is supplied as a single-ingredient product, confirming that Glibenclamide is the exclusive component providing the therapeutic effect. It is typically formulated as an oral tablet, which may be uncoated or scored to assist with dispensing, prepared using necessary pharmaceutical excipients. The active ingredient Glibenclamide is sometimes referred to by its generic synonym, Glyburide, in various international markets.

The general purpose of this agent is to help patients with Type 2 diabetes mellitus effectively control blood sugar levels when dietary changes and regular physical activity alone are inadequate. This medication is taken via the oral route of administration to actively boost the insulin supply in the bloodstream, achieving the critical metabolic objective of reducing hyperglycemia and maintaining long-term glycemic balance.

What side effects are possible with Daonil?

Possible Side Effects and Safety Information

Daonil, which contains Glibenclamide, has an official safety profile primarily defined by its potential to lower blood sugar. All adverse effects and safety notes are derived exclusively from government regulatory documents, such as those published by the FDA and EMA.

Adverse Reaction Classifications

The most prominent and frequently documented adverse reaction is hypoglycemia (low blood sugar), which is typically classified as common or very common in regulatory summaries. Other common adverse effects listed across System-Organ-Classes (SOC) include weight gain and gastrointestinal disturbances (such as nausea and diarrhea).

Officially documented effects are also observed in the Skin and Subcutaneous Tissue (e.g., rash, photosensitivity) and the Blood and Lymphatic System (e.g., rare blood dyscrasias like agranulocytosis).

Serious Safety Considerations

The regulatory label highlights the risk of severe and prolonged hypoglycemia, which may result in coma, as a serious complication. Regulatory documents also note an officially documented increased risk of cardiovascular mortality historically associated with sulfonylureas. Rare but serious effects like aplastic anemia are included in official warnings.

Population and Duration Notes

The safety profile includes specific constraints for high-risk groups. Older adults (geriatric) are noted as being particularly susceptible to hypoglycemia. Patients with severe hepatic (liver) or renal (kidney) impairment are at increased risk of serious, prolonged low blood sugar, leading to formal contraindications in these situations. Time-related patterns state that hypoglycemic events may occur more frequently during the initial month of treatment.

Overdose and Emergency Response

Daonil overdose is primarily characterized by the critical occurrence of severe and protracted hypoglycemia (abnormally low blood glucose). This metabolic event is officially documented as potentially life-threatening and constitutes the drug's most serious overdose manifestation.

Clinical presentations resulting from uncorrected low blood sugar, known as neuroglycopenic sequelae, are detailed in official labeling and include symptoms such as confusion, severe headache, anxiety, drowsiness, and persistent tremor. Progression of severe hypoglycemia can lead to dangerous neurological outcomes, including convulsions, stupor, and coma, carrying the risk of permanent brain damage or death.

Regulatory authorities mandate that immediate medical attention be sought for any severe or protracted symptoms of hypoglycemia, requiring contact with emergency services. Management is focused on prompt glucose or intravenous dextrose administration. Hospital monitoring and observation are officially required for a minimum of 12 hours, even after initial symptom resolution, to prevent delayed relapse. No specific chemical antidote is explicitly named in the regulatory prescribing information.

Specific considerations documented in regulatory labeling note an increased risk of severe, prolonged reactions in patients with underlying hepatic or renal insufficiency. The ingestion of even a single tablet by a young child is also officially documented as a severe exposure risk.

Therapeutic Uses of Daonil

What Daonil Treats: Main Uses and Benefits

Daonil, which contains glibenclamide (also known as glyburide), is applied across therapeutic domains for the management of Type 2 diabetes mellitus. Its primary role is relevant for easing symptoms related to systemic imbalance by addressing blood glucose levels.

The core indication for Daonil involves conditions characterized by periods of heightened symptoms, specifically hyperglycemia (high blood sugar), which may present as symptoms related to physical discomfort or symptoms that interfere with daily functioning. It may be part of symptomatic management in patients with this condition.

Daonil is applied in scenarios where additional management of discomfort is required, and is typically used as an adjunct to diet and exercise in situations where functional stability becomes affected. The overall therapy contributes to easing the overall symptom load and may assist in maintaining a sense of stability when symptoms are more noticeable. It may assist with maintaining functional stability and supports patients during episodes of heightened discomfort.

