Akay Bioactives trial finds ThymoDream comparable to melatonin in sleep support

A small randomized human clinical trial has found that Akay Bioactives’ ThymoDream ingredient improved key sleep parameters and demonstrated comparable outcomes to melatonin in select measures. Participants using the patented black cumin seed oil also had lower daytime sleepiness scores after seven days compared with melatonin use. 

The randomized, double-blind, active-controlled crossover study included 24 healthy volunteers with self-reported sleep disturbances. The researchers compared the efficacy and safety of ThymoDream at 200 mg per night to 5 mg of melatonin per night. 

“Melatonin may be widely used, but it’s not suitable for everyone,” says Frederik Krabbe Errebo, head of Business Unit at Akay Bioactives. 

“These findings show that ThymoDream offers a plant-based approach that works with the body’s natural processes while delivering measurable benefits for sleep, with select outcomes comparable to melatonin use, and with fewer reports of daytime sleepiness. For consumers seeking clean label solutions for sleep support, this represents a compelling option supported by clinical science.”

ThymoDream is a patented black cumin seed oil derived from Nigella sativa, which is standardized to deliver no less than 5% thymoquinone and 0.5% carvacrol in a 10:1 ratio. It is produced using cold-press technology to preserve high levels of bioactives without heat or solvents. 

Sleep duration and quality

Participants in the Frontiers in Sleep study wore activity-tracking devices to assess sleep duration and quality, and completed a validated assessment of daytime sleepiness on the Epworth Sleepiness Scale (ESS). The team notes that this provided a comprehensive evaluation of the ingredient’s effects compared to melatonin. 

During the study, participants wore a wristwatch to estimate sleep parameters such as sleep latency, total sleep duration, wake-after-sleep-onset, and sleep efficiency.All participants received each intervention for seven nights, separated by a seven-day washout period. The team assessed the quality of sleep and compared data on days one, three, and seven, corresponding to a single-dose, three-day, and seven-day supplementation. 

Researchers measured plasma melatonin, dim light melatonin onset, serum cortisol, actigraphy-based sleep parameters, and daytime sleepiness through ESS. 

People taking ThymoDream showed significant improvements in sleep efficiency, total sleep time, sleep latency, and wake after sleep onset over the study period. 

Alternative to melatonin

Outcomes of the activity trackers were comparable between the two interventions. Sleep latency and total sleep time improved more with melatonin, whereas ThymoDream significantly reduced cortisol levels and daytime sleepiness scores in a subgroup of nine participants.

In an adjusted between-treatment analysis, ThymoDream was associated with 12.6 minutes more total sleep on average, while melatonin was associated with 2.8 minutes shorter sleep latency.

Specifically, researchers note that melatonin supplementation induced a “rapid early rise in melatonin followed by a sharp decline,” while ThymoDream demonstrated a more sustained nocturnal profile.

Akay Bioactives notes that ThymoDream works from the first use and supports natural melatonin levels at a 2- to 2.9-fold increase for up to six hours. Moreover, the company says that ThymoDream influences circadian rhythm markers and helps people stay asleep longer.

Akay Bioactives notes that ThymoDream works from the first use and supports natural melatonin levels at a 2- to 2.9-fold increase for up to six hours.The company also underscores that ThymoDream lowers cortisol by 21.4% after seven days, while melatonin showed no significant change. The study authors say this effect on the stress hormone is “not generally observed for melatonin supplements.”

Of the 24 study participants, nine experienced significant daytime sleepiness at baseline. For this group, ThymoDream reduced daytime sleepiness scores by 25.7%, while melatonin reduced scores by 20.6%.

The researchers conclude: “Collectively, these findings suggest that ThymoDream may act as a natural alternative to conventional melatonin for improving sleep quality and circadian rhythm alignment.”

Stress and sleep support

Combined with earlier studies on stress, sleep, and immunity, Akay Bioactives notes that the new results support substantiated structure/function positioning for ThymoDream in formulations for sleep quality, stress resilience, and immune function. The company says the ingredient is well-suited for liquid-filled capsules and softgels. 

“These findings substantiate ThymoDream’s role in supporting sleep quality within a short timeframe, with reduced self-reported daytime sleepiness, positioning it as a promising option for individuals seeking support for occasional sleeplessness, including consumers who prefer to avoid melatonin,” states the company. 

Although melatonin remains the leading ingredient in sleep support, ingredient suppliers are highlighting that consumers increasingly prefer hormone-free alternatives such as botanical extracts. 

A five-year review of health records released in 2025 linked long-term use of melatonin to a higher risk of heart failure. However, US industry groups called for caution regarding these findings, noting that the ingredient is generally safe for short-term use and should not be used to treat chronic sleep conditions.