Sleep Medicine For Children: Safety, Side Effects, Dosage And Precautions

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Sleep deprivation and insomnia can disrupt the physical and psychological development of your child. The treatment for pediatric insomnia (sleeplessness) usually starts with behavioral strategies. Sleep medications are often used as adjunct therapy and are prescribed off-label (used in a manner not specified in the FDA’s approved packaging label).

Children should take sleep medicines only on prescription by a doctor and after proper screening for the underlying cause. Over-the-counter (OTC) products should be avoided. Read this post to know about sleep medicines for kids, their safe use, and their side effects.

Are Sleep Medicines For Children Safe?

The American Academy of Sleep Medicine (AASM) discourages the use of sleep medications in children as the ones available are meant for use in adults. They are not recommended by authorities, such as the US Food and Drug Association (FDA), for pediatric use. Thus, they are prescribed off-label by pediatricians if required.

OTC sleep medications should not be used without consulting a doctor. The prescriber needs to adjust its dose according to your child’s body weight to avoid overdose (1)(2).

What Sleep Medicines Are Used In Children?

Sleep medicines are sometimes required for sleep problems due to neurodevelopmental disorders (NDDs). The following categories of medications may be prescribed based on screening and clinical experience of the physician (3).

  1. Iron (in various salt forms): Iron plays a role in the sleep-wake cycle and improves oxygen supply to the body cells via hemoglobin. It may improve sleep disturbances in children with autism and be used as an adjunct. However, more research is required to obtain sufficient evidence.
  1. Antihistamines: Medications such as diphenhydramine (Nytol, Sominex, Benadryl) can inhibit receptors for the neurotransmitter histamine (H1 receptors) in the brain and cause sleepiness. These are usually prescribed for a short duration to aid sleep.
  1. Melatonin: Melatonin is a hormone produced in the body that regulates the circadian cycle (day and night or sleep-wake cycles). Melatonin as a sleep medicine for children is most described in the medical literature. It is becoming a popular choice among clinicians, especially for sleep initiation but not for maintaining it (4).
  1. Ramelteon: It acts as a melatonin receptor agonist (enhances melatonin function). It is FDA-approved to treat adult insomnia, but insufficient data is available to prove its efficacy in children.
  1. Clonidine: It is an alpha 2 adrenergic agonist that works on presynaptic neurons in the brain to decrease noradrenaline activity. It has sedative effects that may help in initiating and maintaining sleep and is often used in children who have associated behavioral symptoms.
  1. Gabapentin: Gamma-aminobutyric acid (GABA) is an inhibitory neurotransmitter in the brain where GABAA receptors favor sleep. Gabapentin increases GABA concentration and assists sleep. It is not much prescribed due to the lack of adequate studies in children. However, children taking this medication for any other condition may show improved sleep as a secondary benefit (5).
  1. Clonazepam: It belongs to the benzodiazepine class of drugs that act via GABAA receptors to induce sleep. It may be beneficial in children with Williams syndrome who often show movement arousal disorder. Clonazepam may improve nighttime awakenings, but its use should be short-term to avoid habituation.
  1. Non-benzodiazepine sedative-hypnotics: Medications such as zolpidem, zaleplon, eszopiclone act by modulating GABA action to produce sleep. Their use has been studied in children with sleep disturbances and ADHD, where they did not improve sleep significantly. Although effective in adults, these drugs are seldom recommended in children due to lack of efficacy and risk of adverse effects.
  1. Trazodone: It is a sedative-antidepressant drug with an effect on multiple neurotransmitters. Trazodone is clinically used to manage pediatric insomnia but supporting data for efficacy is insufficient. Some studies report benefits in children and adolescents with depression and insomnia (6).

What Are The Side Effects Of Sleep Medicines In Children?

The most common side effect of sleep medicines is persistent drowsiness. Other drug-wise adverse effects are as follows (3)(7).

