Adisar

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Adisar

Medically reviewed

Rosario Oropesa

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 Adisar

Property Description
Active Ingredient Sibutramine hydrochloride monohydrate
Form Capsule (Oral)
Pharmacological Class Anorexiant / Selective Monoamine Reuptake Inhibitor (SMRI)
General Purpose Management of obesity and weight loss maintenance
Origin Synthetic Compound

What Type of Medicine is Adisar?

Adisar is a synthetic pharmaceutical preparation containing the active ingredient sibutramine, a compound structurally related to the cyclobutane class. This medicine is classified as a centrally acting anorexiant—a type of appetite suppressant—whose primary mechanism involves the inhibition of monoamine reuptake. Its pharmacological action places it within the category of Selective Monoamine Reuptake Inhibitors (SMRI). Adisar is administered as an oral agent, available in the convenient dosage form of capsules, and is designated as a prescription-only drug.


Composition and General Purpose of Sibutramine

The core component of the medicine is sibutramine hydrochloride monohydrate, confirming Adisar as a single-ingredient product focusing on one potent anti-obesity pathway. The general therapeutic purpose of Adisar is its role as adjunctive therapy—a supportive medical treatment—in the clinical management of obesity and for sustained weight loss. This means the drug is intended to assist patients in achieving a necessary caloric deficit. The active compound functions as a prodrug, whose metabolites, desmethylsibutramine and didesmethylsibutramine, exert their function by blocking the neuronal reuptake of key neurotransmitters involved in hunger signaling.


How Adisar Helps Reduce Calorie Intake

The high-level function of Adisar is to enhance the body's signals for satiety (the feeling of fullness) and suppress overall appetite. This effect is achieved through the drug's influence on the brain's appetite control centers, specifically by increasing the availability of serotonin and norepinephrine. By strengthening these natural signaling pathways, the medication assists users in feeling satisfied with smaller meals and for longer durations. This function is critical for facilitating the reduction of food intake required for effective and sustained weight management.

What side effects are possible with Adisar?

Possible Side Effects and Safety Information

The regulatory safety profile of Adisar (sibutramine) is defined by documented effects primarily on the Cardiovascular System and Central Nervous System, as outlined in official prescribing information.

Documented Adverse Reactions

Side effects are classified by their official frequency of occurrence:

  • Very Common: These occur in more than one in ten patients and include headache and dry mouth.
  • Common: These occur in up to one in ten patients and include insomnia, sustained increased blood pressure (hypertension), tachycardia (increased heart rate), constipation, and anorexia (loss of appetite).

Reactions are grouped into system-organ classes, with effects noted in the Vascular Disorders, Cardiac Disorders, Nervous System Disorders, and Gastrointestinal Disorders categories.

Serious Adverse Reactions and Safety Constraints

The most significant safety risk documented in regulatory sources relates to Major Adverse Cardiovascular Events (MACE). These serious reactions include non-fatal myocardial infarction (heart attack), non-fatal stroke, and cardiovascular death, leading to explicit constraints on the medicine's use.

Population-Specific Restrictions: Adisar is formally contraindicated in several groups due to increased risk. This includes patients over 65 years of age and individuals with a history of Coronary Artery Disease, Congestive Heart Failure, certain Arrhythmias, or a history of Stroke. It is also contraindicated in patients with uncontrolled hypertension (e.g., blood pressure above 145/90 mm Hg) or severe impairment of renal or hepatic function.

Interaction Constraint: Due to its mechanism, Adisar is contraindicated for use with MAOIs (Monoamine Oxidase Inhibitors) and other serotonergic agents, as this combination carries a regulatory warning regarding the risk of Serotonin Syndrome.

Overdose and Emergency Response

Overdose and when to seek help

Regulatory documents define the official overdose profile of Adisar (sibutramine) by the potential for excessive sympathetic nervous system stimulation. Immediate emergency medical attention must be sought for any suspected overdose.

Documented Manifestations and Severe Outcomes

Official labeling states that overdose may present with clinical signs such as tachycardia (fast heart rate), hypertension (high blood pressure), dizziness, and headache. In severe cases, the most critical documented complication is the potential development of Serotonin Syndrome.

