Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.

To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.

The following protocols were developed using only A through C-quality evidence.

Class
Qualifying studies
Minimum requirements
A
Systematic review or meta-analysis of human trials
 
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study

Sleep is essential for good health, yet it is reported that up to 30% of people experience difficulties with falling or staying asleep. (24) One study found the number of people suffering from various sleep disorders has also been on the rise. From the year 2013 to 2016, increases were seen in the prevalence of narcolepsy by 14%, idiopathic hypersomnia by 32%, periodic limb movement disorder by 30%, and rapid eye movement sleep behavior disorder by 64%. (2) 

Sleep disorders can occur as a secondary disease from other disorders or they can be considered the primary disease affecting a patient. A meta-analysis found that patients with anxiety, eating disorders, pervasive developmental, borderline, and antisocial disorders, and schizophrenia all experienced some sort of alteration to sleep. None of the conditions studied had similar polysomnographic profiles, suggesting each condition may have different underlying mechanisms. (6) 

Depending on the factors associated with disturbed sleep, a variety of therapies may be used. Interventions such as sedatives or anxiolytic pharmaceuticals are available; however, the American Academy of Sleep Medicine endorses the use of melatonin, light therapy, and behavioral interventions as the primary treatments. (4) 

The protocol presented below represents research findings to aid in achieving and maintaining good sleep.

Melatonin

2.5 to 3 mg, total per day (at bedtime), minimum three weeks (9)(20)

  • All patients with delayed sleep-wake phase disorder (DSWPD) received behavioral sleep-wake scheduling and then split into groups for a 0.5 mg dose of fast-release melatonin or placebo, melatonin decreased patient reported outcomes measurement information system (PROMIS) sleep disturbance, insomnia severity, functional disability, and sleep onset latency by 34 minutes compared to placebo; additionally 52.8% of patients in the treatment group had a more than minimal clinician-rated improvement compared to 24% of placebo, suggesting that while behavioral sleep-wake scheduling scheduling combining with melatonin is much more effective (22)
  • A meta-analysis of 12 studies found melatonin efficacious in delaying sleep phase syndrome, and decreasing sleep onset latency in primary insomnia; additionally melatonin was able to regulate sleep-wake patterns in blind patients (5) 
  • Pooled data from a meta-analysis and systematic review of 7 studies to be effective for management of secondary sleep disorders as demonstrated by the ability of melatonin to lower sleep onset latency and increase total sleep time (14) 
  • Patients with insomnia improved quality of sleep, as well as night before and morning alertness when given 2 mg of prolonged-release melatonin compared to placebo (12)
Melatonin in the Fullscript catalog

Valerian (Valeriana officinalis)

1060 mg, total per day, minimum 4 weeks (23)

  • Postmenopausal women demonstrated improved quality of sleep in 30% of the intervention group compared to 4% in the palcebo (23)
  • Primary insomnia patients previously treated with nightly benzodiazepines were given valerian or placebo for 15 days, treatment decreased wake time after sleep onset (WASO), increased sleep latency and alpha count in slow wave sleep, and improved subjective sleep quality after benzodiazepine withdrawal compared to placebo (19)
  • In a systematic review and meta-analysis, 6 studies found valerian to have significant benefits to improve sleep quality without side effects at a range of dosing (7)
  • Patients with psychophysiological insomnia demonstrated decreased slow wave sleep latency of 21.3 compared to 13.5 minutes in placebo; additionally, there was a low number of adverse effects compared to placebo (10)
Valerian in the Fullscript catalog

Lavender (Lavandula angustifolia)

80 mg Silexan™ daily for a minimum of 10 weeks (21) or diffused at bedtime (13)(17) 

  • A systematic review of 11 randomized controlled trials found that inhaled lavender essential oil had a positive effect on sleep for people with mild sleep disturbances (15)
  • When given Silexan™ once daily for 10 weeks, sleep and anxiety improved as shown by a decrease in total scores for hamilton anxiety scale (HAM-A) and Pittsburgh sleep quality index (PSQI), demonstrating the anxiolytic action of Silexan™ rather than sedative (21)
  • Patients with insomnia who diffused lavender before bedtime experienced decreased PSQI by 2.5 points compared to an almond oil control group; notably a more pronounced improvement in women and younger volunteers with milder insomnia (13)
  • Patients hospitalized in the ICU experienced increased overall sleep score (48.25 in treatment group, 40.10 in control) and experienced a significantly lower blood pressure between 12 am and 4 am compared to control when 3 mL of pure lavender oil was provided at bedside from 10 pm to 6 am (17)
  • 55 μl of lavender essential oil patch placed on the chest at night was effective for improving sleep quality and increasing feelings of refreshment upon awakening in college students with self-reported sleep problems (16)
Lavender in the Fullscript catalog

Chamomile (Matricaria chamomilla)

200 mg twice per day for a minimum of 28 days (3) or as a tea for a minimum of 2 weeks (8)

