The Woolcock Institute of Medical Research

Melatonin use has increased significantly in recent years with many turning to it as a natural and safe option for addressing sleep problems. In Australia, it is regulated by the Therapeutic Goods Administration, available on prescription for specific conditions and over-the-counter in 2mg melatonin prolonged release tablets for adults aged 55 and over who are experiencing short-term, primary insomnia.

It’s use, however, comes with side-effects the most common being carry-over sleepiness the next day which mean that weighing up its pros and cons can be a day-by-day proposition.

Is the promise of a better night’s sleep worth feeling tired the next day?

A team at the Woolcock Institute is working on a smarter solution: inhaled melatonin.

“Oral melatonin has to be taken two to three hours before bed,” says Dr Hui Xin Ong, research leader at the Woolcock’s Respiratory Technology group. “Absorption is slow and unpredictable, it varies depending on your age, gender, what you’ve eaten, and more. Higher doses can cause side effects like fatigue and confusion the next day.”

FASTER AND LOWER

The Respiratory Technology group’s focus is on improving treatment through the development of new drug formulations and delivery devices.

Dr Ong’s team is developing a melatonin inhaler that works faster and at a much lower dose.

“By delivering it directly to the lungs using a standard metered-dose inhaler, just like a Ventolin blue puffer, we can bypass the gut and the liver. The melatonin reaches the bloodstream in minutes. You could fall asleep within 30 minutes of two or three puffs.”

The team has completed formulation and device selection and, with support from the Woolcock’s Centre for Chronic Diseases of Ageing, they’re now launching an investigator-led clinical trial to compare the new inhaled method with traditional tablets. Fifteen volunteers will participate in a sleep study using high-resolution brain monitoring and blood tests to track how quickly the inhaled melatonin takes effect, and whether it avoids next-day grogginess.

SCIENCE-LED RESEARCH

Investigator-led trials differ from industry-led trials and government funded research in their funding and focus. They are driven by clinicians or researchers seeking to answer specific clinical questions and are “self-funded”. Because of that, they are able to pursue innovative research directions and, if successful, can lead to larger industry-sponsored trials.

“This is a proof-of-concept study to show that if we take inhaled melatonin, we can do so in lower doses and see faster absorption in the blood and improved efficacy in insomnia patients in terms of their sleep quality and the onset of sleep.”

“We know that with oral melatonin it builds slowly and leaves the body slowly. Our hypothesis is that when you inhale melatonin you can achieve a very quick spike that will hopefully correlate with the onset of sleep but you don’t have that residual melatonin in your system that causes grogginess the next day. That's what we're trying to establish with the trial.”

READY, SET ...

The team has completed formulation and device selection, and they’re now launching a clinical trial to compare the new inhaled method with traditional tablets. Fifteen volunteers will participate in a sleep study using high-resolution brain monitoring and blood tests to track how quickly the inhaled melatonin takes effect, and whether it avoids next-day grogginess.

“We believe inhaled melatonin can help people sleep better, faster, and wake up more refreshed,” says Dr Ong. “It’s an exciting step forward.”

The product is still in early testing stages, but it could offer a game-changing new option for insomnia, jet lag, and shift work sleep issues.

Find out more

• Our Respiratory Technology Research Group
• Sleep services at the Woolcock Clinic
• Insomnia Clinic