Drug interactions & safety
Defined Sleep is safe on a daily basis for the vast majority of patients. A small number of prescription medications are contraindicated with CBD — check what your patients are taking before recommending.
Safety profile
- No adverse events reported in the clinical trial (medical monitor tracked throughout)
- Non-sedating; no effect on heart rate or heart rate variability
- No THC — non-psychoactive, non-intoxicating; no fall-risk concern for elderly patients; appropriate for patients subject to workplace drug testing
- No risk profile for dependency observed
Contraindications
Defined Sleep should not be taken by women who are pregnant.
We recommend patients do not take Defined Sleep if they are taking any of the following:
clarithromycin · itraconazole · ketoconazole · posaconazole · voriconazole · ritonavir · cyclosporine · rifampin · theophylline · tizanidine · lamotrigine · morphine · lorazepam · diazepam · clobazam · stiripentol · valproate · everolimus · sirolimus · tacrolimus
For any other medication, check the drug interaction checker or contact our medical team via Medical Inquiries.
Drug-by-drug comparison: effects on deep and REM sleep
How Defined Sleep's profile compares with commonly used sleep aids and prescription sleep medicines, with references by agent. (References as currently published on definedsleep.com/pages/physician-information; links to be re-verified in the citation audit before production.)
| 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 |
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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.