Quick Fact: Relief for Symptoms related to systemic imbalance

Regulatory References

NIH MedlinePlus Drug Information on Glyburide

Eligibility and Restrictions for Use

Eligibility Profile: Regulatory Information

The eligibility for Daonil (Glibenclamide) is strictly defined by regulatory authorities and is generally restricted to adults (18 years and older) with Type 2 Diabetes Mellitus. Use in the general pediatric population for Type 2 Diabetes is not recommended as safety and efficacy have not been established.

Absolute Contraindications

Official labeling prohibits the use of this medicine in the following populations:

Patients with Type 1 Diabetes Mellitus or Diabetic Ketoacidosis.
Individuals with known hypersensitivity to Glibenclamide, other sulfonylureas, or sulfonamide derivatives.
Patients with Severe Renal Impairment or Severe Hepatic Insufficiency.
Pregnant women (use is contraindicated) and women who are breastfeeding (use is not recommended).
Patients concomitantly treated with the medicine Bosentan.

Restricted or Conditional Use

Use is considered restricted and requires specific caution or monitoring in several populations:

Older Adults (≥ 65 years): The regulatory label advises that dosing must be carefully adjusted.
Mild to Moderate Hepatic or Renal Impairment: Requires strict monitoring and mandatory dose adjustments.
Debilitated or Malnourished Patients: Requires careful monitoring due to the heightened risk of adverse events.
Patients with G6PD enzyme deficiency are generally not recommended to use this medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Daonil (Glibenclamide) documents specific interaction patterns that may alter its efficacy or the concentration of co-administered agents.

A strict contraindication exists for co-administration with Bosentan due to the officially documented increased risk of elevated liver enzymes and hepatotoxicity.

Interactions are primarily classified by their effect on blood glucose. Potentiation of the hypoglycemic action—increasing the risk of low blood sugar—occurs with medicinal products such as NSAIDs, MAOIs, Fluoroquinolone antibiotics, and ACE inhibitors. Conversely, Antagonism of glycemic control—weakening the drug's effectiveness—is documented with agents like Corticosteroids, Thiazide Diuretics, and Oral Contraceptives, which possess intrinsic hyperglycemic activity.

Pharmacokinetic restrictions note that Glibenclamide is metabolized by CYP2C9 and CYP3A4. Rifampicin is identified as an inducer of these enzymes, potentially reducing Glibenclamide exposure and worsening glucose control. Furthermore, Glibenclamide may increase the plasma concentration of Cyclosporine. The ingestion of alcohol is also documented to unpredictably potentiate or weaken the blood glucose-lowering effect. Caution is noted for patients with severe renal or hepatic insufficiency, as these conditions lead to elevated Glibenclamide blood levels and a higher risk of prolonged reactions.

Mechanism of Action

How Daonil Works: Mechanism of Action

Daonil (glibenclamide) functions as an insulin secretagogue, influencing the release of insulin from the pancreatic beta-cell. Its mechanism operates through a defined molecular cascade initiated within the cell membrane.

Targeting the ATP-Sensitive Potassium (K-ATP) Channel

Daonil's primary action is exerted within domains involving receptor-mediated signaling on the beta-cell membrane. It selectively binds to the sulfonylurea receptor 1 (SUR1) subunit of the ATP-sensitive potassium channel (K-ATP), causing the channel to close and inhibiting the outflow of potassium ions (K+). This initial molecular step initiates the change in the cell's electrical potential.

Initiating the Ca²⁺ Signal Transduction Cascade

The closure of the potassium channel causes the beta-cell membrane to depolarize. This voltage change rapidly opens nearby voltage-gated calcium channels, resulting in an influx of calcium ions (Ca²⁺). The Ca²⁺ rise functions as the crucial intracellular messenger.

Endogenous Insulin Release and Physiological Consequence

The increase in intracellular Ca²⁺ concentration initiates the exocytosis of insulin-containing vesicles, leading to an increase in circulating insulin levels. This mechanism facilitates the delivery of the hormone to the circulation.

Dosage and Administration Information

How to Use Daonil

Daonil (glibenclamide) is administered exclusively via the oral route using the tablet formulation, which may be scored to facilitate dose management. The drug is intended for long-term therapy for the chronic management of Type 2 diabetes.

Official Administration Protocol

The protocol for use centers on three key principles: proper timing, controlled dosing, and appropriate frequency.

