The following discusses medications that may be helpful for short-term treatment of sleep problems, especially for children and youth with special health care needs (CYSHCN). Sleep hygiene interventions should always precede medication use and, if insufficiently effective, should continue as medications are tried. Due to lack of high-quality evidence, use of all of these medications for treatment of pediatric sleep disorders is “off-label.” Their use in children and the doses listed below are, for many, extrapolated from expert opinion and studies in a single population (such as iron supplementation for children with autism spectrum disorder) and many of the studies referenced are not of high quality. Ideally, sleep medications should be used for a limited time in pediatric patients as an adjunct to behavioral approaches; consider weaning off the medication in 2-3 months or sooner, whenever possible.

The Medical Home Portal provides this guide as a helpful resource, but it is the responsibility of the prescribing clinician to refer to the manufacturer website for specific information regarding dosing, monitoring, interactions, precautions, and contraindications.

Lack of high-quality evidence
Many pediatric sleep medications are used “off-label.” They have not been studied extensively in children and are associated with a number of concerning adverse effects and medication interactions.

Consult a pediatric sleep specialist
Strongly consider specialist consultation prior to initiating long-term sleep medications or high-risk/high-side effect medications like antipsychotics. Pediatric sleep specialists include specially trained pulmonologists and psychiatrists. For children with seizures and/or spasticity, a neurologist or physiatrist can also provide expert guidance. For sleep apnea, direct referral to ear, nose, and throat (ENT) services can be considered.

Anxiety-related sleep problems
Of the selective serotonin reuptake inhibitors (SSRIs), citalopram and fluvoxamine can cause mild sedation and, therefore, may be considered for treatment of anxiety-related sleep problems.

Insomnia and gastrointestinal problems
Children with insomnia and gastrointestinal problems may find treatment with gabapentin or amitriptyline can help both concerns.

Over-the-counter medications are often not reviewed and approved by the FDA, provided the manufacturers comply with general regulations.

Melatonin: A natural brain hormone involved in setting biologic rhythms. It is used to help with sleep onset and circadian rhythms. Evidence for use in pediatrics is limited but favorable in select situations (e.g., severe visual impairment, autism, other neurodevelopmental disabilities, and phase shifts). Possible side effects include daytime drowsiness, bed wetting, diarrhea, dizziness, nausea, headaches, and increased risk of seizures in children with severe neurodevelopmental disorders. [Anderson: 2019] Vivid dreams may occur. [Anderson: 2019] There is not much information about long-term side effects; although, it may lose effectiveness if used chronically and is contraindicated in autoimmune disorders. It can be used with other sleep agents.

Since melatonin is an over-the-counter natural supplement and not regulated by the FDA, the quality can vary, and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination. Caution families against purchasing melatonin with additional ingredients (e.g., l-theanine, 5+HTP, GABA) as these can be activating in some children and may have additional side effects and medication interactions.

• Short-acting melatonin: instant-release
  • Special considerations: Not recommended for treatment for night awakenings. Can cause daytime drowsiness or increase seizure frequency. [Blackmer: 2016] Can give 30-60 minutes before bedtime to aid sleep onset or 3-6 hrs before bed if managing phase-shifting. There is little evidence for dosing higher than 5 mg.
  • Formulations: Liquid, tablet, chewable tablet or gummy, capsule, oral disintegrating tablet, sublingual liquid and spray
  • Pediatric dosing:
    • 6 mos – 14 years: Typically 2-5 mg, although doses as low as 0.3 mg may be just as effective
    • >14 yrs: 5 mg, although doses as low as 0.3 mg may be just as effective
    • Alternate dosing: Lower doses (0.3-0.5 mg) have been effective for treatment of jet lag and 0.5 mg doses for sleep/wake disorders associated with blindness.
• Long-acting melatonin: slow-release, sustained-release, controlled-release, time-release
  • Special considerations: Little pediatric research on its use. Perceived to have slower onset and longer duration of action than short-acting melatonin. Some formulations contain both short- and long-acting components.
  • Formulations: Tablets, capsules, oral dissolving tablets, chewable tablets, sublingual spray
  • Pediatric dosing: The same as short-acting melatonin, above

