Melaxen

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Melaxen

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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 Melaxen

Quick Facts Overview

Property Description
Active ingredient Melatonin (INN)
Form Oral tablets (including slow-release)
Pharmacological class Chronobiotic Agent / Neurohormone
General purpose Regulation of the Sleep-Wake Cycle
Origin Synthetic (Exogenous)

Definition and Pharmacological Class

Melaxen is a pharmaceutical preparation that primarily functions as a chronobiotic agent, containing the neurohormone melatonin as its sole active ingredient. Melatonin, the International Nonproprietary Name (INN), is an indoleamine derivative chemically known as N-acetyl-5-methoxytryptamine. This compound is structurally identical to the endogenous hormone naturally secreted by the pineal gland. The preparation belongs to the high-level pharmacological classification of miscellaneous anxiolytics, sedatives, and hypnotics, although its mechanism focuses on synchronization rather than broad central nervous system depression.

As a brand, Melaxen provides an exogenous supply of melatonin, typically a synthetic compound manufactured for consistent potency. Its core purpose is recognized clinically for its ability to influence the timing and function of the body's internal clock, thereby regulating the circadian rhythms.


Composition, Origin, and Dosage Form Differentiation

Melaxen is administered via the oral route of administration and is supplied as an oral solid dosage form, such as a tablet or hard capsule, mixed with standard solid pharmaceutical excipients. The active ingredient is a monocomponent substance. A distinguishing feature in the preparation of melatonin products is the release mechanism; specialized formulations, such as slow-release tablets, are designed to sustain the concentration of the active agent over a prolonged duration, which is intended to better support sleep maintenance.

This specific approach to drug delivery aims to replicate the body’s natural, extended nocturnal release profile. The drug is frequently available as an Over-The-Counter (OTC) preparation in numerous global markets, positioning it as an accessible option for those seeking to regulate their sleep timing.

Regulatory References

  1. Melatonin: What You Need To Know

What side effects are possible with Melaxen?

Possible side effects and safety information

The official safety profile for Melaxen, which contains the neurohormone melatonin, is structured by adverse reactions classified according to their frequency and the physiological system affected. The most frequently documented effects are categorized as Common, meaning they are expected to occur in 1 to 10 out of every 100 individuals.

Frequency and System-Organ Classifications

Common adverse reactions typically reported in regulatory documents include headache, somnolence (sleepiness), nasopharyngitis, back pain, and arthralgia (joint pain). Less frequent reactions, classified as Uncommon, span Psychiatric disorders (e.g., irritability, anxiety, abnormal dreams), Nervous system disorders (e.g., dizziness), and Gastrointestinal disorders (e.g., nausea, dry mouth).

Serious Reactions and Safety Constraints

The regulatory label documents potentially serious reactions, including Rare events such as leucopenia, thrombocytopenia, and angina pectoris, as well as hypersensitivity reactions (e.g., angioedema, classified as Not Known frequency).

Safety statements in regulatory labeling identify specific populations and conditions where caution or exclusion is advised. Use is generally restricted in individuals with severe hepatic (liver) impairment and is not recommended for those with autoimmune diseases due to a lack of clinical data. Caution is also advised in patients with renal (kidney) impairment, epilepsy, and diabetes mellitus/glucose intolerance. Due to the potential for somnolence, caution is noted regarding activities requiring mental alertness following administration.

Overdose and Emergency Response

The official regulatory profile for Melaxen (melatonin) overdose is defined by an exaggeration of its expected pharmacological effects and documented severe systemic complications. All overdose information is presented at a high, regulatory-aligned descriptive level.

Documented Overdose Manifestations

System Clinical Signs
Central Nervous System Excessive drowsiness, prolonged sedation, confusion, headache, dizziness.
Systemic/Cardiovascular Hypotension (low blood pressure), tachycardia (increased heart rate), hypothermia.
Gastrointestinal Nausea, vomiting, diarrhea.

The primary manifestations represent an extension of the drug’s action, leading to CNS depression and documented effects across the cardiovascular and gastrointestinal systems.

Emergency Actions and Supportive Management

Immediate medical attention must be sought in all cases of suspected overdose. Contact emergency services if the person exhibits severe or life-threatening symptoms, including difficulty breathing, seizures, or the inability to wake up fully (loss of consciousness). Public health reports specifically highlight pediatric overdose as a significant concern, noting the potential for serious outcomes in children, often following accidental ingestion of flavored formulations.

Management is strictly symptomatic and supportive treatment. Official regulatory documents state that no specific antidote is known for melatonin overdose. Clinical protocols may involve continuous monitoring of vital signs and potential procedures such as gastric lavage or the administration of activated charcoal. Hospital monitoring is required until the patient's condition has stabilized.

