Non
Addictive
Deeper
Sleep
DESCRIPTION
Melatonin is a naturally occurring sleep-inducing
hormone produced by the pineal gland and is structurally
related to serotonin. Physiologically, melatonin secretion
increases soon after the onset of darkness peaks at 2-4
hours, and diminishes during the second half of the
night.
Vitamin B6 supports sleep by helping to boost the
production of melatonin itself.
Regulate Sleep
Wake Cycle
Regulate Sleep
Wake Cycle
Day Light
Melatonin
Inhibit
Dark
Stimulate
Shift Work
Alcohol
Caffeine Jet lag or
Time Change
Blue Light
Age
Indications
Melatonin reduces the time it
takes to fall asleep, Melatonin
might be more beneficial for older
adults who could be melatonin
deficient.
Primary Insomnia
Indications
Melatonin improve jet lag
symptoms, such as alertness and
daytime sleepiness.
Jet Lag
Indications
In this disorder, your sleep pattern
is delayed two hours or more from
a conventional sleep pattern,
causing you to go to sleep later
and wake up later. Research
shows that melatonin reduces the
length of time needed to fall
asleep and advances the start of
sleep in adults and children with
this condition.
Delayed Sleep
Phase
Indications
Melatonin can improve daytime
sleep quality and duration in
people whose jobs require them to
work outside the traditional
morning to evening schedule.
Shift work
disorder
Indications
Melatonin helps treat sleep
disturbances in children with a
number of disabilities. However,
good bedtime habits are usually
recommended as an initial
treatment.
Sleep
disorders in
children
WARNINGS AND PRECAUTIONS
Melatonin may cause drowsiness; therefore, the
product should be used with caution if the effects of
drowsiness are likely to be associated with a risk to
safety.
Melatonin is not recommended for use in patients with
autoimmune diseases.
Melatonin should not be used in hepatic impairment
due to CYP P450 enzyme.
INTERACTIONS
• Cytochrome P450 isoenzymes and CYP1A2 are involved in the metabolism of melatonin
and consequently other drugs that inhibit or induce these isoenzymes may affect melatonin
levels.
• Melatonin should not be taken with fluvoxamine, methoxsalen, cimetidine, or estrogens, all
of which increase the melatonin concentrations through inhibition of its metabolism.
• Tobacco smoking may decrease melatonin levels due to the induction of CYP1A2.
Cigarette smoking may decrease melatonin levels due to induction of CYP1A2. CYP1A2
inducers such as carbamazepine and rifampicin may give rise to reduced plasma
concentrations of melatonin.
• Alcohol should not be taken with melatonin, because it reduces the effectiveness of
melatonin on sleep. Melatonin may enhance the sedative properties of benzodiazepines and
non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone.
USE IN SPECIFIC POPULATIONS
Hepatic impairment
There are markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in
patients with hepatic impairment. Therefore, Melatonin is not recommended for use in patients with hepatic
impairment.
Pregnancy
According to the Sleep Foundation, research suggests that supplemental melatonin is safe during pregnancy when
used under medical supervision.
Nursing Mothers
The breast-feeding is not recommended in women under treatment with melatonin.
Pediatric Use
Melatonin is beneficial for some children who have difficulty falling asleep, when the supplement is accompanied
by a behavioral program to address the sleep problems..
Renal impairment
Caution should be used when melatonin is administered to renal patients
OVERDOSAGE
Somnolence was the most reported adverse event.
Most were mild to moderate in severity. If overdose
occurs, drowsiness is to be expected. Clearance of
the active substance is expected within 12 hours
after ingestion. No special treatment is required.
Competitor MRP Analysis
Brand Name
Pack
Size
MRP
Company
Name
Melatonin 30'S 30'S 850 Nutrifactor
Melonia 20's 20'S 750 Genetics
Pause 20's 20'S 400 Cell Lab
Somno 30'S 30's 459.99 R2H (Highnoon)
850
750
400
459.99
0
100
200
300
400
500
600
700
800
900
Melatonin 30'S Melonia 20's Pause 20's Somno 30'S
Melatonin 3mg
Competitor Sales Analysis
54700
24000
11700
138600
0 20000 40000 60000 80000 100000 120000 140000 160000
DEVIS PHARMA
GENETICS
CELL LAB
R2H (HIGHNOON)
MELATONIN
MELONIA
20'S
PAUSE
20'S
SOMNO
30'S
Melatonin Sales (Packs) Analysis
Brand
Name
Pack
Size
Sales
(Packs)
Sales
(Value)
Company
Name
Melonia 20's 20'S
24,000
2642000 Genetics
Pause 20's 20'S
11,700
4170000 Cell Lab
Somno 30'S 30's
138,600
40696000
R2H
(Highnoon)
MELATONIN 30's
54,700
14793000
DEVIS
PHARMA
Total
229,000 62,301,000
PRESENTATION
Nyton available in
Blister Pack of 30 soft
gelatin capsules in
MRP RS 530.