Iron (e.g., ferrous sulfate): FDA-approved for treatment of iron deficiency anemia, this medication is used in pediatrics as an off-label treatment for restless leg syndrome (RLS) or periodic limb movement disorder (PLMD) during sleep in patients with low iron stores. If an adult patient is suffering from RLS or PLMD, it is standard practice to treat with iron supplementation if ferritin levels are less than 50-75 ng/mL. Although current guidelines have not identified sufficient evidence to recommend treatment with oral iron for children with these sleep disorders, there is evidence that iron supplementation for at least 3 months did help improve symptoms in children with RLS and PLMD. [Allen: 2018]

• Special considerations: Milk, antacids, H2-receptor blockers, and proton-pump inhibitors can inhibit absorption of iron. Constipation can occur. Poor palatability is a common reason for discontinuation of iron.
• Formulations: Liquid, tablet
• Pediatric dosing:
  • Initial: 1-2 mg/kg/day of elemental iron in divided doses
  • Titrate as needed to increase ferritin to at least 50 ng/mL
  • Maximum dose: Typically 6 mg of elemental iron/kg/day

Diphenhydramine: An antihistamine used in short-term treatment of allergic and upper respiratory symptoms, this histamine-1 receptor blocker had mixed results when compared to placebo in shortening sleep latency and decreasing the frequency of night awakenings. [Felt: 2014] It had no impact on duration of sleep or frequency of nightmares. It is usually not advised as a first-line treatment for pediatric sleep problems. It is sometimes used to treat short-term sleep problems, although the packaging insert advises against this practice.

• Special considerations: Daytime sleepiness may be a problem. It is likely to lose effectiveness when used chronically. Some children may react paradoxically with irritability and agitation. An overdose results in anticholinergic effects and impaired consciousness.
• Formulations: Liquid, tablet, chewable tablet, capsule, oral strip (melts in mouth)
• Pediatric dosing: 0.5-1 mg/kg up to 25 mg [Bruni: 2018]

5-OH tryptophan: A precursor of serotonin and melatonin that increases serotonin (5-hydroxytryptamine receptors (5-HT)) synthesis in the central nervous system. It has not been studied in pediatric populations.

• Special considerations: Supplements are not FDA regulated, so quality may vary.
• Formulations: Tablet, capsule, powder
• Pediatric dosing: 2-5 mg [Bruni: 2018]

Vitamin D: Supplements are not FDA regulated, so quality may vary. In 2019, labeling requirements changed to require metric measurements instead of international units. [Bruni: 2018]

• Special considerations: Supplements are not FDA regulated, so quality may vary. See Calcium and Vitamin D.
• Formulations: Liquid, tablet, capsules, also included in various chewable and gummy multivitamins
• Pediatric dosing:
  • Initial: 1000-2000 IU/day (25-50 mcg/day) x 6 weeks
  • Maintenance: 400-800 IU/day (10-20 mcg/day)

Clonidine (Catapres, Kapvay): An alpha-2-noradrenergic agonist indicated by the FDA to treat high blood pressure, clonidine is also known for its sedating side effects. The long-acting form of clonidine (Kapvay) is indicated as a treatment for ADHD. Clonidine is often prescribed off-label to help children with other neurodevelopmental disorders, particularly those with comorbid tic disorders, self-injurious or hyper-aroused behaviors, and sleep disturbance. Because the medication lowers blood pressure and heart rate, monitor vitals at initiation and dose increases. Consider an ECG if using this medication when there is a history of heart disease or family history of sudden death/arrhythmia. Wean over 1 to 2 weeks to avoid rebound hypertension and other withdrawal symptoms.

