Physician Indication & Safety Information

Recommend Defined Sleep with Confidence

FDA-registered Phase II Clinical Trial
Clinical trial results showed participants with severe insomnia experienced increased deep and REM sleep and decreased light sleep after taking Defined Sleep. Objective data was captured and reported by WHOOP, a wrist-worn sleep-tracking device. Subjectively, the majority of study participants reported an improvement in their sleep quality and duration.
Key Efficacy Data
Defined Sleep increased deep and REM sleep (restorative sleep) up to 1-hour per night during a 1-month period in individuals with insomnia. This has major health implications because restorative sleep supports the immune system, learning, memory, attention, cognition, and cell and tissue regeneration.

Clinical Trial Results*

Recently published in the Journal of Clinical Sleep Medicine
Restorative Sleep
Increased Shift Worker Efficacy

Increased Shift Worker deep and REM sleep. Our groundbreaking clinical sleep trial showed that shift workers had the best response to Defined Sleep’s formula, enjoying higher rates of deep and REM sleep. Only a good night’s sleep can combat what’s known as “sleep debt”, a deficit in the Deep and REM sleep phases which are crucial for human well-being.

Safety

  • No adverse events were reported in the clinical trial.
  • Non-sedating.
  • No effects on heart rate or heart rate variability.
  • No risk for dependency.
  • Contains no THC, is non-psychoactive and non-intoxicating. Will not cause fall risk for elderly. Safe option for those required to undergo workplace drug testing.


Contraindicated Drugs
Defined Sleep is safe to use on a daily basis for the vast majority of patients. However, it should not be taken by women who are pregnant. Additionally, a small number of prescription medications are contraindicated with CBD, and therefore it is important to check what medicines your patients are taking before recommending Defined Sleep. To determine if any prescription drugs your patients are taking are contraindicated with CBD, please check: https://www.webmd.com/interaction-checker/default.htm.


Moreover, we recommend that patients do not take Defined Sleep if they are taking any of the following drugs: clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, ritonavir, cyclosporine, rifampin, theophylline, tizanidine, lamotrigine, morphine, lorazepam, diazepam, clobazam, stiripentol, valproate, everolimus, sirolimus or tacrolimus.


Dosing

The recommended dose is to take 300 mg (two gel caps) one hour before going to bed. Higher doses (up to 600 mg) are well tolerated and may be more effective for some patients who suffer from extreme insomnia.

Defined Sleep: Key Differentiators from Over-the-counter (OTC) Sleep Aids and Prescription Sleep Medicines

The table below illustrates how Defined Sleep has a unique safety and efficacy profile in comparison to the most commonly sold and prescribed sleep aids and medicines.
Prescription Drug

or OTC Sleep Aid

Mechanism of

Action

Sedative
Effects on Deep and REM Sleep
Risk of Dependency and Misuse
Untoward Adverse Effects
Defined Sleep
OTC Sleep Aid
Multiple
No

Increases1

No
No
Diphenhydramine (Benadryl; ZzzQuil)
OTC Sleep Aid

Anti-histamine

Yes

Decreases2

No
Yes

Doxylamine (Unisom)

OTC Sleep Aid

Anti-histamine

Yes

No Effect3

No
Yes
OTC Sleep Aid

Melatonin

Receptor

Agonist

Yes

May Decrease4

No
Yes
OTC Sleep Aid

GABA

Receptor- Agonist

Yes

Not Determined

Yes
Yes
OTC Sleep Aid

GABA

Receptor- Agonist

Yes

Not Determined

Yes
Yes

Zolpidem

(Ambien)

Drug

GABA 

Receptor-Benzodiazepene Agonist

Yes

Decreases4

Yes
Yes

Eszopiclone (Lunesta)

Drug

GABA 

Receptor-Benzodiazepene Agonist

Yes

No Effect5

Yes
Yes

Zaleplon

(Sonata)

Drug

GABA 

Receptor-Benzodiazepene Agonist

Yes

Decreases6

Yes
Yes

Temazepam (Restoril)

Drug

Benzodiazepene

Yes

Decreases4,7

Yes
Yes

Doxepin (Silenor)

Drug

Anti-depressant

Yes

Decreases8

Yes
Yes

Ramelteon (Rozerem)

Drug

Melatonin

Receptor Agonist

Yes

Decreases9

Yes
Yes
Drug

Anti-depressant

Yes

Decreases10

Yes
Yes

Wholesale and Affiliate Opportunities

If you would like more information regarding Defined Sleep or would like to talk to us about Wholesale and Affiliate opportunites email us at info@definedsleep.com