Usage Principle	Official Labeled Instruction
Timing in relation to food	Must be taken with or immediately before a meal, typically the main meal of the day (e.g., breakfast).
Initial Dosing	Therapy usually begins with a low daily dose, often ranging from 2.5 mg to 5 mg.
Dose Titration and Max	Dosage adjustments are made gradually, usually in small increments (e.g., 2.5 mg) at weekly intervals, with a maximum recommended daily dose of 20 mg.
Dose Frequency	Total daily doses up to 10 mg may be taken as a single administration; amounts exceeding 10 mg must be administered in divided doses.
Special Populations	A lower initial and maintenance dosage is required for older adults and patients with impaired hepatic function.
Missed Dose Rule	A missed dose must not be corrected by subsequently taking a larger dose.

These official instructions define a standardized, controlled approach to administration, emphasizing the importance of meal synchronization and dose adjustment to structure the long-term use of the medicine.

Recent Clinical Evidence

Research Evidence Overview of Studies for Glibenclamide (Daonil)

This overview describes the landscape of clinical research conducted for Glibenclamide (Daonil), detailing the types of studies available, the outcomes they monitored, and where scientific uncertainty remains. This summary is based only on published research and does not offer any personal medical advice.

Evidence for Use in Type 2 Diabetes Mellitus

Research exploring how this medicine was studied for Type 2 Diabetes Mellitus (T2DM) generally involves large-scale, controlled clinical trials. These studies, often Randomized Controlled Trials (RCTs), compare Glibenclamide against placebo or other established therapies. Researchers primarily examined the effect of the medicine on glycemic control biomarkers, such as Glycated Hemoglobin ( HbA1c) and various glucose levels. Studies reported measurements of changes in key glycemic biomarkers. Long-term observational cohorts monitored outcomes reflecting chronic disease progression, such as microvascular and macrovascular events. Research highlights that the measured effect on blood sugar does not appear to increase linearly as the dosage increases beyond a certain level.

Evidence for Use in Gestational Diabetes Mellitus

Glibenclamide was evaluated in Randomized Controlled Trials involving pregnant women diagnosed with Gestational Diabetes Mellitus (GDM). Studies explored short-term changes and focused on maternal and fetal/neonatal outcomes, including birth weight and neonatal hypoglycemia. Studies monitored measurements of maternal blood sugar control, but findings were mixed and inconsistent across different studies concerning specific neonatal outcomes. Research examined data showing patterns related to neonatal hypoglycemia; findings were also evaluated in relation to insulin therapy, and there is uncertainty regarding the precise effects on birth weight across all reports.

Evidence Gaps and Areas of Scientific Uncertainty

Key limitations and areas where certainty remains low include the Dose-Response pattern, which does not appear linear. There is limited information from recent Randomized Controlled Trials comparing Glibenclamide against the newest generation of diabetes medicines. Comparative evidence regarding patterns observed in studies against other similar agents is lacking or is subject to a high degree of variability across studies, particularly in vulnerable groups. Research findings related to neonatal complications in GDM treatment were mixed, meaning subgroup findings are uncertain and require further dedicated research.

Key Studies & References

Intravenous glibenclamide for cerebral oedema after large hemispheric stroke (CHARM): a phase 3, double-blind, placebo-controlled, randomised trial

Frequently Asked Questions (FAQ)

Common questions about Daonil (FAQ)

Q: Is Daonil considered a 'sulfa drug'?

Daonil, which contains Glibenclamide, belongs to the sulfonylurea class of medicines. Regulatory documents indicate that this chemical structure is chemically related to sulfonamides. For this reason, official labeling lists a sulfa allergy or hypersensitivity as a contraindication for use.

Q: What is the difference between Daonil and a drug like Glipizide?

Official regulatory comparisons indicate that both Daonil and Glipizide are classified as second-generation sulfonylureas with similar overall effectiveness. Glipizide is mentioned in regulatory comparisons as having certain considerations for elderly patients or individuals with kidney impairment. This is because official data suggests it may carry a lower risk of prolonged low blood sugar compared to Glibenclamide.

Q: How long after starting Daonil might someone notice an effect?

According to official product information, Glibenclamide is absorbed rapidly after being taken orally. The highest concentration of the drug in the bloodstream, known as the peak concentration, is typically reached in about four hours after the dose is taken.

Q: How quickly does Daonil leave the body after a dose?

The time it takes for the drug to be eliminated is described by its terminal elimination half-life, which ranges from 4 to 11 hours. Official pharmacokinetic data indicates that the elimination of the drug and its related substances is generally complete within 45 to 72 hours.