Therapeutic Uses of Melaxen

What Melaxen Treats: Main Uses and Benefits

This therapeutic area is commonly used across conditions characterized by periods of heightened symptoms related to the sleep-wake cycle. Melaxen is primarily relevant for managing symptom clusters that create noticeable functional strain. This includes addressing chronic issues like Delayed Sleep-Wake Phase Disorder (DSWPD), situational challenges such as Jet Lag Disorder, and sleep disruption due to Shift Work.

The therapeutic domain of primary insomnia is relevant to specialized melatonin formulations. It is commonly used to help with symptoms related to the abnormal timing of the body’s rest cycle. The use offers symptomatic relief that helps patients cope more steadily with symptom fluctuations.

“It is commonly used to help with symptoms related to the abnormal timing of the body’s rest cycle.”

The use supports patients by contributing to easing the overall time required to fall asleep and assists with maintaining functional stability during periods of acute or episodic misalignment.


Quick Fact: Supportive Management for Sleep Timing

Symptom Domain Clinical Context Patient Benefit
Delayed Sleep Onset Primary Insomnia Contributes to easing the overall time required to fall asleep.
Circadian Misalignment Jet Lag Disorder Assists with maintaining functional stability during symptomatic periods.
Episodic Fatigue Shift Work Disorder Supports patients in coping more steadily with temporary symptom load.

Regulatory References

  1. European Medicines Agency’s overview

Eligibility and Restrictions for Use

Who can and cannot use Melaxen?

Eligibility for using Melaxen is strictly defined by regulatory documents, which establish population groups allowed to use the medicine and those who must not. This information is based on official prescribing information.

Absolute Exclusions (Contraindicated) The medicine is strictly contraindicated for any individual with a known hypersensitivity to the active substance or any excipient in the formulation. Use is also prohibited in patients with certain rare hereditary metabolic conditions, such as galactose intolerance.

Age-Related Eligibility Use is officially established for adults aged 55 years and over for primary insomnia (specific formulations) and for adults across all ages for jet lag. Specific formulations are approved for children and adolescents aged 6 to 17 years for insomnia associated with neurodevelopmental disorders. For general insomnia, safety and efficacy have not been established in the pediatric population (under 18).

Physiological and Comorbidity Restrictions Use is not recommended in patients with severe hepatic (liver) impairment due to altered drug clearance. It is also not recommended for women who are pregnant, intending to become pregnant, or breastfeeding, due to a lack of sufficient clinical data. Caution is advised in patients with general renal impairment and those with autoimmune diseases.

What should I know about interactions with other medicines?

Interaction Scope

The official regulatory documents define the product's interaction profile across pharmacokinetic (PK) and pharmacodynamic (PD) domains, setting constraints on co-administration with various medicinal products and substances.

Category Official Regulatory Information
Specific interacting medicines (if explicitly listed) Fluvoxamine, Oestrogens, Cimetidine, Quinolones, Carbamazepine, Rifampicin, Zolpidem, Warfarin, Imipramine, Thioridazine, 5- or 8-methoxypsoralen.
Mechanistic basis of interactions (only if stated in label): PK inhibition (CYP1A2, CYP2C19, CYP1A1, CYP2D), PK induction (CYP1A2), PD enhancement of sedative properties, Alteration of anticoagulation activity.
Timing-based interaction rules (if applicable): Alcohol should not be taken with the product [EMA SmPC].
Population-specific interaction notes (if applicable): Patients on Oestrogens (e.g., in hormone replacement therapy or contraceptives) are identified as having increased Melaxen plasma levels due to enzyme inhibition.
Interaction-related restrictions: Co-administration with Fluvoxamine is strictly advised to be avoided due to significant exposure increase.

Resulting Interaction Structure

Official Interaction Statements:

  • The combination with Fluvoxamine is advised to be avoided due to the drug's strong inhibition of CYP1A2 and CYP2C19, which is documented to increase Melaxen exposure up to 17-fold.
  • Other inhibitors of Melaxen's metabolism, including Oestrogens, Cimetidine, and Quinolones, are also officially documented to increase plasma concentrations.
  • Conversely, CYP1A2 inducers such as Carbamazepine and Rifampicin, as well as Cigarette Smoking, may lead to reduced plasma levels.
  • Co-administration with Benzodiazepines, non-benzodiazepine hypnotics (Zolpidem), Imipramine, or Thioridazine is associated with an enhancement of sedative or other CNS-related pharmacodynamic effects.
  • The regulatory label states that Alcohol reduces the product's effectiveness on sleep, and its consumption is advised against.
  • An alteration of the anticoagulation activity of Warfarin is officially documented as an interaction risk.

This structure reflects how regulatory documents define the product’s interaction structure by classifying risks related to metabolic pathway modulation and additive central nervous system effects, establishing specific constraints on co-use.

