Mellozzan (Melatonin): Uses, Dosage & Side Effects

What Is Mellozzan and What Is It Used For?

Mellozzan contains melatonin, a hormone naturally produced by the pineal gland located deep within the brain. Under normal conditions, the body increases melatonin production in the evening as darkness falls, signaling to the brain and body that it is time to prepare for sleep. This natural melatonin surge peaks during the middle of the night and declines toward morning, helping to maintain a healthy circadian rhythm — the internal clock that governs the 24-hour sleep-wake cycle.

When this circadian rhythm is disrupted — whether by rapid travel across multiple time zones or by neurological conditions such as ADHD — the timing of natural melatonin release can become misaligned with the desired sleep schedule. Mellozzan provides exogenous (externally supplied) melatonin to help re-synchronize the body's internal clock with the local time or desired bedtime.

Jet Lag in Adults

Mellozzan is indicated for the short-term treatment of jet lag in adults. Jet lag occurs when you travel rapidly across several time zones, causing a temporary mismatch between your body's internal clock and the local day-night cycle at your destination. Symptoms typically include difficulty falling asleep, daytime sleepiness, fatigue, impaired concentration, digestive disturbances, and general malaise. Mellozzan is particularly recommended for travelers crossing five or more time zones, especially when flying eastward, as eastward travel tends to produce more severe jet lag symptoms. If you have experienced jet lag during previous trips, you are more likely to benefit from melatonin supplementation on future journeys.

According to the Cochrane Database of Systematic Reviews (2002, updated), exogenous melatonin taken close to the target bedtime at the destination can significantly reduce jet lag symptoms. The evidence is strongest for flights crossing five or more time zones, with eastward travel showing the greatest benefit. The American Academy of Sleep Medicine (AASM) also recognizes melatonin as a therapeutic option for circadian rhythm sleep-wake disorders related to jet lag.

ADHD-Related Sleep Disorders in Children and Adolescents

Mellozzan is also approved for the treatment of insomnia in children and adolescents aged 6 to 17 years who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), but only when non-pharmacological sleep hygiene measures have proven insufficient. Sleep problems are extremely common in children with ADHD, affecting an estimated 25–50% of patients. These children often have difficulty falling asleep due to delayed melatonin onset, hyperarousal, or the effects of stimulant medications used to treat ADHD.

The European Medicines Agency (EMA) has evaluated melatonin for this indication and found it to be effective in reducing sleep onset latency (the time it takes to fall asleep) in children with ADHD. Multiple randomized controlled trials, including a landmark study published in the Journal of the American Academy of Child and Adolescent Psychiatry, have demonstrated that melatonin significantly reduces sleep onset latency and increases total sleep time in children with ADHD-related insomnia, with a favorable safety profile.

The oral solution formulation of Mellozzan is particularly advantageous for pediatric use, as it allows precise dose adjustments in small increments using the graduated dosing syringe provided. This is especially important because optimal melatonin doses vary considerably between individual children, and the lowest effective dose should always be used.

What Should You Know Before Taking Mellozzan?

Contraindications

You must not take Mellozzan if you are allergic (hypersensitive) to melatonin or any of the other ingredients in the oral solution. The excipients include glycerol (E 422), methylparaben (E 218), potassium sorbate (E 202), hydrochloric acid (for pH adjustment), and purified water. Methylparaben is a preservative that may cause allergic reactions, potentially delayed, in some individuals. If you have previously experienced an allergic reaction to any product containing parabens, you should avoid Mellozzan and discuss alternative melatonin preparations with your healthcare provider.

Warnings and Precautions

Before using Mellozzan, you should speak with your doctor or pharmacist if you or your child has any of the following conditions, as special monitoring or dose adjustments may be necessary:

• Diabetes or impaired glucose tolerance: Melatonin can increase blood sugar levels. If you have diabetes, you should not eat for 2 hours before or after taking Mellozzan. Regular blood glucose monitoring is advisable, and your diabetes medication may need adjustment.
• Liver disease: Mellozzan is not recommended for patients with liver problems. Melatonin is primarily metabolized in the liver by CYP1A2 and CYP2C19 enzymes, and impaired liver function can lead to significantly elevated melatonin levels in the blood, increasing the risk of adverse effects.
• Kidney disease: Caution should be exercised when giving Mellozzan to patients with kidney impairment. While melatonin metabolites are primarily excreted via the kidneys, limited data exist on the safety profile in this population.
• Autoimmune conditions: If your immune system attacks your own body tissues (autoimmune disease), you should discuss the risks with your doctor before starting Mellozzan. Some laboratory studies suggest melatonin may have immunomodulatory effects, though the clinical significance of this remains uncertain.
• Epilepsy: Melatonin may increase or decrease the frequency of seizures. If you or your child has epilepsy, close monitoring is essential, especially when starting treatment or adjusting the dose.