• Special considerations: Withdrawal is more likely in children routinely taking high doses (e.g., >0.2 mg) or receiving daytime doses as well. Be aware of the use of both milligrams (mg) and micrograms (ug) below.
• Formulations: Tablet (weekly patch, epidural available for round-the-clock dosing)
• Pediatric dosing:
  • Initial: 0.025-0.05 mg at bedtime (or ~2-3 micrograms/kg/dose for younger children)
  • Titrate by 0.025 mg increments (~5-10 micrograms/kg/day) every 1-2 weeks as tolerated
  • Maximum dose: By weight: 27-40.5 kg = 0.2 mg/day, 40.5-45 kg = 0.3 mg/day, >45 kg = 0.4 mg/day; however, usual max is 0.2 mg
  • Alternative dosing: Weight-based max = 10 micrograms/kg/day [Blackmer: 2016]

Guanfacine (Tenex, Intuniv): The long-acting form of this alpha-2-noradrenergic agonist (Intuniv) is FDA-approved as a treatment for ADHD. It is typically dosed around-the-clock for ADHD, tics, or pervasive developmental disorders. While it can cause mild sedation, it is generally not used as a pediatric sleep medication.

Prazosin (Minipress): This is an alpha-1 blocker antihypertensive indicated for treatment of hypertension. It has been studied in adults to treat nightmares associated with post-traumatic stress disorder (PTSD), and it seems helpful as an off-label treatment for insomnia in some adolescents.

• Special considerations: This is not a first-line treatment for insomnia in adults or pediatric patients. Can cause priapism. Monitor for drug-drug interactions. Wean over 1 to 2 weeks to avoid rebound hypertension and other withdrawal symptoms.
• Formulations: Oral capsule
• Pediatric dosing:
  • Initial: 1 mg at night
  • Titrate: Increase by 1 mg every 3-5 days up to 2-4 mg
  • Maximum dose: 4 mg/night

Gabapentin (Neurontin): A gamma-aminobutyric acid (GABA) analogue indicated for treatment of adult post-herpetic neuralgia and certain adult and pediatric seizure disorders. It is also frequently off-label to treat restless legs syndrome. The sedating side effects have gained increasing popularity for use as sleep medication for children with neurodevelopmental disorders or cerebral palsy. Consider using when a child moves a lot and it is unclear whether the movement is seizure activity.

• Special considerations: Risk of neuropsychiatric adverse reactions in children 3 to 12 years of age. Can cause weight gain, activation, or behavioral problems in children. Be cautious if used with other central nervous system depressants. Do not use with magnesium or aluminum-containing antacids. Do not discontinue suddenly.
• Formulations: Capsules, extended-release tablets, oral solution, compounded solution
• Pediatric dosing for ages 3 and older: [Bruni: 2018]
  • Initial: 3-5 mg/kg before bedtime
  • Titrate by 3-5 mg/kg every 3-7 days as tolerated
  • Maximum dose: 15 mg/kg

Antidepressants are sometimes used to help sleep by taking advantage of their effects on neurotransmitters that affect sleep. The FDA warns, “Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.”

Trazodone (Desyrel): Indicated for treatment of depression, this second-generation or “atypical” antidepressant is sometimes used off-label to aid with sleep because drowsiness is a prominent side-effect. Common side effects are dizziness, light-headedness, dry mouth, nausea, and vomiting. Priapism can occur; if an erection is persistent, the male should go to an emergency room. This medication tends to last longer, so it may be helpful for very early risers, but it also can cause excessive daytime sleepiness.

• Special considerations: Avoid use in children 0-3 yrs old or if there is history of hypotension. Can increase suicidal thinking in pediatric patients.
• Formulations: Tablets
• Pediatric dosing:
  • Initial: 1-2 mg/kg/dose at bedtime
  • Titrate by 12.5-25 mg increments every 2 wks as tolerated [Blackmer: 2016]
  • Max dose: age 3-5 years = 100 mg, >5 yrs = 200 mg
  • Alternate dosing: Start at 12.5 mg (quarter tablet) for smaller children, 25 mg (half tablet) for larger children

Mirtazapine (Remeron): Indicated for treatment of major depressive disorder, this antidepressant works as an α2‐adrenergic, 5‐HT receptor agonist. It is prescribed off-label by some providers to help in sleep onset and maintenance due to its sedating properties at low doses.

