The only CBD sleep formulation with peer-reviewed clinical evidence of increased deep and REM sleep
FDA-registered, double-blind, placebo-controlled, randomized crossover Phase 2 trial — published in the Journal of Clinical Sleep Medicine.
Read the Clinical Study Register for Practice Resources
Drug-by-drug comparison: effects on deep and REM sleep
How Defined Sleep compares with commonly used sleep aids and prescription sleep medicines, with references by agent. Interaction guidance is on the Drug Interactions & Safety page.
| Agent | Class | Mechanism | Sedative | Effect on deep & REM sleep | Dependency risk | Adverse effects |
|---|---|---|---|---|---|---|
| Defined Sleep | OTC supplement | Multiple (CBD + terpenes) | No | Increases [ref] | No | None in trial |
| Diphenhydramine (Benadryl, ZzzQuil) | OTC | Antihistamine | Yes | Decreases [ref] | No | Yes |
| Doxylamine (Unisom) | OTC | Antihistamine | Yes | No effect [ref] | No | Yes |
| Melatonin | OTC | Melatonin receptor agonist | Yes | May decrease [ref] | No | Yes |
| GABA (oral) | OTC | GABA receptor agonist | Yes | Not determined | Yes | Yes |
| Magnesium | OTC | GABA receptor agonist | Yes | Not determined | Yes | Yes |
| Zolpidem (Ambien) | Rx | GABA-A / benzodiazepine-site agonist | Yes | Decreases [ref] | Yes | Yes |
| Eszopiclone (Lunesta) | Rx | GABA-A / benzodiazepine-site agonist | Yes | No effect [ref] | Yes | Yes |
| Zaleplon (Sonata) | Rx | GABA-A / benzodiazepine-site agonist | Yes | Decreases [ref] | Yes | Yes |
| Temazepam (Restoril) | Rx | Benzodiazepine | Yes | Decreases [ref] [ref] | Yes | Yes |
| Doxepin (Silenor) | Rx | Antidepressant | Yes | Decreases [ref] | Yes | Yes |
| Ramelteon (Rozerem) | Rx | Melatonin receptor agonist | Yes | Decreases [ref] | Yes | Yes |
| Trazodone | Rx | Antidepressant | Yes | Decreases [ref] | Yes | Yes |
Start here
The Evidence
Trial design, endpoints, objective measurement, results, and limitations — written for a clinical reader.
The clinical study →Read the published study →
Clinical Use
Indications and patient selection, dosing, drug interactions, and combining Defined Sleep with CBT-I.
Indications →Your Practice
Practice ordering and practice discount codes for your patients.
Register for practice resources →Developed by a neuroscientist. Validated in a clinical trial.
Defined Sleep was created by Paul Muchowski, Ph.D. — former Professor at the University of Washington and UCSF, neuroscience drug discovery scientist (Teva Pharmaceuticals, Soteria Therapeutics), and author of more than 60 highly cited research studies.
- Increased deep and REM sleep — up to 2X in the low-baseline responder subgroup
- Non-sedating; no effect on heart rate or heart rate variability
- No adverse events reported in the clinical trial
- 300 mg pharmaceutical-grade CBD (99.9% pure isolate) + eight plant-based terpenes
- No THC · No melatonin · Third-party tested every batch
Trusted by physicians
Our medical advisors use and recommend Defined Sleep in their own practices.
“Insomnia is a common symptom associated with many psychiatric conditions, including anxiety. I recommend Defined Sleep to my psychiatry patients because it is a safe and effective alternative to stronger sleep medicines.”
“I recommend Defined Sleep to my patients with insomnia because it is highly effective, backed by a clinical trial, and safer than most OTC sleep aids.”
“I recommend Defined Sleep to post-menopausal patients; it is highly beneficial.”
Guidance by practice area
Sleep Neurology
Architecture-level evidence for sleep neurologists and sleep medicine practices, including hypnotic-averse patients.
Explore →Psychiatry
A non-sedating option for psychiatric patients with insomnia where sedative burden is a concern.
Explore →Menopause — Family Practice & OB/GYN
A non-hormonal, melatonin-free option for sleep disruption in perimenopause and beyond.
Explore →Family & General Practice
Evidence-backed guidance for the most common sleep complaints in primary care.
Explore →Sports Medicine
Deep sleep is when recovery happens. THC-free matters for tested athletes.
Explore →Bring clinically validated restorative sleep to your patients
Register in under a minute for patient literature, practice ordering, and practice discount codes.
Register as an HCP Ask our science & medical teamPublished study (JCSM) · ClinicalTrials.gov NCT05233761 · Ask our science & medical team
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.