New insomnia pill passes first safety check in healthy volunteers

NCT ID NCT04667429

Completed Symptom relief Sponsor: Sunshine Lake Pharma Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called HEC83518 in 57 healthy Chinese adults to see if it is safe and how the body processes it. Participants took the drug or a placebo daily for 15 days. The study focused on side effects and drug levels in the blood, not on whether it improves sleep.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: HEC83518
What this could lead to: If successful, this could lead to a new sleep aid for people with insomnia.
What could go wrong: This is an early Phase 1 safety study in healthy people, not patients. It does not test if the drug actually helps with insomnia, and many early-stage drugs fail to show benefit later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

INSOMNIA

Contacts and locations

Locations

The Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.