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 Table of Contents  
Year : 2022  |  Volume : 14  |  Issue : 4  |  Page : 238-242

The phenomenon of giving hypnotic medications to children without a therapeutic purpose

1 Department of Clinical Pharmacy, Faculty of Pharmacy, University of Hail, Saudi Arabia
2 Student in, Faculty of Pharmacy University of Hail, Saudi Arabia

Date of Submission24-May-2022
Date of Decision05-Sep-2022
Date of Acceptance03-Nov-2022
Date of Web Publication16-Dec-2022

Correspondence Address:
Mhdia Elhadi Osman
Department of Clinical Pharmacy, Faculty of Pharmacy, University of Hail, P.O. Box 2440, Hail
Saudi Arabia
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ajprhc.ajprhc_53_22

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Background: The antihistamines such as chlorpheniramine malate, triprolidine, and pseudoephedrine cause sedation and are prescribed for insomnia as a first-line drug. Some mothers in Saudi Arabia reported using these medications for their children to induce and regulate sleep without prescription. This unnecessary and dangerous practice can cause serious side effects. Objective: The research aimed to discover the prevalence of sedative medication use among children in Saudi Arabia and evaluation of the mother's awareness of the seriousness of these medications' effects. This research also aimed to provide natural alternatives. Materials and Methods: A cross-sectional study has been conducted using a structured online questionnaire. The survey has been performed to identify the views of mothers on the subject and the reasons for their use of medicines and the most widely used drugs, dosage, and side effects. Fifty responses were collected from mothers and evaluated using Statistical Package for the Social Sciences (SPSS) software. Results: Most participants use sedative drugs to keep their children calm and in a deep sleep with ignorance and a lack of awareness of their serious side effects. We strongly encourage the initiation of awareness campaigns using pamphlets and other platforms including messages. Conclusion: Mothers, mainly working women, tend to use hypnotic medication for their children without a therapeutic indication. This practice needs to be stopped by awareness campaigns using both traditional and electronic formats.

Keywords: Children, Saudi Arabia, sedation medication

How to cite this article:
Osman ME, Khaloofi HA. The phenomenon of giving hypnotic medications to children without a therapeutic purpose. Asian J Pharm Res Health Care 2022;14:238-42

How to cite this URL:
Osman ME, Khaloofi HA. The phenomenon of giving hypnotic medications to children without a therapeutic purpose. Asian J Pharm Res Health Care [serial online] 2022 [cited 2023 Jun 8];14:238-42. Available from: http://www.ajprhc.com/text.asp?2022/14/4/238/363940

  Introduction Top

Sedatives are medications used to control anxiety and behavior, reduce physical discomfort and psychological trauma, and increase the potential for amnesia.[1] Furthermore, sedatives prevent nausea/vomiting after surgery and lower postoperative negative psychological effects, such as sleeping problems and negative behavioral changes.[2]

Self-medication and ready-to-use medications for infants, many of which are opiates, became popular in the late 19th century. Proprietary drugs, for example, became commonplace in Australian homes and were given to children nearly as soon as they grew restless or “cross” during the night.[3]

Because clinical trials generate a very little data on this issue throughout the clinical development of medications, monitoring the safety of medicine usage in children is critical. Off-label and offline use refers to the use of medications outside of the license's specifications, for example, in terms of formulation, indications, contraindications, or age and is a major source of worry.[4],[5]

The requirement for the sedation of a child is “no administration of sedating medication without the safety net of medical.”[1]

Over-the-counter hypnotics

Diphenhydramine and doxylamine, chlorpheniramine maleate and triprolidine-pseudoephedrine, triprolidine, and combination chlorpheniramine maleate/phenylephrine HCl are over-the-counter (OTC) antihistamine drugs that cause drowsiness; hence, some mothers use this medication for their children without therapeutically needs every week.[6]

OTC drugs for cough and cold are used by 10% of American children. Antihistamines, antitussives, expectorants, decongestants, and antipyretics are common ingredients in OTC cough/cold medication (OTC CCM) formulations. In the recent years, several published reports have linked OTC CCM ingredients, when used both correctly and incorrectly to morbidity and mortality.[7]

Mechanism of action of hypnotic medication

In general, hypnotic and sedative drugs increase the activity of gamma-aminobutyric acid (GABA), a neurotransmitter in the brain. Neurotransmitters are chemicals created and released by nerves that bind to receptors on other nerves and serve as a means of communication between nerves. Drowsiness is produced by increased GABA activity in the brain, which helps facilitate or maintain sleep.[8]

