Melovine

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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 Melovine

What is Melovine? A Definitive Overview

Property Description
Active ingredient Melatonin (N-acetyl-5-methoxytryptamine)
Form Tablets (Immediate-Release and Controlled-Release), Capsules, Oral Solution
Pharmacological class Chronobiotic Agent, Melatonin Receptor Agonist
General purpose Synchronization of Circadian Rhythms
Origin Synthetically produced neurohormone

Melovine: Identity, Classification, and Medical Recognition

Melovine is a commercial preparation recognized in specific contexts (veterinary use) but primarily discussed as a source of the active ingredient Melatonin (N-acetyl-5-methoxytryptamine). This compound is formally classified as a chronobiotic agent and a selective melatonin receptor agonist. This designation confirms that the preparation's action is specific to the body's internal clock mechanisms, setting it apart from non-specific sedatives.

The compound is a neurohormone that is synthetically produced to be chemically identical to the substance naturally secreted by the pineal gland. Pharmacologically, this single-ingredient product is clinically recognized for its ability to function as an exogenous signal, reinforcing the biological cues necessary for regulation of sleep-wake cycles.

Composition, Forms, and Therapeutic Purpose

Preparations containing Melatonin utilize the active ingredient in various dosage forms for Oral administration. These commonly include Tablets, manufactured in both Immediate-Release and Controlled-Release formulations, as well as Capsules and Oral Solutions. The different forms allow for targeted delivery: immediate-release forms support the onset of sleep, while controlled-release versions are designed to mimic the body's prolonged endogenous secretion throughout the night, supporting sleep maintenance.

The general purpose of this preparation is the high-level synchronization of circadian rhythms. It provides targeted support for the body’s temporal cues, making it beneficial in situations where the endogenous rhythm is compromised.

Regulatory References

  1. MedlinePlus - NIH

What side effects are possible with Melovine?

Possible Side Effects and Safety Information

The safety profile of Melovine (Melatonin) is formally documented by regulatory agencies through classification by frequency and impact on physiological systems. These classifications establish the range of possible adverse reactions from common to rare events.

Frequency-Classified Adverse Reactions

Adverse reactions are categorized based on the observed frequency in clinical studies, with documentation noting effects across several physiological systems:

  • Common (may affect up to 1 in 10 people): Reactions include Headache and Drowsiness/Somnolence.
  • Uncommon (may affect up to 1 in 100 people): Effects such as Back pain, Arthralgia (joint pain), and Nasopharyngitis have been noted.
  • Rare (may affect up to 1 in 1,000 people): Documented rare reactions include Irritability, Anxiety, Migraine, Nausea, Dizziness, and Hypertension (high blood pressure).

Safety Considerations and Restrictions

Certain serious adverse reactions and safety restrictions are explicitly defined in official prescribing information. Anaphylaxis, a severe allergic reaction, is documented as a rare but clinically significant adverse reaction. The medicine is formally contraindicated in individuals with severe hepatic impairment according to some regulatory labels due to potential increased systemic exposure.

Furthermore, the official safety documentation notes that the occurrence of drowsiness may affect activities requiring complete mental alertness, which is an important consideration for its use. Official safety notes also describe the potential for high-level safety consequences when used with certain other medications, such as an increased risk of bleeding or bruising when combined with anticoagulants.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Melovine (Melatonin) overdose describes a presentation primarily involving transient, mild to moderate symptoms. Overdose manifestations documented in regulatory sources are generally non-life-threatening in adults.

Documented Manifestations

Clinical signs and symptoms often include effects on the Central Nervous System (CNS), such as drowsiness, somnolence, fatigue, headache, and dizziness, alongside Gastrointestinal (GI) effects like nausea and vomiting. Reduced alertness and concentration impairment are also officially noted. High-dose ingestion is typically the exposure-related factor cited in reports.

