Sleep Support Protocol: A Resource For Practitioners


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by Fullscript’s Integrative Medical Advisory Team

With approximately 30%-40% of adults reporting problems falling and/or staying asleep, sleep issues are one of the most common complaints among adults globally. (4) The prevalence of insomnia in the general population is approximately 10 to 15%, with an increased prevalence in women, older adults, and those with certain chronic health conditions. (17) It is estimated that 40% of adults with insomnia have relied on medication or alcohol to promote sleep. (4) Despite these significant statistics, insomnia is still believed to be under-diagnosed and under-treated. (17)

What is insomnia?

Insomnia is a common sleep disorder characterized by difficulty falling asleep and/or staying asleep. (12)(17) The condition can be acute or chronic. In cases of acute insomnia, sleep issues only last a few days or weeks and are often triggered by stress or a traumatic event. In cases of chronic insomnia, sleep issues may persist for a period of one month or longer. Chronic insomnia is often a result of other sleep disorders or medical conditions, certain medications, or substance use. Insomnia as a symptom or side effect of another issue is referred to as secondary insomnia. The exact cause of primary insomnia, which is a distinct disorder, has not been fully established, however, chronic stress or emotional upset may be involved. (12)

woman in bed holding her head

Insomnia is a common sleep disorder characterized by difficulty falling asleep and/or staying asleep.

Causes and risk factors

Several risk factors have been associated with insomnia, including:

  • Gender (more common in women)
  • Age (more common in older adults)
  • Onset of menses and menopause
  • Nightime or shift work (12)(16)
  • Psychosocial stress (e.g., divorce, death of a loved one)
  • Alcohol or substance abuse (9)(12)
  • Lower income
  • Frequent travel and time changes
  • Physical inactivity
  • Caffeine intake
  • Certain medications (e.g., theophylline, beta-blockers, some allergy and cold medications) (12)
  • Certain personality traits (e.g., ambitiousness, perfectionism, low extraversion, neuroticism, low extraversion, susceptibility to depression and worry)
  • Developmental issues during childhood (e.g., separation anxiety)
  • Immobility (9)

Secondary insomnia may present as a symptom of certain preexisting medical conditions, including:

  • Periodic limb movement disorder (PLMD)
  • Hypoxemia and dyspnea (16)
  • Restless legs syndrome (RLS)
  • Sleep-related breathing disorders (e.g., snoring, dyspnea, sleep apnea)
  • Psychiatric disorders (e.g., depression, anxiety, PTSD)
  • Gastroesophageal reflux disease (GERD) (9)(12)(16)
  • Pain conditions (e.g., arthritis, headache disorders)
  • Neurodegenerative diseases (e.g., Alzheimer’s disease, Parkinson’s disease) (12)(16)
  • Stroke
  • Hyperthyroidism (12)

Signs, symptoms, and complications

The International Classification of Sleep Disorders (ICSD-3) characterizes insomnia as difficulty falling asleep, difficulty staying asleep, or poor quality sleep despite adequate opportunity, resulting in daytime dysfunction. (9)

Insomnia can significantly impact daily function and quality of life. A number of side-effects are associated with impaired sleep, such as:

  • Daytime sleepiness/drowsiness (9)(12)
  • Difficulty learning, remembering, and/or focusing on tasks (12)
  • Mood changes (e.g., feelings of irritability, anxiety, depression) (9)(12)(16)
  • Impaired academic and/or work performance and productivity
  • Increased risk of motor vehicle accidents (9)(16)

While anxiety, depression, and other psychiatric disorders may lead to secondary insomnia, it has been noted that individuals with primary insomnia also have a significantly higher risk of developing a subsequent psychiatric condition. (16)

man sleeping in his bed

Research demonstrates that supplementation with melatonin, magnesium, and valerian root may also be effective in improving sleep.

Integrative protocol for sleep support

Insomnia is commonly addressed using behavioral therapy (e.g., sleep hygiene, relaxation therapy, cognitive behavioral therapy) (9) and pharmaceutical medications (e.g., antihistamines, chloral hydrate, barbiturates, and benzodiazepines). (4)(16) Research also demonstrates that supplementation with melatonin, magnesium, and valerian root may also be effective in improving sleep.

