An Efficient As Well As Safe Dry Pinhalable Melatonin Device For Apid Sleep Aid

This product is a melatonin dry powder inhaler (DPI). The active ingredient is melatonin, derived from plant or animal secretion or synthesized entirely. The melatonin DPI also includes the following excipients: lactose monohydrate and magnesium stearate.

• Molecular Formula: C13H16N2O2
• Molecular Weight: 232.27
• CAS Number: 73-31-4   
• pKa: 12.3-12.7

Mechanism of Action:
Melatonin is a naturally occurring hormone produced by the pineal gland, structurally related to serotonin. Physiologically, melatonin secretion peaks rapidly after nightfall, reaching its zenith between 2-4 a.m. and diminishing in the late night. Melatonin is involved in the control of circadian rhythms and regulation of the day-night cycle. It is also associated with a sedative effect, increasing the tendency to sleep, and can be used for non-anxiety-related sleep disorders and jet lag adjustment.

Product Specifications:

200 micrograms per inhalation, 60 inhalations per canister, 1 canister per box.

Use 1-2 inhalations per dose.

Usage Guide:

This inhalation device is a multiple-dose inhaler. During use, the active ingredient is delivered to the lungs, so it is crucial to inhale with force and deep breaths through the mouthpiece. Before using this product, the device needs to be primed. The steps for priming are as follows:

1. Unscrew and remove the cap, ensuring the handle is in the downward position (see Figure1).
2. Hold the device straight, with one hand gripping the middle part of the device to secure it,and use the other hand to rotate the handle base to the left (see Figure 2), then rotate it back to the right (see Figure 3), producing a “click” sound during both rotations.
3. Repeat step 2 once. Priming is complete after steps 2 and 3.

After priming, please follow the instructions below:

1. 1. Unscrew and remove the cap, ensuring the handle is in the downward position (see Figure1).
   2. Hold the device straight, with one hand gripping the middle part of the device to secure it, and use the other hand to rotate the handle base to the left (see Figure 2), then rotate it back to the right (see Figure 3), producing a “click” sound during both rotations, indicating one dose dispensing.
   3. Exhale; do not exhale into the mouthpiece.
   4. Gently place the mouthpiece between the upper and lower teeth, completely covering it  with both lips, and inhale forcefully and deeply (see Figure 4).
   5. Remove the mouthpiece from the mouth, hold breath for about 5 seconds, then exhale.
   6. If multiple inhalations are required,   steps 2-5.
   7. Screw the cap tightly.

Precautions:
• Avoid exhaling into the mouthpiece.
• Securely screw the cap after each use.
• Do not disassemble any part of the device.
• Due to the small dose, you may not feel it with each inhalation. However, following the
above steps ensures the required dose is inhaled.
• Wipe the mouthpiece with a dry tissue regularly (at least once a week). Do not use water
or liquids to clean the external surface of the mouthpiece.
• Store the device in a dry environment after each use.
• This product is not recommended for use by pregnant and lactating women, and children.
Dose Indicator Window:
The dose indicator window indicates the remaining dose in the inhalation device. Every 20
inhalations have a numeric mark, and when the red mark reaches the middle of the indicator window,
the inhalation device will no longer deliver the correct dose. The inhalation device should be
discarded. The sound heard when shaking the inhalation device is not produced by the active
ingredient but by the desiccant.

Product Comparison with Similar Products:

 

Product	Melatonin DPI	Similar Electronic Heating Aerosol Products	Similar Oral Health Products
Dosage Form	DPI	Electronic Heating Aerosol Solution	Tablets, Capsules
Specification	200μg per inhalation	10μg per inhalation	1-5mg per tablet
Dosage per Use	1-2 inhalations per use	10 inhalations per use	1-2 tablets per use
Bioavailability	>85%	>85%	15%
Effective Deposition*	50-70%	Approximately 20%	—
Onset Time	Fast (≈5 minutes)	Slow (15-20 minutes)	Slow (>30 minutes)
Sedative Effect	Good	Moderate	Moderate
Side Effects	Minor	Moderate	Major
Stability	Long-term stability at room temperature	Unstable, prone to degradation	Long-term stability at room temperature

*Effective Deposition: The proportion of the active ingredient that can rapidly deposit in the lungs
for absorption.