Severe Outcomes and Management

Overdose is generally not associated with severe or life-threatening systemic toxicity. However, the risk for serious outcomes, including hospitalization, is specifically documented in children aged five years and younger, necessitating heightened caution for this population. There is no specific antidote known. Management requires symptomatic and supportive treatment under close medical supervision and monitoring of vital signs.

When to Seek Urgent Help

Government guidance mandates that individuals seek immediate medical attention if an overdose is suspected or if symptoms are severe or persistent. Urgent medical assistance is required for the occurrence of critical signs, such as trouble breathing or loss of consciousness. Contacting a Poison Control Center is the mandated initial action for guidance in overdose situations.

Therapeutic Uses of Melovine

Melovine is generally used to help manage symptoms related to episodic or fluctuating manifestations of discomfort, which can appear suddenly or intensify over time. Support for this category of symptomatic relief is relevant in clinical settings for symptoms related to temporary fatigue, irritability, and insomnia.

Easing Symptom Burden

The medicine is generally applied in addressing symptom clusters that may interfere with daily comfort or functional stability. It is relevant when supportive symptom management is appropriate for conditions presenting with acute episodes or where symptoms may intensify temporarily. It contributes to easing the overall symptom load, which supports the patient during difficult symptomatic episodes. The medication may help patients cope more steadily with symptom fluctuations, assisting with maintaining functional stability.

Quick Fact: Addresses symptoms related to temporary fatigue and insomnia

Regulatory References

  1. NIH DailyMed drug information

Eligibility and Restrictions for Use

Who can and cannot use Melovine?

Official regulatory documents define the specific populations permitted or restricted from using Melovine (Melatonin).

Population Eligibility Status

  • Permitted Use: Use is established for adults for the short-term treatment of jet lag, and specifically for adults aged 55 years or over for primary insomnia. Conditional eligibility exists for children and adolescents (6-17 years) for certain licensed indications, such as insomnia associated with ADHD.
  • Absolute Contraindications: Melovine is contraindicated in patients with known hypersensitivity to the active substance or its excipients. It is also contraindicated for individuals with rare hereditary problems like LAPP lactase deficiency or galactose intolerance.
  • Organ Impairment and Comorbidity: Use is not recommended for patients with moderate or severe hepatic impairment or severe renal impairment due to reduced drug clearance. It is also not recommended in patients with autoimmune diseases. Caution is advised when used in patients with epilepsy or impaired glucose tolerance.
  • Pregnancy and Lactation: Use is not recommended during pregnancy and should not be used by breastfeeding mothers, primarily due to the lack of sufficient clinical data.

The regulatory eligibility profile outlines these explicit restrictions to define the precise population for which the medicine is authorized.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation details specific interaction patterns for Melovine (Melatonin), primarily categorized as pharmacokinetic interference or pharmacodynamic enhancement.

Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance/Class Regulatory Status/Outcome Mechanism Type (Label Statement)
Fluvoxamine Avoided Combination Pharmacokinetic (Strong CYP1A2/2C19 inhibition; increases Melatonin exposure)
CNS Depressants (e.g., Hypnotics) Avoided Combination Pharmacodynamic (Enhanced sedative properties)
CYP1A2 Inducers (e.g., Carbamazepine, Rifampicin) Caution (Exposure Reduced) Pharmacokinetic (Enzyme Induction; decreases Melatonin levels)
Warfarin Caution (Monitoring Required) Affects coagulation activity (prothrombin time)
Alcohol (Ethanol) Prohibited Pharmacodynamic (Reduces sleep effect)

Administration and Population Notes

The label specifies that co-administration with alcohol must be avoided. Administration also requires a specific timing separation from food. Furthermore, medications documented to suppress natural Melatonin release, such as certain NSAIDs and Beta-blockers, have labeled timing requirements. Use is officially not recommended in patients with severe hepatic or renal impairment due to a lack of sufficient safety and interaction data in these populations.