  • Sleep quality improved when elderly people aged 60 or older in day care nursing homes were given 200 mg twice per day compared to control (3)
  • Postnatal women with poor sleep quality improved physical symptoms related to sleep inefficiency and symptoms of depression when given chamomile tea for 2 weeks compared to control (8)
  • A systematic review and meta-analysis of 12 randomized controlled trials found chamomile to be effective in improving sleep quality and generalized anxiety disorder (11)
Chamomile in the Fullscript catalog

Magnesium

320 mg, total per day of magnesium citrate, minimum 7 weeks

  • Improved Pittsburg sleep quality index (PSQI) score, which includes improvements in sleep quality, sleep onset latency, sleep duration, sleep disturbance, daytime dysfunction, and hypnotic drug scores in adults with poor sleep quality; additionally participants who had a baseline value more than 3.0 mg/L of CRP experienced a decrease (18)
  • In addition to decreasing insomnia severity index (ISI) score, sleep onset latency and serum cortisol concentration, magnesium reduced early morning awakenings in elderly participants (1)
Magnesium in the Fullscript catalog

Disclaimer

The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.

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References
  1. Abbasi, B., Kimiagar, M., Sadeghniiat, K., Shirazi, M. M., Hedayati, M., & Rashidkhani, B. (2012). The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial. Journal of Research in Medical Sciences: The Official Journal of Isfahan University of Medical Sciences, 17(12), 1161–1169. https://pubmed.ncbi.nlm.nih.gov/23853635/ (C)
  2. Acquavella, J., Mehra, R., Bron, M., -H. Suomi, J. M., & Hess, G. P. (2020). Prevalence of narcolepsy and other sleep disorders and frequency of diagnostic tests from 2013–2016 in insured patients actively seeking care. Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine. https://jcsm.aasm.org/doi/abs/10.5664/jcsm.8482 (D)
  3. Adib-Hajbaghery, M., & Mousavi, S. N. (2017). The effects of chamomile extract on sleep quality among elderly people: A clinical trial. Complementary Therapies in Medicine, 35, 109–114. https://pubmed.ncbi.nlm.nih.gov/29154054/ (C)
  4. Auger, R. R., Burgess, H. J., Emens, J. S., Deriy, L. V., Thomas, S. M., & Sharkey, K. M. (2015). Clinical Practice Guideline for the Treatment of Intrinsic Circadian Rhythm Sleep-Wake Disorders: Advanced Sleep-Wake Phase Disorder (ASWPD), Delayed Sleep-Wake Phase Disorder (DSWPD), Non-24-Hour Sleep-Wake Rhythm Disorder (N24SWD), and Irregular Sleep-Wake Rhythm Disorder (ISWRD). An Update for 2015: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine, 11(10), 1199–1236. https://pubmed.ncbi.nlm.nih.gov/26414986/ (A)
  5. Auld, F., Maschauer, E. L., Morrison, I., Skene, D. J., & Riha, R. L. (2017). Evidence for the efficacy of melatonin in the treatment of primary adult sleep disorders. Sleep Medicine Reviews, 34, 10–22. https://pubmed.ncbi.nlm.nih.gov/28648359/ (A)
  6. Baglioni, C., Nanovska, S., Regen, W., Spiegelhalder, K., Feige, B., Nissen, C., Reynolds, C. F., & Riemann, D. (2016). Sleep and mental disorders: A meta-analysis of polysomnographic research. Psychological Bulletin, 142(9), 969–990. https://pubmed.ncbi.nlm.nih.gov/27416139/ (A)
  7. Bent, S., Padula, A., Moore, D., Patterson, M., & Mehling, W. (2006). Valerian for sleep: a systematic review and meta-analysis. The American Journal of Medicine, 119(12), 1005–1012. https://pubmed.ncbi.nlm.nih.gov/17145239/ (A)
  8. Chang, S.-M., & Chen, C.-H. (2016). Effects of an intervention with drinking chamomile tea on sleep quality and depression in sleep disturbed postnatal women: a randomized controlled trial. Journal of Advanced Nursing, 72(2), 306–315. https://pubmed.ncbi.nlm.nih.gov/26483209/ (C)
  9. Chen, W. Y., Giobbie-Hurder, A., Gantman, K., Savoie, J., Scheib, R., Parker, L. M., & Schernhammer, E. S. (2014). A randomized, placebo-controlled trial of melatonin on breast cancer survivors: impact on sleep, mood, and hot flashes. Breast Cancer Research and Treatment, 145(2), 381–388. https://pubmed.ncbi.nlm.nih.gov/24718775/ (B)
  10. Donath, F., Quispe, S., Diefenbach, K., Maurer, A., Fietze, I., & Roots, I. (2000). Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry, 33(2), 47–53. https://pubmed.ncbi.nlm.nih.gov/10761819/ (C)