Q: Are there any neurological side effects listed for Daonil?

Officially documented side effects include effects on the nervous system such as headache and dizziness. Since low blood sugar (hypoglycemia) is the most common adverse effect, these symptoms are often associated with a drop in blood glucose levels.

Q: What are the signs of a severe allergic reaction to Daonil?

Severe allergic reactions (hypersensitivity) may manifest as changes in the skin or breathing. Signs documented in official information can include hives, itching, or a skin rash, as well as swelling of the face or throat, and potentially difficulty breathing.

Q: Are there common over-the-counter medicines that interact with Daonil?

Official regulatory warnings advise caution when combining Daonil with over-the-counter (OTC) medicines. Medicines like aspirin and other common pain relievers may increase the drug's effect of lowering blood sugar. Official warnings highlight the importance of discussing all co-administered products with a healthcare provider.

Q: Can other diabetes medicines be taken at the same time as Daonil?

Yes, Daonil may be used as a combination therapy with other anti-diabetic medications, such as metformin. Official documents indicate that co-administration involves risks that necessitate regular monitoring by a healthcare professional due to the potential for an increased risk of low blood sugar.

Q: Is it safe to take certain vitamins or supplements with Daonil?

Official warnings advise caution regarding dietary supplements and other non-prescription remedies. Official warnings caution that all dietary supplements should be discussed with a healthcare provider, as certain combinations may affect how the body manages blood sugar control.

Q: Can Daonil be used to treat gestational diabetes?

Official labeling typically states that use of the drug is contraindicated in pregnant women. However, the medicine has been evaluated in clinical studies for gestational diabetes. Official information states that its use in this population is generally not recommended and requires discussion with a specialist.

Q: Are there any restrictions on operating machinery while using Daonil?

Regulatory information notes that patients should be aware of the potential for hypoglycemia to affect concentration while driving or operating machinery. This caution is noted because low blood sugar (hypoglycemia) is a common adverse effect that can impair alertness.

Q: Is Daonil ever prescribed for purposes other than diabetes?

The official regulatory indication for Daonil is exclusively for the treatment of Type 2 diabetes mellitus. Although research has explored the drug's use for non-diabetic purposes like neuropathic pain, its regulatory approval remains confined to diabetes treatment.

Q: What is the risk profile of Daonil compared to older generations of similar drugs?

Daonil is classified as a second-generation sulfonylurea derivative. Regulatory documents indicate that the first-generation drugs in this class, such as Tolbutamide, are no longer actively used in clinical practice due to historical safety profiles.

Q: What kind of monitoring (like blood tests) is typically required when taking Daonil?

Regulatory labels specify that regular measurement of glucose levels in blood and urine is necessary. The determination of glycated hemoglobin (HbA1c), which provides an average measure of blood sugar control over time, is also noted in official information.

Q: Is it possible to develop a tolerance to Daonil over time?

The term 'tolerance' is not used in official regulatory evidence. However, research into long-term effects suggests that the pancreatic beta-cells may, over time, demonstrate a reduced ability to secrete insulin in response to the drug.

Q: Is it normal to feel dizzy when first starting Daonil?

Dizziness is a potential symptom of low blood sugar (hypoglycemia), which is the most common adverse effect associated with the medicine. Official product information notes that these hypoglycemic events may occur more frequently during the initial month of treatment.

Q: What happens in the body when Daonil is taken for many years?

Official safety documents address risks such as long-term cardiovascular mortality. Furthermore, research indicates that the pancreatic beta-cells may, after many years of treatment, experience a loss of insulin secretory capacity. This loss of function is a factor that may be considered when a change to insulin therapy is being discussed.

How should Daonil be stored and disposed of?

How to Store and Dispose of Daonil (Glibenclamide)

Storage Requirements

Daonil tablets must be stored under specific regulatory conditions to maintain stability. The medicine must be kept at room temperature, specifically below 25°C (77°F), and must be protected from freezing or refrigeration. To ensure integrity, the product must be stored in a dry place, protected from light, and kept in the original container, which should be tightly closed. For safety, the medicine must be kept out of the sight and reach of children.

Disposal Instructions

Disposal of unused or expired Daonil must be done in accordance with local requirements for medicinal waste. The official labeling specifies that the product should not be disposed of via wastewater or routine household trash. Patients should consult their pharmacist for appropriate disposal methods and scratch out all identifying information on the container before discarding.

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