Melatonin

Melatonin is a neurohormone produced by the pineal gland (5) that plays an important role in the regulation of sleep and circadian rhythms. (22) Production and release of melatonin varies throughout the day, rising in the evening to promote sleep and falling again in the morning to promote wakefulness. (11) Production of melatonin also decreases with age, increasing the risk of sleep disorders in older adults. (22)

Melatonin supplementation has become one of the more widely used non-prescription sleep aids. (7) Research has shown that melatonin is effective in addressing insomnia and sleep disorders, including jet lag, shift work-related sleep issues, and delayed sleep phase syndrome. (7)(11) While melatonin is most well-known for its effects on sleep, research has begun examining its potential therapeutic use in other health conditions, such as cancer, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS). (11)

Research findings:

  • Increase in sleep quality was observed without adverse effects (6)(18)
  • During the withdrawal period of melatonin, carryover of the effect on sleep latency time was observed on the following night (18)
  • Improvement in sleep onset latency, sleep-wake patterns, and delayed sleep phase syndrome (2)
  • The lowest dosing of exogenous melatonin is recommended in order to mimic the natural physiological circadian rhythm of melatonin (22)

US: Search for Melatonin in the Fullscript catalog.
CAN: Search for Melatonin in the Fullscript catalog.

Valerian (Valeriana officinalis)

Native to Europe and Asia, Valeriana officinalis is a perennial flowering plant of the Valerianaceae family. (4)(13) Extracts from its roots have been used for decades to improve sleep and reduce restlessness, tremors, and anxiety in Europe. In the United States, valerian has been naturalized and its use for insomnia and sleep difficulties is becoming increasingly popular. According to a 2002 national survey, it was reported that approximately two million adults in the U.S. had used valerian in the past week. (4) The effects of valerian are believed to be attributed to its primary active components, including essential oils, valepotriates, valerenic acid, valenol, and alkaloids. (3)

Research findings:

  • Improvement in sleep quality and overall effectiveness observed in clinical insomnia (4)(21)
  • Reduction in sleep onset latency was observed in a concentrated extract of a 5.3:1 ratio (10)

US: Search for Valeriana officinalis in the Fullscript catalog.
CAN: Search for Valeriana officinalis in the Fullscript catalog.

valerian root extract on a wooden spoon

The use of valerian root for insomnia and sleep difficulties is becoming increasingly popular in the U.S.

Magnesium

Following calcium, sodium, and potassium, magnesium is the fourth most abundant mineral in the human body. (1)(8)(19)(20) It is involved in over 300 enzymatic reactions and plays an essential role in many body functions, particularly those related to neurotransmitter synthesis and energy (ATP) metabolism. (1) Dietary sources of magnesium can be found in both plant and animal foods. Some of the highest sources of magnesium include green leafy vegetables (e.g., spinach, kale), nuts, seeds, legumes, and whole grains. (14)

Unfortunately, magnesium deficiency is becoming increasingly prevalent in western countries, (8) which may be in part attributed to a shift away from a diet abundant in fresh vegetables and whole grains to an increased consumption of processed and refined foods. (1) Magnesium deficiency can result in cardiac and neurological manifestations and has been associated with several chronic health conditions, including osteoporosis, hypertension, coronary heart disease, and diabetes. (20)

While the exact mechanism by which magnesium affects and regulates sleep has yet to be determined, it is believed that magnesium promotes relaxation and facilitates sleep as it is a natural N-methyl-D-aspartate (NMDA) antagonist and a GABA agonist. (1)(19)

Research findings:

  • Improvement of PSQI score, which includes improvements in sleep quality, sleep onset latency, sleep duration, sleep disturbance, daytime dysfunction, and hypnotic drug scores (15)
  • In addition to improving PSQI score, magnesium reduced early morning awakenings (1)

US: Search for Magnesium in the Fullscript catalog.
CAN: Search for Magnesium in the Fullscript catalog.