  • Antihistamines: Dizziness, confusion, restlessness, dry mouth, difficulty urinating, and constipation
  • Melatonin: Seizures, stomach problems, and agitation
  • Benzodiazepines: Amnesia (forgetfulness), vertigo, muscle weakness (unstable or shaky movements), aggression, and irritability
  • Non-benzodiazepine sedatives: Bitter or metallic taste, nausea, diarrhea, dizziness, headache, hallucinations, nightmares, and sleepwalking, which may cause serious accidents (8)
  • Clonidine: Fatigue, headache, dry mouth, constipation, and complications in children with existing heart disorders (9)
  • Gabapentin: Nighttime awakenings
  • Trazodone: Heart arrhythmias, low blood pressure (hypotension), and priapism (painful and persistent penile erection) in adolescent males
  • Iron supplements: Does not cause drowsiness but may cause constipation, diarrhea, stomach pain, nausea, and teeth staining (10)

What Are The Alternatives To Sleeping Pills For Children?

Behavioral therapy is first suggested to improve sleep quality in children. Medicines are usually added only if behavioral therapy is inadequate or does not yield any results.

Parents may also try other interventions at home that could help improve the child’s sleep behaviors. For instance, you must implement a bedtime routine and good sleep hygiene for your child. Limiting screen time is important to reduce exposure to blue light emitted from the screens of devices such as television, computers, smartphones, and tablets. Blue light could interfere with the healthy sleep-wake cycle by affecting melatonin release in the body.

Below are some other measures to maintain sleep hygiene (11).

  • Set a regular bedtime
  • Keep the bedroom dark, quiet, and conducive to sleeping
  • Avoid giving caffeinated beverages after 3:00 pm
  • Ensure a fixed wake-up time in the morning

What Are The Precautions Needed When Using Sleep Medications For Children?

Sleep medications for children should be used with caution, such as those mentioned below (7).

  • Long-term use of most of these medications (especially benzodiazepine and non-benzodiazepine sedatives) may cause dependence. Therefore, there should be short-term use unless suggested by a doctor.
  • Sleep medications may cause tolerance on repeated use (loss of efficacy). Treatment duration with one agent should usually not exceed four weeks.
  • Cough and cold medications may contain drugs that sedate the brain. Do not use them without consulting a doctor when your child is on sleep medications.
  • Tell your healthcare provider about your child’s sleep medications whenever he/she needs any other medication.
  • Keep all sleep medications out of children’s reach in child-proof containers. Accidental overdose can be fatal for young children.

Children require a personalized treatment plan comprising behavioral therapy with or without medications to cope with sleep difficulties. Medicines are not encouraged for pediatric insomnia, but if necessary, they should be given only if the doctor prescribes them. Herbal remedies, such as chamomile, have limited evidence to prove efficacy. Make sure to look out for signs of adverse effects if your child has been prescribed sleeping pills and avoid missing scheduled follow-ups with the doctor.


MomJunction's articles are written after analyzing the research works of expert authors and institutions. Our references consist of resources established by authorities in their respective fields. You can learn more about the authenticity of the information we present in our editorial policy.
  1. Avoid sleeping pills for children with insomnia.
  2. Barbara T. Felt and Ronald D. Chervin, Medications for sleep disturbances in children.
  3. Allison Beck Blackmer and James A. Feinstein, Management of Sleep Disorders in Children With Neurodevelopmental Disorders: A Review.
  4. Irvin Janjua and Ran D. Goldman, Sleep-related melatonin use in healthy children.
  5. Althea A Robinson and Beth A Malow, Gabapentin shows promise in treating refractory insomnia in children.
  6. Addo Boafo et al., Medications for sleep disturbance in children and adolescents with depression: a survey of Canadian child and adolescent psychiatrists.
  7. Oral Sleeping Medicines.
  8. FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines.
  9. Clonidine.
  10. Iron Supplements.
  11. Sleep problems in children.
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Dr. Joyani Das

Dr. Joyani Das is a PhD in Pharmacology with over two years of experience in academics. Previously, she worked as an associate professor, faculty of Pharmacology. With her research background in preclinical studies and a zeal for scientific writing, she joined MomJunction as a health writer. Her research work was published in international journals and publications, such as Elsevier, Current... more