Mechanism of Action

How Melaxen Works: A Multi-Pathway Regulator


Modulation of Key Circadian Rhythm Pathways

Melaxen functions as an agonist at the high-affinity melatonin receptors, primarily MT1 and MT2, located within the Suprachiasmatic Nucleus (SCN) of the hypothalamus. This interaction initiates or suppresses signaling sequences crucial for the phase-shifting of the endogenous circadian rhythm and modulates pathways that influence the timing of the sleep-wake cycle.


Influence on Core Body Thermoregulation

Binding to the MT1 receptor subtype is critical in systems that govern thermoregulation, triggering peripheral vasodilation. This specific physiological cascade results in a decrease in core body temperature, affecting the thermal environment of the SCN, a necessary factor in regulating the diurnal rest phase.


Direct and Indirect Free-Radical Scavenging

Beyond its receptor-mediated activity, Melaxen acts as an antioxidant capable of scavenging various free-radical species, directly engaging with numerous Reactive Oxygen and Nitrogen Species (ROS/RNS). This molecular action limits the impact of excessive mediator activity, which influences pathways affected by cellular oxidative stress.

Dosage and Administration Information

Melaxen (melatonin) is administered via the oral route for all labeled indications. Administration protocols are strictly defined by the dosage form and the target condition, and they are always limited to a once daily frequency.


Administration Protocols

For Insomnia in Older Adults

The 2 mg prolonged-release tablet, often used for short-term primary insomnia in adults aged 55 and over, is administered 1 to 2 hours before bedtime. It is a mandatory procedural instruction that the tablet must be taken after food to ensure the intended extended-release profile. The tablet must be swallowed whole with fluid and should not be crushed, chewed, or divided. The treatment course is typically restricted to a duration of up to thirteen weeks.

For Jet Lag

For the short-term treatment of jet lag, the dose is generally 3 mg using an immediate-release tablet, taken once daily at the local bedtime on arrival at the destination. The official guidelines specify that the dose should not be taken before 8:00 PM or after 4:00 AM local time to avoid disruption of the body's synchronization process. This regimen is restricted to a maximum of five days. If a dose is missed, it is recommended to simply take the next scheduled dose at the usual time and not to double the dose.

Population Constraints

The medicine is not recommended for patients with moderate to severe hepatic impairment due to potential alterations in drug clearance. Furthermore, its use is generally not recommended in the pediatric population (under 18 years) for primary insomnia.

Recent Clinical Evidence

Melaxen: Recent Clinical Evidence

This section summarizes the key research evidence that has investigated the drug's effects and the findings regarding symptom changes across various clinical settings.

Primary Indications: Sleep Disorders

Research has primarily focused on the drug's role in addressing conditions related to the circadian rhythm, such as jet lag and primary insomnia. The most robust evidence relates to jet lag, where studies suggest its administration, timed close to the destination's target bedtime, is associated with a reduction in jet lag severity, particularly when crossing five or more time zones.

For insomnia, clinical trial results remain mixed, with some meta-analyses reporting a statistically significant, yet modest, reduction in sleep onset time and an increase in total sleep time. However, other systematic reviews indicate the clinical benefit is uncertain, and findings may depend on the specific type of insomnia or underlying conditions.

Extended Research Areas

Beyond sleep, studies have explored the drug’s use as an adjunctive therapy in specialized populations:

  • Ulcerative Colitis (UC): Controlled trials have investigated the combination in patients with mild to moderate UC, reporting on improvements in certain clinical indices and some quality-of-life measures, such as general health and energy.
  • Chronic Pain/Comorbidities: Research is ongoing to examine the drug's role in conditions where chronic sleep disturbance is present, including some chronic pain conditions. Observational studies have also reported on the drug's use in patients with chronic cerebral ischemia, noting subjective improvements in sleep quality.

Safety Profile Reporting

The safety profile is continually evaluated in study participants. Common adverse events reported across trials typically include headache, dizziness, and daytime drowsiness. Long-term cardiovascular safety data remains an area of ongoing research, and certain patient groups (such as those taking anticoagulants) require careful consideration.

Key Studies & References

  1. National Institute for Health and Care Excellence (NICE) Guideline on Sleep Disorders

Frequently Asked Questions (FAQ)

Common questions about Melaxen (FAQ)

Q: How quickly can a person expect Melaxen to start working?

Official product information indicates that the active ingredient, melatonin, has a hypnotic or sedative effect that increases the propensity for sleep. The immediate-release formulation is eliminated from the body relatively quickly, with an elimination half-life typically ranging from 20 to 60 minutes.


Q: Is it necessary to take Melaxen at the exact same time every day?