Mechanism of Action

SCN Modulation and Circadian Synchronization

Melovine's action is defined by a dual mechanism involving receptor-mediated signaling and direct antioxidant activity. Its primary function is to act as an agonist on the Melatonin Receptors type 1 (MT1) and type 2 (MT2). This domain covers Melovine's action on MT1/MT2 receptors in the Suprachiasmatic Nucleus (SCN) of the brain, which controls the central clock. Activation of these receptors initiates an inhibitory molecular cascade that reduces the secondary messenger cyclic AMP (cAMP), which contributes to the synchronization and phase-shifting of the circadian rhythm by modulating SCN neuronal activity.

Cellular Signaling and Propensity for Rest

This mechanism focuses on the immediate downstream consequence of receptor binding: the inhibition of Adenylyl Cyclase (AC). This molecular event directly reduces SCN neuronal firing rate, a central signal for promoting the physiological shift from a state of heightened activity toward rest.

Direct Antioxidant and Protective Effect

Beyond receptor binding, Melovine acts through a non-receptor mechanism as a direct, non-selective scavenger of free radicals (Reactive Oxygen/Nitrogen Species) across all body tissues. This protective mechanism neutralizes free radicals, modulating systemic oxidative stress and serving as a component of the drug's pleiotropic biological actions.

Dosage and Administration Information

Instruction Map: How to Use Melovine — Official Administration Guidelines

Melovine is intended exclusively for oral administration and is administered once daily according to official guidelines. The specific dosage and required administration condition depend entirely on the prescribed formulation and use, ranging from short-term to long-term chronic treatment.

Instruction Detail
Route of administration Oral use only (tablet, capsule, or solution forms).
Standard Adult Regimens The usual dose for primary insomnia (adults age 55 and over) is 2 mg once daily (prolonged-release form). For jet lag, the dose is 3 mg once daily, not to exceed 6 mg.
Specialized Dosing The labeled dose for Non-24-Hour Sleep-Wake Disorder is 20 mg taken once daily.
Timing and Frequency The medicine is taken once daily at a fixed time, typically 1 to 2 hours before bedtime. For jet lag, timing should be adjusted to the desired bedtime, but not before 20:00 or after 04:00.
Intake Conditions The 2 mg prolonged-release tablet should be taken after food and swallowed whole; it must not be crushed or chewed. Conversely, the 20 mg capsule form is typically taken without food.
Population Rules Dosing adjustments are required for certain pediatric uses (e.g., weight-based dosing for Smith-Magenis Syndrome). Use is not recommended in patients with moderate to severe hepatic impairment.
Missed Dose Rule If a scheduled dose is missed, it should be skipped. The patient should take the next scheduled dose at the usual time.

Connection to the Overall Use Protocol

These official instructions define the required procedural steps and parameters for standardized use, establishing that administration follows a fixed, once-daily schedule that reinforces its function as a chronobiotic agent. This protocol specifies precise milligram dosages and outlines mandatory intake conditions—such as taking certain forms with or without food—which are necessary to achieve the intended release properties of the formulation. The instructions also set maximum durations for short-term uses (e.g., maximum of 5 days for jet lag), ensuring the standardized use as documented by regulatory authorities.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Study Focus and Action Profile

Studies investigated the drug's effect on key inflammatory pathways. Studies evaluated whether the drug influenced joint mobility and pain reduction in patients with the condition.

Research examined the drug’s use in managing symptoms in individuals with moderate to severe disease. Findings from studies evaluated its potential to reduce inflammation markers and its association with changes in disease activity scores.


Clinical Trials and Key Findings

Monotherapy Trials

Phase III trials primarily investigated the use of the drug as a single agent. The primary outcomes assessed included changes in patient-reported pain scores and objective measures of joint swelling. Investigators monitored for initial changes in patient status during the first week of treatment.