  11. Hieu, T. H., Dibas, M., Surya Dila, K. A., Sherif, N. A., Hashmi, M. U., Mahmoud, M., Trang, N. T. T., Abdullah, L., Nghia, T. L. B., Y, M. N., Hirayama, K., & Huy, N. T. (2019). Therapeutic efficacy and safety of chamomile for state anxiety, generalized anxiety disorder, insomnia, and sleep quality: A systematic review and meta-analysis of randomized trials and quasi-randomized trials. Phytotherapy Research: PTR, 33(6), 1604–1615. https://pubmed.ncbi.nlm.nih.gov/31006899/ (A)
  12. Lemoine, P., Nir, T., Laudon, M., & Zisapel, N. (2007). Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. Journal of Sleep Research, 16(4), 372–380. https://pubmed.ncbi.nlm.nih.gov/18036082/ (B)
  13. Lewith, G. T., Godfrey, A. D., & Prescott, P. (2005). A single-blinded, randomized pilot study evaluating the aroma of Lavandula augustifolia as a treatment for mild insomnia. Journal of Alternative and Complementary Medicine , 11(4), 631–637. https://pubmed.ncbi.nlm.nih.gov/16131287/ (C)
  14. Li, T., Jiang, S., Han, M., Yang, Z., Lv, J., Deng, C., Reiter, R. J., & Yang, Y. (2019). Exogenous melatonin as a treatment for secondary sleep disorders: A systematic review and meta-analysis. Frontiers in Neuroendocrinology, 52, 22–28. https://pubmed.ncbi.nlm.nih.gov/29908879/ (A)
  15. Lillehei, A. S., & Halcon, L. L. (2014). A systematic review of the effect of inhaled essential oils on sleep. Journal of Alternative and Complementary Medicine , 20(6), 441–451. https://pubmed.ncbi.nlm.nih.gov/24720812/ (A)
  16. Lillehei, A. S., Halcón, L. L., Savik, K., & Reis, R. (2015). Effect of Inhaled Lavender and Sleep Hygiene on Self-Reported Sleep Issues: A Randomized Controlled Trial. Journal of Alternative and Complementary Medicine , 21(7), 430–438. https://pubmed.ncbi.nlm.nih.gov/26133206/ (C)
  17. Lytle, J., Mwatha, C., & Davis, K. K. (2014). Effect of lavender aromatherapy on vital signs and perceived quality of sleep in the intermediate care unit: a pilot study. American Journal of Critical Care: An Official Publication, American Association of Critical-Care Nurses, 23(1), 24–29. https://pubmed.ncbi.nlm.nih.gov/24382614/ (C)
  18. Nielsen, F. H., Johnson, L. K., & Zeng, H. (2010). Magnesium supplementation improves indicators of low magnesium status and inflammatory stress in adults older than 51 years with poor quality sleep. Magnesium Research: Official Organ of the International Society for the Development of Research on Magnesium, 23(4), 158–168. https://pubmed.ncbi.nlm.nih.gov/21199787/ (C)
  19. Poyares, D. R., Guilleminault, C., Ohayon, M. M., & Tufik, S. (2002). Can valerian improve the sleep of insomniacs after benzodiazepine withdrawal? Progress in Neuro-Psychopharmacology & Biological Psychiatry, 26(3), 539–545. https://pubmed.ncbi.nlm.nih.gov/11999905/ (C)
  20. Scheer, F. A. J. L., Morris, C. J., Garcia, J. I., Smales, C., Kelly, E. E., Marks, J., Malhotra, A., & Shea, S. A. (2012). Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers: a randomized controlled trial. Sleep, 35(10), 1395–1402. https://pubmed.ncbi.nlm.nih.gov/23024438/ (C)
  21. Seifritz, E., Schläfke, S., & Holsboer-Trachsler, E. (2019). Beneficial effects of Silexan on sleep are mediated by its anxiolytic effect. Journal of Psychiatric Research, 115, 69–74. https://pubmed.ncbi.nlm.nih.gov/31121394/ (B)
  22. Sletten, T. L., Magee, M., Murray, J. M., Gordon, C. J., Lovato, N., Kennaway, D. J., Gwini, S. M., Bartlett, D. J., Lockley, S. W., Lack, L. C., Grunstein, R. R., Rajaratnam, S. M. W., & Delayed Sleep on Melatonin (DelSoM) Study Group. (2018). Efficacy of melatonin with behavioural sleep-wake scheduling for delayed sleep-wake phase disorder: A double-blind, randomised clinical trial. PLoS Medicine, 15(6), e1002587. https://pubmed.ncbi.nlm.nih.gov/29912983/ (B)
  23. Taavoni, S., Ekbatani, N., Kashaniyan, M., & Haghani, H. (2011). Effect of valerian on sleep quality in postmenopausal women: a randomized placebo-controlled clinical trial. Menopause , 18(9), 951–955. https://pubmed.ncbi.nlm.nih.gov/21775910/ (B)
  24. Yazdi, Z., Sadeghniiat-Haghighi, K., Loukzadeh, Z., Elmizadeh, K., & Abbasi, M. (2014). Prevalence of Sleep Disorders and Their Impacts on Occupational Performance: A Comparison between Shift Workers and Nonshift Workers. Sleep Disorders, 2014, 870320. https://pubmed.ncbi.nlm.nih.gov/24977041/ (D)