Global Pharmaceutical Research Case Report ISSN: 2632-2757 Infant sleep and the use of common remedies: A case report Lamya Alnaim1* and Yousif A. Shamsaldeen2 1Clinical Associate Professor, Clinical pharmacy Department, College of pharmacy, King Saud University, Saudi Arabia 2School of Physiology, Pharmacology & Neuroscience, Faculty of Biomedical Sciences, University of Bristol, Saudi Arabia Abstract Background: The rate and variety of use of common therapies to treat illness in different countries are quite different. Moreover, use of these therapies in infants and children is even more obscure. Unfortunately, these therapies are unstudied and unregulated. Little is known about the efficacy and more importantly the safety of such products. In this report we present the case of an infant who was supplemented with a product called Sleep Drops® which is marketed to be safe and effective. Case report: this is a case of a 6-month healthy infant who has trouble sleeping. Her mother gave her Sleep Drops® product at an increasing about for a couple of nights. the infant to be more agitated than usual during the day and her sleep pattern became more erratic and became drowsy at times and fell asleep faster at the beginning of the night. The mother sought advice from the community pharmacist because she is not happy with outcome of sleep drops and seeking other treatment for her infant to help her sleeping. Conclusion: Further analysis as to the content of the product reveals that it contains pharmacologically active substances that might cause serious side effects. In the future more, studies are needed to determine safety profile of these remedies. Presently, stricter regulations and more awareness are needed to protect the public from inappropriate use and possible dangerous consequences.beginning of the night. The mother sought advice from the community pharmacist because she is not happy with outcome of sleep drops and seeking other treatment for her infant to help her sleeping. Conclusion: Further analysis as to the content of the product reveals that it contains pharmacologically active substances that might cause serious side effects. In the future more, studies are needed to determine safety profile of these remedies. Presently, stricter regulations and more awareness are needed to protect the public from inappropriate use and possible dangerous consequences. Introduction found that sleeping the recommended hours regularly is associated with better health outcomes including improved attention, behavior, Newborn children do not have a developed circadian musicality learning, memory, emotional regulation, quality of life, and mental and and subsequently rest over different interims for the duration of the day physical health. Regular lack of enough sleep during early childhood and night in short sessions, which may also be due to infants’ feeding is linked to attention, behavior, and learning problems. Inadequate needs. The circadian rhythm starts developing at the age of 10-12 weeks, sleep also increases the risk of accidents, injuries, hypertension, obesity, when an infant starts to be able to sleep through the night. Through the diabetes, and depression. Insufficient sleep in teenagers is associated first year, the need for day sleep decreases while night sleep duration with increased risk of self-harm, suicidal thoughts, and suicide attempts increases [1]. [3]. Despite the general trend of decrease in Day time sleeping period, The rate and variety of using common therapies to treat illness in night awakenings show the highest levels of variability, The National different countries are quite different. (Fesharakinia & Abedini 2014) Sleep Foundation (NSF) recommends a daily sleep duration of 14- Despite relatively little is known about why people seek common sleep 17 hours/day from birth to 3 months, 12–15 hours/day from 4 to 11 remedies before conventional medical treatment, the use of common months, 11-14 hours/ day for infants aged 1-2 years, and 10-13 hours/ sleep remedies may be attributed to personal preference or choice and day for preschoolers aged 3–5 years [2]. beliefs about the health benefits of these remedies [4]. Individual’s Variation in infant sleep play has an important role in cognitive personal characteristics age, education, perceived control over health development and physical growth. Studies on cognition show that individual differences in sleep quantity and quality are particularly important for the development of memory, language, and executive *Correspondence to: Lamya Alnaim, Clinical Associate Professor, Clinical functions. Studies on physical growth indicate the potential risk of pharmacy Department, College of pharmacy, King Saud University, Saudi sleep problems, in particular shorter sleep duration early in life, for Arabia, Email: [email protected] overweight, obesity, or measures of adiposity in infants, toddlers, and Key words: sleeps drops®, complementary therapy, sleep, infants, common preschool-age children [1]. remedies, hypnotics, benzodiazepines, opioid The Consensus Statement of the American Academy of Sleep Received: February 26, 2019; Accepted: March 12, 2019; Published: March 14, Medicine (CSACSM) summarized key evidence related to the panel 2019 Global Pharm Res, 2019 doi: 10.15761/GPR.1000106 Volume 5: 1-4 Alnaim L (2019) Infant sleep and the use of common remedies: A case report and spirituality significantly predicted intention to try common sleep because the recommended dose of one drop was not effective. The remedies [5,6]. mother noticed her infant to be more agitated than usual during the day and her sleep pattern became more erratic although the infant seemed An increasing number of parents are using complementary drowsy at times and fell asleep faster at the beginning of the night. The therapies to induce sleeping to their children. There is still insufficient mother sought advice from the community pharmacist because she is data to determine the safety profile of these therapies, nonetheless, not happy with outcome of sleep drops and seeking other treatment mothers believe that these therapies are natural and thus safe [7]. for her infant to help her sleeping. The mother admits she obtained the Parents of new-borns and infants suffer from lack of sleep due to the product through a seller she found on social media. The pharmacist erratic sleep patterns of their youngsters. This lack of sleep leads to researched about this product and the ingredients in it. She advised the fatigue in the parents and in turn causes them to seek different solutions mother to stop using it since it contains some ingredients that might be including quick fixes such as over the counter antihistamines or cough unsafe for the infant and advised the mother to visit her pediatrician. syrups. Some parents resort to alternative or herbal therapies due to the false belief that these “natural” products are safer. Examples include The mother visited the pharmacist again later the same day, to melatonin, chamomile, lemon balm, and commercial products such as report that the infant was examined and is well and healthy. It has been Sleep Drops®, Bioray Inc., NDF Sleep®. more than 24 hours since the last dose and there seems to be no residual effect of the sleep Drops®. The pharmacist spent time with the mother Sleep Drops® is marketed through Sleep drops International and is to educate her against buying products from unknown sources and the sold though many commercial websites [8-10]. Different products are dangerous of using such products especially in infants. available for adults, kids and infants’ babies. The company claims that the products are aimed to target toddlers from 0-3 years and 3-12 years Discussion of age and claim to produce the following benefits [11]: At the clinic, examinations failed to find any health issues with the • Supports for your babies or toddlers getting to sleep and staying infant that could explain the restless sleep pattern except the infant asleep! being in the early teething stage. The mother and infant were referred • Support for a calm and happy baby due to additional support for to the nurse to educate the mother on strategies to use to help with common complaints such as teething or colic, that can cause your infant sleep problems and complications of teething. Additionally, the little one to be unhappy mother was referred to the pharmacist to go over what remedies and non-prescription medication that can or cannot be used safely for this • Support for “tummy” issues infant. • More sleep for you as a parent When analyzing the suggested method of administration, the Sleep • Total confidence, knowing you are giving your infant a natural Drops® product states that “drops are to be put under the tongue, or formula close to the tongue and lips, inside the mouth” [15]. This indicates that the route of administration is not through ingestion, but it is through • More “me time” for you, as you spend less time calming a distressed sublingual or buccal administration, which is considered as a major little one route of administration that by-passes the first pass hepatic metabolism The products list the following ingredients: [16]. Therefore, this route of administration has a direct access to the bloodstream and hence rapid onset of action. Moreover, since the “Organic Coconut Glycerine, purified water, ethanol, Corydalis concentration of ingredients is unknown and hence their bioavailability, ambigua (Corydalis), Eschscholzia californica (Californian poppy), the response