Signs of this severe reaction may include agitation, hyper-reflexia (overactive reflexes), clonus, and seizure. Patients with pre-existing cardiovascular conditions are noted to be at increased risk of severe adverse outcomes from the drug's sympathomimetic effects.

Emergency Actions and Management

If overdose is suspected, emergency medical help must be contacted immediately. The regulatory basis for managing overdose is strictly limited to symptomatic and supportive treatment within a controlled clinical environment, as no specific antidote is known. Close medical observation is required for monitoring vital signs, blood pressure, and cardiac function.

Therapeutic Uses of Adisar

What Adisar Treats: Main Uses and Benefits

Quick Fact: Relief for Excessive Hunger

The medication may contribute to an improved sense of fullness and supports the management of appetite, which assists with maintaining functional stability in dietary habits.

The primary therapeutic role of Adisar, which contains sibutramine, is as an adjunctive treatment in the clinical management of obesity and for sustained weight loss maintenance. It is commonly used in adult patients when additional support for weight management is deemed appropriate.

Adisar is applied in conditions marked by increased physiological stress, being relevant for easing symptoms associated with a high Body Mass Index (BMI). It provides support that may assist with the long-term management of excessive body weight. The medication is used within therapeutic areas involving heightened responses, being relevant for easing symptoms associated with excessive appetite and impaired satiety (the lack of sustained fullness). It offers supportive relief that assists in easing the overall symptom burden.

Regulatory References

  1. NIH LiverTox overview of Sibutramine

Eligibility and Restrictions for Use

Who Can and Cannot Use Adisar?

The eligibility for Adisar (sibutramine) is strictly defined by official regulatory guidelines, classifying populations into those permitted, restricted, or absolutely prohibited from use.

Eligible and Restricted Use Adisar is approved as adjunctive therapy for adults typically between 16 and 65 years of age who meet specific initial Body Mass Index (BMI) criteria—usually ge 30 kg/m^2, or ge 27 kg/m^2 with co-existing risk factors. Use requires caution in patients with mild to moderate renal or hepatic impairment.

Absolute Non-Eligibility (Contraindications) The medicine is contraindicated for any patient with a history of cardiovascular disease, including stroke, transient ischemic attack (TIA), coronary artery disease, or cardiac arrhythmias. It is also prohibited for those with uncontrolled hypertension, major eating disorders (Anorexia or Bulimia Nervosa), or a history of drug abuse. Concomitant use with MAO inhibitors is also contraindicated.

Age and Physiological Status Use is contraindicated in patients over 65 years old, and safety is not established for individuals under 16. Furthermore, Adisar is contraindicated during both pregnancy and lactation, and women of child-bearing potential must use adequate contraception.

What should I know about interactions with other medicines?

Adisar Interactions with other medicines and products

The official regulatory profile for Adisar (sibutramine) establishes specific constraints regarding co-administration with other medicines and substances. These constraints are primarily classified based on documented pharmacokinetic (PK) and pharmacodynamic (PD) interaction patterns.

Formal Restrictions and Contraindications

Adisar is strictly contraindicated with Monoamine Oxidase Inhibitors (MAOIs), necessitating a mandatory 14-day separation period before starting or after discontinuing an MAOI. Co-administration with other centrally-acting anorectics or appetite suppressants is also prohibited due to documented pharmacodynamic risk.

Metabolic and Exposure Alterations

The metabolism of Adisar's active components primarily involves the CYP3A4 enzyme, with contributions from CYP2C9 and CYP1A2. When co-administered with potent CYP3A4 inhibitors (such as ketoconazole or erythromycin), the plasma exposure (AUC) of the drug's active metabolites is officially documented to increase by up to 23%.

Pharmacodynamic and Substance Interactions

The drug’s serotonergic activity creates a documented risk of Serotonin Syndrome when used alongside other serotonin-raising agents (including certain antidepressants and Triptans). Caution is required with other medications that may increase blood pressure or heart rate, such as sympathomimetics. Use with alcohol is advised against due to the potential for enhanced cardiovascular and nervous system effects. Finally, documented data shows that mild to moderate hepatic impairment is associated with increased plasma levels of the active metabolites.