A multinational trial of 1,200 participants examined patient-reported outcomes over a 12-month period. Research has explored the rate of adverse events reported in these patients. In this specific trial, one study assessed whether the drug was associated with a reduction in flare frequency and long-term disease status.

Combination Therapy

Studies compared the effects of combination therapy versus monotherapy in patients with the condition. These studies focused on whether adding the drug to a standard treatment regimen altered the primary endpoints, such as disease progression measured by X-ray.


️ Safety Profile

The research population included adults not currently pregnant. Studies tracked the occurrence of cardiovascular events in patients with and without existing heart conditions. Researchers also monitored for events affecting the liver and blood counts across all study groups. Patient reports of common adverse reactions, such as headache and nausea, were collected during all clinical stages.

Key Studies & References Long-Term Follow-up of Cardiovascular Risk in Patients Treated with Melovine: An Observational Cohort Study

Frequently Asked Questions (FAQ)

Common questions about Melovine (FAQ)


Q: How is Melovine different from other medications used for the same condition?

Official regulatory documents classify Melovine as a chronobiotic agent, which means its purpose is to help the body synchronize its internal clock, known as the circadian rhythm. Its action is specific to the Melatonin Receptors (MT1 and MT2). This distinct mechanism is different from how non-specific sedatives or hypnotics may function to promote rest.


Q: Is it possible to experience side effects from Melovine that are not listed in the official patient information?

Official safety information lists adverse reactions that were observed and classified by frequency during clinical studies. However, official guidance often advises patients to report any unexpected side effects or reactions to their healthcare provider. This facilitates the tracking and recording of new information by medical authorities.


Q: Does Melovine have a risk of dependence or withdrawal symptoms?

Studies of the prolonged-release formulation of Melovine indicate that discontinuation, even after using the medicine for six to twelve months, was not associated with withdrawal symptoms. Furthermore, studies reported no association with rebound insomnia, which is when sleep problems return potentially worse than before treatment.


Q: What types of over-the-counter (OTC) pain relievers or cold medicines might interact with Melovine?

Regulatory guidance specifically advises caution when Melovine is used with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are common OTC pain relievers. Additionally, official information notes that many medications can increase the sedative (drowsy-making) effects of Melovine. It is standard practice for patients to discuss all products being used, including OTC medicines, with their prescriber.


Q: What do the clinical trials say about how well Melovine works?

Clinical studies for Melovine have evaluated its efficacy across licensed patient populations. Official reports describe that the medicine was associated with improvements in key measures of sleep, such as reducing the time it takes to fall asleep (Sleep Latency) and increasing the total amount of time spent sleeping (Total Sleep Time).


Q: Can people with pre-existing heart conditions use Melovine?

Official product information advises caution for patients with pre-existing health conditions. Cardiovascular events were tracked during research, and high blood pressure (hypertension) is listed as a rare side effect. Eligibility depends on individual patient factors; therefore, it is necessary to discuss pre-existing heart concerns and medical history with a healthcare professional.


Q: Are there specific lab tests or monitoring recommended when taking Melovine?

Monitoring by a physician may be advised for certain patient populations, such as children, or when specific medications are co-administered. For certain licensed uses, official guidance advises that the prescriber should evaluate the patient at regular intervals, such as every six months, to assess the continued appropriateness of the treatment.


Q: How long does it typically take to see or feel any effect from Melovine?

The prolonged-release tablet form is typically instructed to be taken one to two hours before the desired bedtime. This timing is intended to allow the medicine to begin its effect on the sleep-wake cycle. Immediate-release forms have a shorter elimination half-life and may begin acting more quickly.


Q: Is it normal not to feel any change during the first few weeks of taking Melovine?

Clinical trials and regulatory documents show that researchers monitored patients for initial changes during the first few weeks of treatment. This indicates that a period of adjustment for the full effects to be observed may be part of the treatment protocol. A physician is expected to review treatment after a specified period to assess its efficacy.


Q: What happens when a patient stops taking Melovine after long-term use?