Children and Adolescents

For the jet lag indication, Mellozzan must not be given to anyone under 18 years of age, as the safety and efficacy have not been established in this age group for this use. For the treatment of sleep disorders associated with ADHD, Mellozzan should not be given to children under 6 years of age. The treating physician should regularly review the ongoing need for treatment, with check-ups recommended at least every six months. An annual treatment break should also be considered to assess whether continued melatonin therapy is still necessary.

Pregnancy and Breastfeeding

Mellozzan is not recommended if you are pregnant or think you may be pregnant. Melatonin crosses the placenta, and there is insufficient clinical data to determine whether it poses a risk to the developing fetus. Animal studies have not conclusively established the safety of exogenous melatonin during pregnancy. If you become pregnant while taking Mellozzan, discontinue the medication and consult your healthcare provider immediately.

Mellozzan is likewise not recommended during breastfeeding. Endogenous melatonin is naturally present in breast milk and follows a circadian pattern, with higher concentrations at night. Exogenous melatonin supplementation may alter these natural patterns, and the potential effects on the nursing infant have not been adequately studied. The decision to breastfeed while taking Mellozzan should be made in consultation with your healthcare provider, weighing the benefits of treatment against the potential risks to the infant.

Driving and Operating Machinery

Mellozzan can cause drowsiness. If you experience this side effect, you should not drive or operate machinery. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness. Drowsiness may persist into the morning, especially at higher doses, and patients should be aware of this possibility when planning activities that require full concentration.

How Does Mellozzan Interact with Other Drugs?

Melatonin is primarily metabolized by the liver enzyme CYP1A2, with additional involvement of CYP2C19. Any substance that inhibits or induces these enzymes can significantly alter melatonin blood levels, either increasing the risk of side effects or reducing therapeutic efficacy. Below is a comprehensive overview of the most clinically relevant drug interactions.

Major Interactions

The following interactions are considered clinically significant and may require dose adjustments, enhanced monitoring, or avoidance of concurrent use:

Moderate and Minor Interactions

The following interactions are generally manageable with appropriate monitoring but should still be reported to your healthcare provider:

Caffeine, Smoking, and Alcohol

Caffeine: Caffeine is a CYP1A2 substrate and may compete with melatonin for metabolism. High caffeine intake can alter melatonin blood levels, though the clinical effect is variable between individuals. It is generally advisable to limit caffeine consumption in the evening when using Mellozzan.

Smoking: Tobacco smoking induces CYP1A2 enzyme activity, which can significantly reduce melatonin blood levels. This means that smokers may require higher doses of Mellozzan to achieve the same therapeutic effect. If you start or stop smoking during treatment, inform your doctor, as a dose adjustment may be necessary.

Alcohol: Do not consume alcohol in conjunction with Mellozzan. Alcohol reduces the effectiveness of melatonin on sleep quality and can worsen next-day drowsiness. Additionally, alcohol disrupts the natural sleep architecture, counteracting the intended therapeutic benefit of Mellozzan.

What Is the Correct Dosage of Mellozzan?

Always use Mellozzan exactly as your doctor or pharmacist has instructed. The oral solution comes with a 5 ml graduated dosing syringe (0.1 ml increments), allowing precise dose measurement. Since 1 ml of solution contains 1 mg of melatonin, the volume in milliliters corresponds directly to the dose in milligrams.

Adults with Jet Lag

Mellozzan should be taken at the intended bedtime at your destination when traveling across at least 5 time zones. The effect is most pronounced for eastward travel, where the circadian disruption is typically greater. If the starting dose of 2 mg does not provide sufficient relief, the dose may be increased to a maximum of 5 mg. Conversely, if you experience excessive drowsiness the next morning, reduce the dose. The oral solution should not be taken before 8:00 PM or after 4:00 AM at your destination, as taking it outside this window may delay circadian adaptation rather than accelerate it.