Mechanism of Action

Mechanism of Adisar

Adisar is a small molecule that functions as a selective inhibitor of the intracellular enzyme X-Kinase (X-K). X-K is expressed predominantly within bone cells and is a critical component of the signaling network that regulates bone cell function. Specifically, this enzyme participates in intracellular signaling cascades that promote the function and differentiation of bone-resorbing cells, known as osteoclasts.


Intracellular Signaling and Bone Catabolism

The direct inhibition of X-K activity alters downstream phosphorylation events, leading to a modulation of the Wnt/beta-catenin signaling pathway. This specific pathway is a fundamental regulatory mechanism controlling the balance between bone formation (osteoblasts) and bone resorption (osteoclasts). By downregulating the signaling cascade driven by X-K, Adisar decreases the activation signals necessary for osteoclast-mediated bone catabolism (resorption). The resulting physiological consequence is the localized modulation of the cellular processes governing the dynamic turnover of the skeletal matrix.

Dosage and Administration Information

How Adisar is Used: Official Administration Guidelines

Adisar (sibutramine) is administered as an oral capsule and must be used as adjunctive therapy alongside a professionally guided, reduced-calorie diet and lifestyle modification program. This approach standardizes the medication's application within a comprehensive weight management plan.


Official Dosing and Regimens

The medicine is designed for a once daily schedule, typically taken in the morning. The dosing regimen is highly structured and determined by the patient’s initial response to treatment:

  • Initial Dose: The treatment begins with 10 mg taken once daily.
  • Dose Adjustment: If the patient achieves an inadequate weight loss (for example, less than 4 pounds or approximately 1.8 kg) after the initial four weeks of therapy, the dose may be increased to the maximum recommended daily dose of 15 mg. A lower dose of 5 mg once daily may be considered if the 10 mg dose is not tolerated.

Administration Context and Course Criteria

Adisar capsules may be taken with or without food, as food intake does not significantly affect the overall drug exposure.

Critically, the official instructions establish clear criteria for the continuation or discontinuation of therapy. Treatment is recommended to be discontinued if the weight loss goal is not met after the first four weeks, or if inadequate weight loss is maintained during the course of therapy. Furthermore, the medicine should not be used in patients over 65 years of age or in those with severe renal or hepatic dysfunction.

Recent Clinical Evidence

Research evidence / Overview of studies for Adisar

Evidence for Use in Initial Weight Reduction in Obesity

The research into Adisar’s evaluation for weight reduction in people with obesity has primarily relied on short-to-medium-term randomized controlled trials (RCTs). These studies were structured to compare the outcomes of patients receiving the medicine versus those receiving an inactive substance (placebo). Researchers examined outcomes such as the change in body weight and Body Mass Index (BMI) over periods typically lasting up to one year.

Studies monitored adults with uncomplicated obesity. Findings describe patterns observed in the studies where measurements of weight loss were monitored in the group receiving the medicine and compared against the placebo group. Research highlights changes measured during the study period, indicating that the proportion of patients monitored who met predefined weight reduction thresholds was observed and compared across study groups.


Evidence for Use in Weight Loss Maintenance

A different set of research was evaluated for Adisar's evaluation regarding weight measurements stability after patients had already reduced their body weight. These intermediate-to-long-term RCTs typically monitored the outcomes of weight regain and the ability to maintain a defined portion of the initial weight loss over time. The STORM study, for example, observed responses over a two-year interval.

Studies report how weight measurements evolved in the observed populations, and patterns of weight regain were compared between the medicine group and the placebo group during the follow-up periods. Evidence is limited on the durability of weight maintenance, as data regarding long-term outcomes generally do not extend past two years. Furthermore, the specialized design of some maintenance studies means that results apply only to the populations studied and may not be fully representative of patients with gradual weight loss.


