The Kurdistan Region’s Ministry of Health has introduced comprehensive regulatory guidelines for the use of melatonin supplements, emphasizing strict protocols for pediatric use and tighter controls on distribution.

In a directive issued on Friday, the Ministry detailed new measures targeting melatonin gummies and other related products. These regulations include age-restricted usage protocols and stringent pharmaceutical distribution requirements aimed at safeguarding public health.

Key Safety Measures

The guidelines specify several critical safety protocols:

Children under 2 years: Melatonin use is strictly prohibited.

Individuals under 18 years: Medical consultation is mandatory before use.

Children under 12 years: Melatonin is contraindicated if used simultaneously with compounds containing Passiflora.

To ensure safety and quality, the Ministry has mandated that all melatonin-containing products be distributed only through approved pharmaceutical channels. Distribution will require official certification from the Ministry and validation by the Quality Control Department.

Clinical Administration Guidelines

The directive also outlines best practices for melatonin use:

Optimal timing: 20 to 60 minutes before sleep onset.

Post-meal interval: A minimum of two hours.

Dosing: Emphasis on minimal effective doses to prevent overuse.

Particular attention has been given to potential interactions with medications affecting the central nervous system (CNS). The Ministry advises professional medical consultation for individuals using melatonin alongside CNS-affecting drugs.

Broader Context

The regulatory measures come in response to growing international concerns over the widespread and unregulated use of melatonin, especially among children. The Ministry’s new framework aligns with global pharmaceutical safety protocols while addressing specific challenges within the Kurdistan Region’s healthcare system.

The directive has been circulated to all provincial health directorates and autonomous administrations in the Kurdistan Region, ensuring that the guidelines are implemented uniformly across the region.

These steps mark a significant move toward improving public health and ensuring the safe use of supplements, particularly for vulnerable populations like children.