Dependence, over-the-counter hypnotics

OTC medication abuse is defined as the use of nonprescription medications for nonmedical purposes.[9] If used in excess amounts, OTC sleep aids can cause hallucinations, delirium, and confusion with recovery after withdrawal syndrome.[10]

Side effects

The main side effects of hypnotics depend on the type of hypnotic used, including headache, nausea, short-term memory loss, rebound insomnia, dry mouth, unpleasant taste, confusion, dependence, hallucinations, and dizziness.[11] The possible serious side effects may include dysuria and may cause urinary retention, increase in blood pressure, cognitive deficit, and psychomotor function in adults and children.[12] When administering cough or cold medicine to a child, always follow the guidelines on the medicine label. Do not give the drug to a child for the purpose of solely putting him or her to sleep. In very young children, the overuse of cough or cold drugs might result in death.[13] Other hypnotics like flu-care, sine up & Soolan, which are all antihistamines, and have sedative, activates.[14]

Hypnotic alternatives

Melatonin is a naturally occurring molecule biosynthesized by the pineal gland of vertebrates; it has also been identified in many plants. It is considered an important antioxidant and may retard the development of some neurodegenerative diseases and cancer. The serum melatonin concentration can increase after fruit consumption.[15] Some of the fruits that increase melatonin concentration are as follows:


Eating cherry or drinking juice can improve sleep quality, because cherry contains melatonin, a substance that helps regulate the sleep-wake cycle. Furthermore, cherries contain potassium and manganese, which enhance muscle relaxants.[16]


Honey contains potassium and manganese and increases melatonin in the body, so it can improve muscle relaxation and prompt sleep at night. Furthermore, a mixture of milk and honey provides relief from cough and improves sleep quality.[17]


German chamomile is widely used in babies and children as a mild sedative and to treat colic and teething pain; other herbs such as hops, passiflora, schisandra, and anise are used mainly as a sedative, anxiolytic, hypnotic, and tranquilizer.[18],[19]

Rationale of the study

The use of hypnotic medications for children is a near-widespread problem in some Saudi societies. This problem is due to the lack of thorough knowledge of the side effects of these medications. Some people believe that medications given without a prescription OTC have no side effects. This problem has caused the deterioration of the health of children.

  Materials and Methods Top

This is a cross-sectional randomized study that was conducted by an online structured questionnaire in the Hail region for mothers who have healthy children (aged 1–12 years) and use sedative medication without the need for therapeutics. The sample size was sufficient (50). The questionnaire contained demographic data of the mothers, type of medication use, dose, duration, whether the mother has observed any side effect, if yes, they have to mention the side effects and their reaction toward those side effects, and finally nonmedical alternative use. The Thomson and Reuters Citation Management Program Endnote version. 7 and the Statistical Package for the Social Sciences (SPSS) Version: (190); of (IBM company on New Orchard Road Armonk, New York United States) was used.

  Results Top

Demographic data

The characteristics of those who were relied on to fill out the questionnaire: Saudi mothers who use sleeping drugs for their children aged 1–12 years without the need for therapeutics. The majority of the mothers was in the age group of 31–45 years and occupied, and their children were male aged 1–3 years; mothers who least-used hypnotic drugs are mothers aged 46 or more and unoccupied, and the children were female aged 8–12 years [Table 1] P is significant ≤ 0.05.[20]
Table 1: Demographic data (n=50)

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Medication information

The most hypnotic medication used is chlorpheniramine maleate (44.0%), with a dosage of 2 mg (50.0%) 3 times per week (48%), for more than 3 years (42%), then followed by both chlorpheniramine maleate and triprolidine-pseudoephedrine (36.0%) with 4 and 1 mg dose (16%) 4–6 times a week (30.0%) for 1–2 years (39%). The minimum hypnotic used is triprolidine-pseudoephedrine (10%) at a dosage of 2–4 mg (10%) with another dose interval (8%) for <1 year (20%); 64% of children who consumed hypnotics developed side effects, 62.0% felt drowsiness and dizziness, while 4.0% had constipation and stomach upset; 34.0% had other side effects like vomiting, anorexia, weight loss, amnesia, and feeling nervous and angry. However, some mothers are not aware of the health changes in their children.

A total of 96% of mothers who participated in this study gave hypnotics to their children, and 4% of them developed tolerance [Table 2].
Table 2: Medication information (n=50)

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Mother's behavior when side effects occur

The study revealed that 32% of the mothers take their children to the doctor if there is a side effect, while 8% of the mothers take their children to a pharmacist.