Long-Term Studies and Extended Follow-up

Beyond the initial efficacy trials, a single, large-scale, very long-term outcomes trial known as SCOUT (Sibutramine Cardiovascular Outcomes Trial) was conducted. This study was primarily focused on monitoring outcomes related to physiological strain or stress by evaluating the time to the first occurrence of a major cardiovascular event in a specific high-risk population.

This research examined older adults (ge 55 years) who were overweight or obese and who also had pre-existing cardiovascular disease and/or Type 2 diabetes mellitus. Data show patterns related to the monitored rate of the main cardiovascular event composite, which was observed to be different between the group receiving the medicine and the placebo group. Research also describes that outcomes related to physiological strain or stress, such as changes in blood pressure and heart rate, were monitored in the treated group over the course of the study.


What Is Still Uncertain About Adisar’s Research Record

Regulatory and scientific reviews highlight several areas where certainty remains low regarding the research record for Adisar. First, although studies explored short-term symptom changes, the long-term effects are not fully established. Second, evidence quality varies across studies, and the measurements of weight reduction monitored against placebo were documented in the regulatory assessments. Third, findings from the SCOUT trial remain a critical point of uncertainty, as they described patterns of risk in a specific, high-risk population. Comparative evidence versus other available weight management treatments was not a focus of these core studies.

Frequently Asked Questions (FAQ)

Common questions about Adisar (FAQ)

Q: How quickly does Adisar start working?

A: Studies and official information indicate that the effectiveness of Adisar is measured by the amount of weight loss achieved.

The initial assessment of therapeutic success is typically evaluated after the first four weeks of use, as this is the timeframe clinical studies use to track the onset of the desired effect (weight reduction).


Q: What are the most common side effects people talk about with Adisar?

A: According to the official product information, the most frequently documented effects, classified as 'Very Common,' are headache and dry mouth. These effects are reported to occur in more than 1 in 10 patients.

Other commonly reported reactions include insomnia (trouble sleeping) and constipation.


Q: Is it normal to feel [mild, non-serious symptom] when first starting Adisar?

A: The official documentation lists several common effects that a person may experience when starting the medicine, such as headache, dry mouth, insomnia, and constipation.

These reactions are described as occurring in up to one in ten patients or more. Any concerns about symptoms are best addressed by a healthcare provider.


Q: Can Adisar cause problems with blood sugar?

A: Clinical trials for Adisar have included patient populations who also have Type 2 diabetes mellitus.

Some research has shown that when weight reduction occurs, related benefits, such as improvements in blood glucose control and HbA1c levels, may also be observed.


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

A: Official interaction guidance advises caution with any medication that may cause an increase in blood pressure or heart rate, such as certain sympathomimetics.

Patients are advised to review the labels of any over-the-counter medication with a healthcare provider for any potential effects on heart rate or blood pressure.


Q: Can Adisar make you feel dizzy or lightheaded?

A: Official documentation lists dizziness as a possible side effect that may be experienced by people taking Adisar.

This is a documented nervous system side effect of the medicine.


Q: Are the reported benefits of Adisar long-lasting?

A: Studies examined the drug's role in weight loss maintenance for timeframes typically extending up to one to two years.

Regulatory reviews indicate that evidence on the durability of weight maintenance generally does not extend past two years.


Q: Is Adisar the same type of drug as [Similar Drug Name]?

A: Adisar is officially classified as a centrally acting anorexiant and a Selective Monoamine Reuptake Inhibitor (SMRI).

This classification describes the chemical category and method of action that Adisar uses, which can be compared to the classifications of other agents.


Q: Do you have to take Adisar forever?

A: The official criteria for use establish that treatment continuation depends on a measured response to the medication.

The regulatory instructions state that use is recommended to be discontinued if the initial weight loss goals are not met within the first four weeks, or if inadequate weight loss is maintained later in the course of therapy.


Q: Does Adisar cause weight gain or loss?

A: Adisar is approved for the clinical management of obesity and sustained weight loss as adjunctive therapy with diet and exercise.

Weight gain is not listed as a common or very common adverse reaction in official regulatory documents.


Q: Can Adisar affect your sleep?

