Pure Sleep

Benefits & Features

• Helps your patients fall asleep, stay asleep, and wake up refreshed without morning grogginess‡
• Improves sleep quality, efficiency and duration with continued use‡
• Helps relieve occasional stress and anxiety‡
• Supports a healthy cortisol response‡
• Melatonin free
• Clinically studied ashwagandha (KSM-66)
• Clinically studied saffron (affron®)
• Clinically studied valerian root (Sleeproot)

Pure Sleep combines three clinically studied botanical extracts to help patients fall asleep, stay asleep and experience the restorative, restful sleep they need without morning grogginess. KSM-66 ® ashwagandha (Withania somnifera) root extract is a calming adaptogen that helps relieve occasional stress and anxiety and supports a healthy cortisol response.1, 2 Results from several randomized, placebo-controlled trials indicate that KSM-66 ® supports sleep onset, helping individuals fall asleep faster, while enhancing sleep quality and efficiency when taken continuously over several weeks.2-4 In a randomized, double blind clinical trial involving 80 adults, ashwagandha supplementation (KSM-66 ®, 300 mg twice daily) for 8 weeks led to a significant mean reduction in sleep onset latency (the time it takes to fall asleep after going to bed), sleep quality, and total sleep time.3 A 12- week randomized, double blind clinical trial demonstrated that ashwagandha (KSM-66 ®, 300 mg twice daily) improved subjective sleep parameters and mental alertness on rising, in healthy elderly subjects.4 Results from multiple clinical trials demonstrate that saffron extract (affron ®) promotes multiple aspects of restful sleep, supporting sleep onset and duration with continued use.5-7 In a randomized, double blind clinical trial involving 66 adults, saffron (affron ®, 15.5 mg per day) for 6 weeks led to significant improvements in ease of getting to sleep, sleep quality, sleep duration, and global Pittsburgh Sleep Quality Index (PSQI) scores.5 In a randomized double-blind, placebo controlled trial involving 63 healthy adults aged 18-70 with self-reported sleep concerns, saffron (affron ®, 14 mg twice daily) for 28 days led to greater improvements in Restorative Sleep Questionnaire (RSQ) total scores and the Pittsburgh Sleep Diary (PSD) sleep quality ratings compared to placebo.6 This formula also provides Sleeproot, a valerian root extract standardized to a higher potency (2% total valerenic acids) than typical extracts, that promotes sleep quality, efficiency and duration. In a randomized, double blind clinical trial involving 72 adults, Sleeproot (200 mg/day) for 8 weeks improved overall sleep quality, reduced sleep latency, enhanced sleep efficiency, and prolonged total sleep time. Sleeproot resulted in significant improvements in mean total PSQI sleep scores and reduced sleep latency, assessed by wrist actigraphy, compared to placebo.8*

References

1. Salve J, et al. Cureus 2019 Dec 25;11(12):e6466.
2. Langade D, et al. Cureus 2019; 11(9): e5797.
3. Langade D, et al. J Ethnopharmacol. 2021; 264: 113276.
4. Kelgane SB, et al. Cureus 2020; 12(2): e7083.
5. Pachikian BD, et al. Nutrients 2021 Apr 27;13(5):1473.
6. Lopresti AL, et al. J Clin Sleep Med. 2020 Jun 15;16(6):937-947.
7. Lopresti AL, et al. Sleep Med. 2021 Oct;86:7-18.
8. Shekhar CH, et al. Adv Ther. 2024 Jan;41(1):246-261.

*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.