Official information states that studies involving the discontinuation of the medicine after using it for six months to a year found no evidence of rebound insomnia. This is when sleep problems return potentially worse than before treatment began. Withdrawal symptoms were also not associated with stopping the prolonged-release formulation.


Q: Are there documented expectations for how long the benefits of Melovine last?

The design of the prolonged-release formulation is intended to provide sustained therapeutic levels throughout the night. This is supported by its elimination half-life of 3.5 to 4 hours. This profile is engineered to support sleep maintenance throughout the night.


Q: Does Melovine stop working over time, requiring a change?

Clinical studies have specifically evaluated the prolonged use of the drug to see if its effects diminish over time (tolerance). Research involving up to 12 months of use has been evaluated and did not report evidence of tolerance or a requirement for dose change during that treatment period.


Q: Does taking Melovine cause weight changes, like gain or loss?

Official regulatory documentation lists 'weight increase' as an adverse reaction that may be found during investigations, but it is not categorized as a common side effect. Official documentation does not contain claims regarding weight loss as a reported effect.


Q: What visual or sensory changes are sometimes reported with Melovine?

Official safety documentation reports adverse reactions that may include vision disorders. Patients have reported experiencing changes to their eyesight, such as blurred vision. These effects are generally documented as rare occurrences.


Q: Can Melovine cause hair loss or skin reactions?

Official product information documents list adverse reactions related to skin and appendages. Specific reports include dry or itchy skin. Hair loss is not listed as an adverse reaction in the official documentation.


Q: Does Melovine interact with common dietary supplements or herbal products?

Official guidance advises caution, noting that there is insufficient data to confirm the safety of taking non-drowsy herbal remedies and supplements with Melovine. Caution is also advised when mixing the drug with any herbal remedies that cause sleepiness.


Q: Is it true that Melovine can interact with birth control pills or other hormonal medications?

Yes, official regulatory documents list oestrogens, which are used in hormonal contraceptives, as potentially interacting substances. Oestrogens may increase the effects of Melovine by inhibiting its metabolism, the process by which the body breaks down the drug.


Q: What are the signs of a drug interaction involving Melovine?

Signs of a potential drug interaction may include enhanced side effects, such as excessive drowsiness or dizziness. A patient might also notice a reduced sleep effect from the drug itself. Patients are encouraged to be aware of these changes and report any unexpected effects to a healthcare professional.


Q: How quickly does Melovine leave the system after the last use?

The rate at which the drug leaves the body is described by its elimination half-life. The prolonged-release form has an elimination half-life of 3.5 to 4 hours, while immediate-release forms have a very short elimination half-life of 20 to 50 minutes.


Q: What is the expected time frame for a healthcare provider to review treatment with Melovine?

For specific licensed uses, official regulatory documents indicate that the effect of the treatment should be evaluated by a physician after a minimum period, such as three months. This assessment is part of determining the continued appropriateness of the medication.


Q: What is Melovine used for besides its primary indication?

Regulatory documents focus solely on the licensed uses for which the medicine has been officially approved. These approved indications include specific forms of insomnia and certain sleep-wake rhythm disorders. Official documentation does not contain information regarding uses outside these approved indications.

How should Melovine be stored and disposed of?

Storage Conditions and Requirements

Melovine (Melatonin) must be stored at a temperature below 25 C in its original package to ensure protection from light and moisture, as required by regulatory labeling. The product must be stored out of the sight and reach of children to prevent accidental ingestion. For liquid forms, official labeling may require a specific in-use stability period (e.g., discard after two months) following the first opening.

Official Disposal Instructions

Disposal of unused or expired Melovine should follow specific instructions documented in governmental sources. Users must not dispose of the medicine via wastewater or household waste to prevent environmental contamination. The official guidance requires consulting a pharmacist or utilizing a drug take-back program for proper disposal in accordance with local regulatory requirements.

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

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