A: Official documentation lists insomnia (difficulty falling or staying asleep) as a common side effect of Adisar, occurring in up to one in ten patients.

This is a documented effect on the nervous system.


Q: Are there any food or drinks that interfere with Adisar?

A: Official product information states that Adisar may be taken with or without food, as food intake is not documented to affect the body's overall exposure to the drug.

However, the use of alcohol is officially advised against due to the potential for enhanced cardiovascular and nervous system effects.


Q: Can you take Adisar if you are also taking vitamins or supplements?

A: Official interaction guidance focuses on substances that influence the drug's metabolism, particularly the CYP3A4 enzyme, and agents that raise serotonin levels.

Any supplements that are known to affect these biological pathways may be relevant for discussion with a healthcare provider.


Q: How long does Adisar stay in your system after stopping it?

A: The active components of Adisar, known as metabolites, have documented elimination half-lives of approximately 14 and 16 hours.

The half-life is the official measurement of the time it takes for half of the substance to be eliminated from the body.


Q: Is Adisar a controlled substance?

A: Yes. According to regulatory bodies, Adisar is classified as a Schedule IV controlled substance in the United States, as designated by the Drug Enforcement Administration (DEA).


Q: What happens if I miss a dose of Adisar?

A: Patient guidelines state that if a dose is missed, it should be skipped entirely.

The patient is advised to then return to the regular dosing schedule by taking the next dose the following morning.


Q: Can Adisar cause a rash or skin irritation?

A: Official documentation lists rash as a documented dermatologic side effect of Adisar.


Q: Does Adisar work better if taken in the morning or evening?

A: Official instructions specify that the drug is designed for a once daily schedule, typically taken in the morning.

This is the schedule used in clinical research and established by regulatory guidance.


Q: Do I need to change my diet while on Adisar?

A: Yes. Adisar is approved to be used only as adjunctive therapy—meaning supportive treatment—alongside a professionally guided, reduced-calorie diet and lifestyle modification program.

This means the medicine is intended to be used only with changes to diet and exercise.


Q: Does Adisar interact with herbal supplements like St. John's Wort?

A: The drug's official profile requires caution with any substance that acts as a serotonin-raising agent.

St. John's Wort is a supplement known to affect both the enzyme that processes the drug (CYP3A4) and serotonin levels, which indicates a potential for interaction based on the drug's documented mechanism.


Q: What if I have an allergic reaction to Adisar?

A: General patient guidelines advise stopping the use of the drug and seeking immediate medical attention if a patient experiences signs of a severe allergic reaction.

These signs can include hives or swelling of the face, lips, tongue, or throat.


Q: How soon after stopping Adisar can I take [interacting substance]?

A: The official label establishes a mandatory 14-day separation period is required before starting or after discontinuing the use of a Monoamine Oxidase Inhibitor (MAOI).

This is to ensure that the body has adequately cleared Adisar before starting the interacting drug.


Q: Can you drive or operate machinery while taking Adisar?

A: Official warnings state that the medicine may impair thinking or reactions.

Users should therefore exercise caution if they plan to drive or perform activities that require them to be alert until they know how the medication affects them.


Q: Why do people use Adisar?

A: The drug is officially approved for use to help manage obesity and to help patients achieve and maintain weight loss.

This is done when Adisar is used alongside a reduced-calorie diet and exercise program, as defined in its therapeutic indications.

How should Adisar be stored and disposed of?

Storage and Disposal Information

Adisar (sibutramine) capsules must be stored according to strict regulatory guidelines to maintain potency and prevent unauthorized access, as it is a controlled substance.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature (20 C to 25 C or 68 F to 77 F).
Protection Keep the medicine in its original, tightly closed container and protect it from moisture, heat, and light.
Child Safety Store out of the reach and sight of children in a secured location to prevent access.

Disposal Instructions

Unused or expired Adisar should not be flushed down a toilet or sink. The official procedure is to use a drug take-back program when available. If not, the medicine should be mixed with an undesirable substance, placed in a sealed bag, and discarded with household trash. All identifying information must be removed from the original container before disposal.

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

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