• Special considerations: Can increase suicidal thinking in pediatric patients
• Formulations: Tablet, oral disintegrating tablet
• Pediatric dosing: 3.75 – 15 mg

Amitriptyline (Elavil): A tricyclic antidepressant (TCA) occasionally used off-label as an aid for sleep maintenance for people with chronic pain or depression.

• Special considerations: Cardiac rhythm disturbances can be caused by tricyclic antidepressants, and a baseline EKG may be indicated. Parents should know that an overdose can be life-threatening; keep medication safely out of reach of all children in the household. It can increase suicidal thinking in pediatric patients.
• Formulations: Tablet
• Pediatric dosing: 5-25 mg [Bruni: 2018]

Citalopram (Celexa) and fluvoxamine (Luvox), both selective serotonin reuptake inhibitors (SSRIs), can cause some sedation and therefore are sometimes selected for treatment of anxiety-related sleep problems.

Hydroxyzine (Vistaril): Like diphenhydramine, hydroxyzine is a histamine-1 receptor blocker, which also had mixed results when compared to placebo in shortening sleep latency and decreasing the frequency of night awakenings. [Felt: 2014] It is usually not used as a first-line treatment for pediatric sleep problems. It is sometimes prescribed for short-term sleep problems. It is FDA-indicated for treatment of some forms of anxiety, tension, pruritus, and a sedative during anesthesia. (Atarax, another well-known brand name, was discontinued in the U.S.)

• Special considerations: Daytime sleepiness may be a problem. It is likely to lose effectiveness when used chronically. Some children may react paradoxically with irritability and agitation. An overdose results in anticholinergic effects and impaired consciousness.
• Formulations: Liquid, tablet, capsule
• Pediatric dosing: 0.5-1 mg/kg [Bruni: 2018]

See the Over-the-Counter section, above, for diphenhydramine.

Used for severe mood or thought disorders, the sedating side effects of these medications may help with insomnia that is comorbid with aggressive or self-injurious behaviors. These medications require regular monitoring for weight gain, metabolic effects, and extrapyramidal side effects. Increases risk of suicidal thinking, drug reaction eosinophilia and systemic symptoms (DRESS), sleep-walking, sleep-related eating disorders, and other side effects. Given their high-risk profile and lack of safety data for use in children, using these medications routinely for sleep is not advised. Consultation is advised.

Quetiapine (Seroquel): FDA-approved for treatment of adults and adolescents with schizophrenia or manic episodes associated with bipolar disorder; also FDA-approved for treatment of adult depression associated with bipolar disorder.

• Special considerations: Consultation with psychiatry is advised before use.
• Formulations: Tablet, solution, oral dissolving tablet
• Pediatric dosing: 25 - 50 mg

Risperidone (Risperdal): FDA-approved for treatment of irritability in children with autism ages 5-16, as well as for adolescent (and adult) treatment of schizophrenia and manic or mixed episodes of bipolar disorder.

• Special considerations: Consultation with psychiatry is advised before use.
• Formulations: Tablet, solution, oral dissolving tablet
• Pediatric dosing: 0.5 – 2 mg [Bruni: 2018]

Aripiprazole (Abilify): FDA-approved for treatment of irritability in children with autism, as well as for treatment of schizophrenia, Tourette’s disorder, major depressive disorder, and manic or mixed episodes of bipolar disorder. The intramuscular injection is indicated for treatment of agitation associated with schizophrenia or bipolar mania.

• Special considerations: Consultation with psychiatry is advised before use.
• Formulations: Tablet, solution, oral dissolving tablet, intramuscular injection
• Pediatric dosing: 1-5 mg [Bruni: 2018]

Sedative/hypnotic medications fall into 2 categories: benzodiazepines, such as clonazepam or diazepam, and non-benzodiazepine hypnotics or “Z” drugs, such as zolpidem, eszopiclone, or zaleplon. These medications are not highly effective in children. They are listed here as a reference. Strongly consider consulting with a specialist prior to prescribing any sedative/hypnotic medications for pediatric sleep problems. Sedative/hypnotic medications are not frequently used in pediatrics

Benzodiazepines Sedatives/Hypnotics

Non-Benzodiazepine Sedative-Hypnotics (“Z drugs”)