Regulatory documents emphasize taking the medicine within a specific time window to align with the body's natural cycle. For primary insomnia, this window is 1 to 2 hours before bedtime. For jet lag, strict time boundaries are set (not before 8:00 PM or after 4:00 AM local time) to help synchronize the body's clock.


Q: Are there any specific foods I must avoid when taking Melaxen?

The regulatory label advises that alcohol should not be consumed with the product, as it reduces its effectiveness on sleep. Official administration protocols state that the prolonged-release tablet is administered after food to ensure the medicine is released slowly into the body as intended.


Q: What should a patient do if they suspect they are having a severe or rare side effect?

Safety statements advise that patients should be monitored closely for any unusual or severe changes, including emotional changes or signs of an allergic reaction. If a serious event is suspected, regulatory information strongly advises immediate contact with a healthcare professional or emergency services.


Q: Can Melaxen be taken simultaneously with another type of medicine to manage the same condition?

Co-administration with other medicines that affect the central nervous system, such as benzodiazepines or hypnotics, is associated with an enhancement of sedative effects. This means that combining the medicines may lead to stronger central nervous system-related effects than taking either alone.


Q: Are there any known long-term safety concerns or side effects associated with Melaxen?

For its primary approved use in primary insomnia, the treatment course is generally restricted to a maximum of thirteen weeks. Official research evidence notes that the safety profile is continuously evaluated, and long-term cardiovascular safety data remains an area of ongoing research.


Q: Does Melaxen have any documented risk of dependence or addiction?

Official product information indicates that the medicine is generally considered unlikely to cause dependence after repeated use.


Q: Can I drink coffee while using Melaxen?

Regulatory documents list that substances that inhibit certain drug-metabolizing enzymes in the body can increase the plasma concentrations of Melaxen. Such substances may increase the amount of the medicine in the blood.


Q: Can the effectiveness of Melaxen decrease or wear off after using it for a long period?

Official safety profiles indicate that patients are generally considered unlikely to experience reduced response, often called tolerance, to the medication after repeated use.


Q: Why is Melaxen often mentioned in online discussions alongside sleep or anxiety aids?

The medicine belongs to the high-level pharmacological classification of miscellaneous anxiolytics, sedatives, and hypnotics. This regulatory classification links it to other medicines used for similar issues, although its primary function is the synchronization of the sleep-wake cycle.


Q: What color are Melaxen tablets? (Packaging/appearance)

According to the regulatory Public Assessment Report, the tablets are generally described as white to off-white film-coated tablets.


Q: Why do some users report that Melaxen did not work for them?

Official clinical trial results regarding the effectiveness of Melaxen for insomnia are described as mixed. Regulatory information indicates that findings may depend on the specific type of insomnia or underlying medical conditions experienced by the patient.


Q: Is it true that Melaxen contains [controversial ingredient]?

The active ingredient in the medicine is Melatonin, which is structurally identical to the hormone produced naturally by the body. According to the regulatory composition report, the medicine is a monocomponent substance that is typically synthesized artificially for consistent potency.


Q: Does Melaxen affect fertility?

Official prescribing information states that the use of Melaxen is generally not recommended for women who are intending to become pregnant. This caution is advised due to a lack of sufficient clinical data regarding use in this specific population.


Q: Are there differences in how Melaxen works between adult men and women?

Regulatory documents note a specific interaction with Oestrogens, which are present in hormone replacement therapy or contraceptives. Patients taking Oestrogens are identified as having increased Melaxen plasma levels due to enzyme inhibition, indicating a pharmacokinetic difference in certain populations.


Q: Is there a maximum effective dose for Melaxen described in official documents?

Regulatory documents define the approved dose strengths for labeled indications, which are generally 2 mg for the prolonged-release formulation and 3 mg for the immediate-release formulation.


Q: Are there any known withdrawal symptoms associated with stopping Melaxen?

Regulatory safety profiles indicate that the medicine is generally considered unlikely to cause dependence. There are no specific warnings in the label regarding withdrawal symptoms.

How should Melaxen be stored and disposed of?

How to Store and Dispose of Melaxen

The storage and disposal of Melaxen (melatonin) must strictly adhere to regulatory requirements to preserve product stability and ensure public safety.

Official Storage Conditions

Melaxen must be stored at a temperature not exceeding 25°C (77°F), which often corresponds to Controlled Room Temperature. The product must be stored in the original package to ensure it is protected from light and moisture. Maintaining these conditions is necessary to keep the medicine stable up until the expiry date printed on the packaging.

Handling and Disposal Rules

For child safety, the medicine must be kept out of the sight and reach of children. When disposing of unused or expired Melaxen, it must not be thrown away via wastewater or household waste as this is prohibited by official regulations. Instead, disposal must be conducted according to local requirements, typically by returning it to a pharmacist for proper pharmaceutical waste handling.

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

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