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Dosage Recommendations

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click to open accordion Where to use

Melatonin is used in Circadian rhythm-related sleep disorders, which involve either difficulty in falling asleep, waking up during the sleep cycle, or waking up too early and being unable to fall back sleep.1 1. Zhdanova IV, Tucci V. Melatonin, Circadian Rhythms, and Sleep. Curr Treat Options Neurol. 2003 May;5(3):225-229. doi: 10.1007/s11940-003-0013-0.

click to open accordion When to use

Melatonin is to be consumed before bedtime or as recommended.

click to open accordion What are the side effects?

While side effects of Melatonin are generally mild, you may experience mild transient next-day drowsiness. No withdrawal effects.

click to open accordion Safety advice

Melatonin has been reported to increase the effects of warfarin in some patients. Considerations if the patient is taking any other medications.

FAQs

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click to open accordion What is Melotryp™? What does it contain?

Melotryp™ is a dietary Melatonin supplement that contains 3 mg of Melatonin in each 0.25 g tablet.

click to open accordion What is the source of Melatonin in Melotryp™? Is it vegetarian or non-vegetarian?

• Melatonin in Melotryp™ is derived synthetically.

• 100% vegetarian.

click to open accordion What is Melatonin and how does it play a role in maintaining circadian rhythm?

Melatonin is a hormone that is naturally secreted by the pineal gland located in the epithalamus of the human brain. It acts as a time cue for the biological systems and regulates the sleep-wake cycle/circadian rhythm in the human body.[1,2]

click to open accordion What is the mechanism of action of Melatonin?

• Photopigments in the retina sense the light/dark environment.[3]

• The signals are transduced to suprachiasmatic nuclei (SCN) in the hypothalamus.[3]

• SCN transfers the signal to the pineal gland.[3]

• The pineal gland synthesizes Melatonin through a series of reactions as a response to darkness.[3] Note: Darkness stimulates Melatonin secretion and light inhibits the same.[3]

• Melatonin uptake occurs in different tissues of the body through Melatonin receptors. After the uptake, Melatonin starts its action— induces sleepiness, scavenges free radicals, and so on. It majorly regulates the sleep-wake cycle/circadian rhythm in the human body.[3]

click to open accordion How Melatonin levels decline as we age and how exogenous Melatonin can help?

The decrease in Melatonin levels with age might be due to:

• The degenerative alterations in the central clock, i.e. SCN that regulates Melatonin secretion from the pineal gland.[22]

• Reduced daily exposure to environmental light that stimulates SCN to send the signals to pineal gland for secreting Melatonin.[22]

• The pineal gland simply does not store and release Melatonin as effectively due to calcification.[22]

− Helps restore the decreased Melatonin levels in the blood.[2]

− Exogenous Melatonin.[2]

− Helps restore circadian rhythm.[2]

click to open accordion Where is Melatonin used?

Melatonin is used in circadian rhythm-related sleep disorders, which involve either difficulty in falling asleep, waking up during the sleep cycle, or waking up too early and being unable to fall back to sleep.[23]

click to open accordion Who should not be recommended Melatonin supplement?

Melatonin supplement may be avoided by:

• Pregnant and lactating women.[1]

• People with auto-immune disorders.[1]

• People with seizure disorders (e.g. epilepsy).[1,18]

click to open accordion How is Melatonin safer than other sleep medications used to treat sleep disorders, such as onset of insomnia?
  • Melatonin supplement[19]

1. Nonaddictive, nonhabit-forming supplement

2. Sleep improvement and multiple other health benefits

3. No adverse effects on long-term consumption

 

Other sleep medications[20,21]

Below are some significant adverse effects of long-term consumption:

a. Orexin receptor antagonists: Nausea and abnormal dreams

b. Antihistamine drugs: Sleepiness, dizziness, difficulty concentrating, and dry mouth

c. Antipsychotics: Metabolic syndrome and extrapyramidal symptoms

d. Benzodiazepines: Withdrawal side effects, drug dependence, psychomotor and cognitive side effects

e. Zolpidem: Memory lapses, hallucinations, paradoxical excitement

click to open accordion What are the consequences of improper regulation of circadian rhythm/sleep-wake cycle/sleep deprivation?

• Leads to depression[4]

• Shift work disorder[4]

• Poor immunity[4]

• Poor treatment outcomes in co-morbid conditions[5]

click to open accordion By what mechanism does Melatonin supplements help to regulate circadian rhythm or sleep cycle in the body in people with sleep disorders, such as onset or primary insomnia?

1. Melatonin levels increase in the bloodstream with increasing darkness.[2]

2. This natural Melatonin secretion is impaired due to environmental factors, such as school and work, and other factors, such as aging or comorbid conditions.[2,6]

3. Melatonin supplements can restore the decreased levels of Melatonin and help to restore the circadian rhythm.[2]

Note: Melatonin supplements can help to achieve better sleep if the patient has disrupted circadian rhythm. However, there is a lack of strong evidence that suggests the role of Melatonin supplementation in treating chronic insomnia.[7]

click to open accordion What is the half-life of Melatonin?

The half-life of Melatonin is only about 30–50 minutes.[8]

click to open accordion Can Melatonin usage cause symptoms of withdrawal or dependence (addiction)?

No. A study of 2 mg PR Melatonin discontinuation even after 12 months was not associated with adverse events, withdrawal symptoms, or suppression of Endogenous Melatonin Production.[9]

click to open accordion What is the recommended dosage of Melatonin?

Indian Psychiatric Society recommends 3 mg of Melatonin dosage as a Chronobiotic* agent.10 *Chronobiotics are agents that have the ability to shift the endogenous circadian phase.[11]

click to open accordion Is Melatonin safe for pregnant and lactating women?

Melatonin is not advisable for pregnant and lactating women.[12]

click to open accordion Does Melatonin cause any allergic reaction?

Melatonin does not contain any potential allergic agents, such as gluten, milk, eggs, soy, peanuts, or fish. Hence, it is hypoallergenic.[13]

However, in rare cases, it can cause severe allergic symptoms such as:[13]

• Skin rash and itching

• Depressed mood

• Confusion

click to open accordion What are the side effects of Melatonin overdose?

Prolonged ingestion of Melatonin, 1 g per day showed increased drowsiness but through studies on the eyes, liver, kidneys, and bone marrow, no other evidence of toxicity was revealed[14]

click to open accordion Can Melatonin supplement be prescribed to patients with type 2 diabetes mellitus (T2DM)?

It can be given to patients with Diabetes but keep the gap of 2 hours between food and Melatonin.[15]

click to open accordion Are there any drugs and foods/beverages that interact with Melatonin and cause adverse effects?

Drug interactions[16]

Melatonin prescription should be avoided with the following drug classes due to the adverse effects resulting from the drug interactions:

• Diazepam

• Anticoagulants and antiplatelet drugs

• Anticonvulsants

• Immunosuppressants

• Fluvoxamine

 

Food/beverage interactions

Consumption of alcohol with Melatonin might reduce the effect of Melatonin.[17]