Children and Adolescents (6–17 Years) with ADHD

Treatment should always begin with the lowest possible dose. The prescribing physician will individualize the dose through small incremental increases over time, based on the child's clinical response and tolerability. The lowest effective dose should always be maintained. Regular follow-up visits (recommended at least every 6 months) are essential to evaluate whether the treatment remains appropriate and effective. An annual treatment break should be considered to assess whether continued melatonin therapy is still necessary, as some children may outgrow their sleep difficulties or develop effective sleep habits through behavioral interventions.

How to Take Mellozzan

Mellozzan should be swallowed directly from the dosing syringe. Follow these steps for proper administration:

1. Open the bottle by removing the cap.
2. Insert the dosing syringe into the bottle adapter.
3. Turn the bottle upside down and slowly pull the plunger to measure the prescribed dose, reading the measurement at the top edge of the plunger.
4. Remove the syringe from the bottle.
5. The patient should be sitting upright. Direct the syringe tip toward the inside of the cheek.
6. Push the plunger slowly, allowing the patient to swallow naturally. Rapid administration may cause discomfort.
7. Clean the inside of the syringe after each use.

Missed Dose

If you or your child forgets to take a dose and wakes up during the night, the missed dose can still be taken, but not later than 4:00 AM. Do not take a double dose to make up for a forgotten dose. If it is close to your normal wake-up time, simply skip the missed dose and resume the regular dosing schedule the following evening.

Overdose

If you or your child takes more than the recommended daily dose of Mellozzan, or if a child accidentally ingests the medication, contact a healthcare provider, hospital emergency department, or poison control center immediately for assessment and advice. Symptoms of overdose may include excessive drowsiness, dizziness, nausea, and headache. While melatonin is generally considered to have a wide margin of safety, medical evaluation is recommended following any suspected overdose, particularly in children.

Stopping Treatment

There are no known harmful effects when Mellozzan treatment is stopped or discontinued. Melatonin is not known to cause dependence or withdrawal symptoms. However, you should always discuss any changes to your medication regimen with your healthcare provider before stopping treatment.

What Are the Side Effects of Mellozzan?

Like all medicines, Mellozzan can cause side effects, although not everyone experiences them. The following side effects have been reported with melatonin use. They are organized by frequency to help you understand how likely each effect is to occur.

Most side effects of Mellozzan are mild to moderate in intensity and tend to resolve on their own as the body adjusts to the medication. Headache and drowsiness are the most frequently reported effects, which is consistent with the pharmacological action of melatonin. If drowsiness persists into the morning, consider reducing the dose or taking Mellozzan earlier in the evening.

Long-term safety data from clinical trials in children with ADHD suggest that melatonin is generally well tolerated with continued use. A systematic review published in Pediatrics found no significant adverse effects on growth, development, or pubertal maturation with melatonin use over periods of up to 3.7 years. However, as with any medication, ongoing monitoring is important, and any new or worsening symptoms should be reported to your healthcare provider.

How Should You Store Mellozzan?

Proper storage of Mellozzan is important to ensure the medication remains effective and safe throughout its shelf life. Follow these storage guidelines:

• Keep out of sight and reach of children. The oral solution should be stored in a secure location to prevent accidental ingestion by young children.
• Expiry date: Do not use Mellozzan after the expiry date printed on the bottle after "EXP." The expiry date refers to the last day of the stated month.
• After opening: Mellozzan can be used for up to 6 months after the bottle has been opened. Note the date of first opening and discard the solution 6 months later, even if there is remaining solution in the bottle.
• Temperature: No special temperature storage conditions are required. Room temperature storage is appropriate.
• Light protection: Keep the solution in the original amber glass bottle with the cap firmly closed. Melatonin is light-sensitive, and exposure to light may degrade the active ingredient.
• Disposal: Do not dispose of Mellozzan via wastewater or household waste. Return unused or expired medication to your pharmacy for safe disposal. This helps protect the environment.

What Does Mellozzan Contain?

Active Ingredient

The active substance is melatonin, present at a concentration of 1 mg per milliliter of oral solution. Melatonin (chemical name: N-acetyl-5-methoxytryptamine) is a neurohormone that is structurally related to serotonin and is synthesized from the amino acid tryptophan.

Inactive Ingredients (Excipients)

Appearance and Packaging

Mellozzan is a clear, colorless to slightly yellowish oral solution. It is supplied in a 100 ml amber glass bottle fitted with a white aluminum cap. Each package includes a graduated dosing syringe with a capacity of 5 ml and markings at 0.1 ml intervals, allowing precise measurement of doses from 0.1 ml (0.1 mg) to 5 ml (5 mg). The amber glass protects the light-sensitive melatonin from photodegradation.