NYTON Melatonin softgel capsules for sleep.pptx

  • 1.
  • 2.
    DESCRIPTION Melatonin is anaturally occurring sleep-inducing hormone produced by the pineal gland and is structurally related to serotonin. Physiologically, melatonin secretion increases soon after the onset of darkness peaks at 2-4 hours, and diminishes during the second half of the night. Vitamin B6 supports sleep by helping to boost the production of melatonin itself. Regulate Sleep Wake Cycle Regulate Sleep Wake Cycle
  • 4.
  • 5.
    Shift Work Alcohol Caffeine Jetlag or Time Change Blue Light Age
  • 7.
    Indications Melatonin reduces thetime it takes to fall asleep, Melatonin might be more beneficial for older adults who could be melatonin deficient. Primary Insomnia
  • 8.
    Indications Melatonin improve jetlag symptoms, such as alertness and daytime sleepiness. Jet Lag
  • 9.
    Indications In this disorder,your sleep pattern is delayed two hours or more from a conventional sleep pattern, causing you to go to sleep later and wake up later. Research shows that melatonin reduces the length of time needed to fall asleep and advances the start of sleep in adults and children with this condition. Delayed Sleep Phase
  • 10.
    Indications Melatonin can improvedaytime sleep quality and duration in people whose jobs require them to work outside the traditional morning to evening schedule. Shift work disorder
  • 11.
    Indications Melatonin helps treatsleep disturbances in children with a number of disabilities. However, good bedtime habits are usually recommended as an initial treatment. Sleep disorders in children
  • 14.
    WARNINGS AND PRECAUTIONS Melatoninmay cause drowsiness; therefore, the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. Melatonin is not recommended for use in patients with autoimmune diseases. Melatonin should not be used in hepatic impairment due to CYP P450 enzyme.
  • 16.
    INTERACTIONS • Cytochrome P450isoenzymes and CYP1A2 are involved in the metabolism of melatonin and consequently other drugs that inhibit or induce these isoenzymes may affect melatonin levels. • Melatonin should not be taken with fluvoxamine, methoxsalen, cimetidine, or estrogens, all of which increase the melatonin concentrations through inhibition of its metabolism. • Tobacco smoking may decrease melatonin levels due to the induction of CYP1A2. Cigarette smoking may decrease melatonin levels due to induction of CYP1A2. CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin. • Alcohol should not be taken with melatonin, because it reduces the effectiveness of melatonin on sleep. Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone.
  • 17.
    USE IN SPECIFICPOPULATIONS Hepatic impairment There are markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment. Therefore, Melatonin is not recommended for use in patients with hepatic impairment. Pregnancy According to the Sleep Foundation, research suggests that supplemental melatonin is safe during pregnancy when used under medical supervision. Nursing Mothers The breast-feeding is not recommended in women under treatment with melatonin. Pediatric Use Melatonin is beneficial for some children who have difficulty falling asleep, when the supplement is accompanied by a behavioral program to address the sleep problems.. Renal impairment Caution should be used when melatonin is administered to renal patients
  • 18.
    OVERDOSAGE Somnolence was themost reported adverse event. Most were mild to moderate in severity. If overdose occurs, drowsiness is to be expected. Clearance of the active substance is expected within 12 hours after ingestion. No special treatment is required.
  • 19.
    Competitor MRP Analysis BrandName Pack Size MRP Company Name Melatonin 30'S 30'S 850 Nutrifactor Melonia 20's 20'S 750 Genetics Pause 20's 20'S 400 Cell Lab Somno 30'S 30's 459.99 R2H (Highnoon) 850 750 400 459.99 0 100 200 300 400 500 600 700 800 900 Melatonin 30'S Melonia 20's Pause 20's Somno 30'S Melatonin 3mg
  • 20.
    Competitor Sales Analysis 54700 24000 11700 138600 020000 40000 60000 80000 100000 120000 140000 160000 DEVIS PHARMA GENETICS CELL LAB R2H (HIGHNOON) MELATONIN MELONIA 20'S PAUSE 20'S SOMNO 30'S Melatonin Sales (Packs) Analysis Brand Name Pack Size Sales (Packs) Sales (Value) Company Name Melonia 20's 20'S 24,000 2642000 Genetics Pause 20's 20'S 11,700 4170000 Cell Lab Somno 30'S 30's 138,600 40696000 R2H (Highnoon) MELATONIN 30's 54,700 14793000 DEVIS PHARMA Total 229,000 62,301,000
  • 21.
    PRESENTATION Nyton available in BlisterPack of 30 soft gelatin capsules in MRP RS 530.