Unfortunately, 60% of the mothers do not take their children to a doctor or pharmacist [Figure 1].
Figure 1: The frequency percentage of mothers' behavior toward side effects. P = 0.000 n = 50

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Using an alternative to hypnotics

A total of 86% of mothers do not use any other alternative drugs, because they have a lack of information about the alternative, whereas 14% of mothers use alternative drugs [Figure 2].
Figure 2: The frequency percentage of using an alternative to hypnotics. P = 0.000 n = 50

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Important relationship

Correlation between age and side effects

Children who experienced drowsiness and dizziness are more predominant in children aged 4–7 years than children aged 1–3 years, although the minimum in children aged 8 years and less common side effects are constipation and stomach upset [Figure 3].
Figure 3: The frequency percentage of correlation between age and side effects. n = 50

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  Discussion Top

More than half of the mothers, who are middle-aged and occupied, use hypnotic medication without the need for therapeutics, i.e., they are busy taking care of their children; this is contradicted by Shefrin (2009), who noted that only 10% of Americans use those medications in children who do not require therapeutics.[7]

This study revealed that nearly half of the children in Saudi Arabia using hypnotic medication without therapeutic purpose are males aged 4–7 years, which is similar to some extent to the study conducted by Hartz (2012), who cited that hypnotic drug use peaked at 15 per 1000 among children aged 1–2 years male. The levels of recurrent use (2007–2011) were 12% in boys and 8% in girls.[21]

Most mothers use chlorpheniramine maleate or both chlorpheniramine maleate and triprolidine-pseudoephedrine, but there are some mothers who give their children available hypnotics; this is supported by Peter Hauri (2013)[6] and Shefrin and Goldman (2009), who mentioned that a majority of these medications were used, but in other countries.[7]

Fifty percent of the mothers use a minimum effective dose of 2 mg; 16% of the mothers use higher doses of 4 mg, but 4% of these mothers increased the routine dose to get the same effects, and children might become tolerant to the dose already given. The following doses were recommended by Woo (2008): pseudoephedrine dose at 15 mg q/d for children aged 2–5 years, 30 mg q6h for children aged 6–12 years, and 15 mg q6 h and 60 mg qrd/day for children aged <12 years.[22] However, no literature has mentioned this tolerance.

Nearly half of the children are given hypnotic medication 3 times per week and then increased 4–6 times per week; there is overuse of hypnotic medication per week in children; this is contradicted by Woo (2008) who reported 4 times per day.[22]

A nearly equal number (40%) of mothers use hypnotics in children aged 3 or 1–2 years, while 20% of mothers use hypnotics for <1 year, i.e., the majority of mothers use the medication for more than 1 year. The literature review revealed that no relevant data were reported in pediatrics.

However, another study found that most of the elderly users (73%) had been taking hypnotic drugs for more than 1 year, with 25% reporting drug use for more than 10 years.[23]

Of the two-thirds of mothers who have observed changes in their children, only one-third interfered and sought medical advice mainly from doctors and rarely from pharmacists; mothers simplified hypnotics' side effects. No literature discusses this problem.

Drowsiness and dizziness are the major side effects of hypnotics medication, while constipation is less observed; furthermore, that side effect is more predominant in children aged 4–7 years than in children aged 1–3 years, although this is minimum in children aged more than 8 years; this is contradicted by a study in 2009[7] by Shiffrin and Goldman, who reported that the rate of adverse reactions was the highest in children aged below 2 years.[7]

  Conclusion Top

Mothers between the ages of 31–45 years are more vulnerable to using hypnotic medication for their children without a therapeutic indication. Chlorpheniramine maleate and triprolidine-pseudoephedrine are the preferred sedatives for children in Saudi Arabia. Some mothers pay no attention to the toxic side effects of these medicines, but are only concerned about the hypnotic effects. Such hypnotic medications have a huge negative impact on children. Some mothers prolong the administration of hypnotic drugs, because they are unable to tolerate their children's hyperactivity and crying. Sedative medication affects a majority of children, because low attention is being paid to the side effects of such drugs. Many mothers do not prefer alternative measures for sedating their children.


The authors would like to express their thanks to all the members in the Department of Clinical Pharmacy at the University of Hail, and many thanks to their colleague Dr. Weiam Abdulrahim Abdulqadir in the Department of Pharmaceutical Chemistry; College of Pharmacy, University of Hail, and all participants for their support.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

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  [Figure 1], [Figure 2], [Figure 3]

  [Table 1], [Table 2]


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