Key takeaways

Insomnia is a common condition among adults that can significantly impact daily function and quality of life. Research has shown that supplementation with melatonin, magnesium, and valerian root may be effective in improving sleep onset latency, duration, and quality. A protocol using natural supplements can be used therapeutically on its own or as an adjunct to existing treatment. If you are not an integrative healthcare provider, we recommend speaking with one to learn whether these supplements are ideal for your wellness plan.

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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.

  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, 17(12), 1161-1169.
  2. 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.
  3. Barton, D. L., Atherton, P. J., Bauer, B. A., Moore, D. F., Jr, Mattar, B. I., Lavasseur, B. I., … Loprinzi, C. L. (2011). The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: A phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5). The Journal of Supportive Oncology, 9(1), 24-31.
  4. 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.
  5. Buscemi, N., Vandermeer, B., Pandya, R., Hooton, N., Tjosvold, L., Hartling, L., … Klassen, T. (2004). Melatonin for treatment of sleep disorders: Summary. In Agency for Healthcare Research and Quality (US), AHRQ Evidence Report Summaries. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK11941/
  6. 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.
  7. Costello, R. B., Lentino, C. V., Boyd, C. C., O’Connell, M. L., Crawford, C. C., Sprengel, M. L., & Deuster, P. A. (2014). The effectiveness of melatonin for promoting healthy sleep: A rapid evidence assessment of the literature. Nutrition Journal, 13, 106.
  8. Han, H., Fang, X., Wei, X., Liu, Y., Jin, Z., Chen, Q., … Cao, Y. (2017). Dose-response relationship between dietary magnesium intake, serum magnesium concentration and risk of hypertension: A systematic review and meta-analysis of prospective cohort studies. Nutrition Journal, 16(1), 26.
  9. Kaur, H., & Bollu, P.C. (2011). Chronic insomnia. In S. Rao Bolla, B. Abai, A. Abu-Ghosh, A.B. Acharya, U. Acharya, S.G. Adhia, … H. Zulfiqar (Eds). StatPearls. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK526136/
  10. Koetter, U., Schrader, E., Käufeler, R., & Brattström, A. (2007). A randomized, double blind, placebo-controlled, prospective clinical study to demonstrate clinical efficacy of a fixed valerian hops extract combination (Ze 91019) in patients suffering from non-organic sleep disorder. Phytotherapy Research, 21(9), 847-51.
  11. National Center for Complementary and Integrative Health. (2015). Melatonin: In depth. Retrieved from https://nccih.nih.gov/health/melatonin
  12. National Heart, Lung, and Blood Institute. (n.d.). Insomnia. Retrieved from https://www.nhlbi.nih.gov/health-topics/insomnia
  13. National Institutes of Health. (2013). Valerian. Retrieved from https://ods.od.nih.gov/factsheets/Valerian-HealthProfessional/
  14. National Institutes of Health. (2019). Magnesium. Retrieved from https://ods.od.nih.gov/factsheets/Magnesium-HealthProfessional/
  15. 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, 23(4), 158-68.
  16. Roth, T. (2007). Insomnia: Definition, prevalence, etiology, and consequences. Journal of Clinical Sleep Medicine, 3(5 Suppl), S7-S10.
  17. Saddichha, S. (2010). Diagnosis and treatment of chronic insomnia. Annals of Indian Academy of Neurology, 13(2), 94-102.
  18. Scheer, F.A.J.L., Morris, C.J., Garcia, J.I., Smales, C., Kelly, E.E., Marks, J., … 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.
  19. Schwalfenberg, G. K., & Genuis, S. J. (2017). The importance of magnesium in clinical healthcare. Scientifica, 2017, 4179326.
  20. Swaminathan R. (2003). Magnesium metabolism and its disorders. The Clinical Biochemist Reviews, 24(2), 47-66.
  21. 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), 951-5.
  22. Vural, E.M., van Munster, B.C., & de Rooij, S.E. (2014). Optimal dosages for melatonin supplementation therapy in older adults: A systematic review of current literature. Drugs & Aging, 31(6), 441-51.