Medications for Sleep

The following are medications that may be helpful for short-term treatment of sleep problems.
Melatonin is a natural brain hormone that appears to be involved in setting biologic rhythms. It may induce sleepiness in some individuals and can be helpful in adjusting biologic rhythms (e.g., help with sleep cycles in individuals with severe visual impairment). Short-acting (primarily to help with sleep onset) and long-acting preparations (to help with sleep maintenance) are marketed. While melatonin is "natural," little has been investigated about potential side effects associated with long-term use. In addition, since sold as a natural supplement, the FDA does not regulate manufacturing of this compound, leading to potential for variation in quality within, and across, preparations. Some suggest that this preparation may also lose effectiveness when used chronically. Research in pediatrics is limited, but suggests that melatonin may be useful in select situations (e.g., severe visual impairment, autism and other neurodevelopmental disabilities, phase shifts). The dosages used in these studies vary (2-12 mg), but 5 mg taken 60 - 90 minutes before bed appears to be a common dose. Melatonin may be used in conjunction with other sleep agents. Increasing the dose past 10 mg or giving a second dose during the night does not seem to be helpful. Melatonin is available over the counter and parents should be advised to use the same preparation consistently. The form from GNC tastes may taste good to children. Ramelteon (Rozarem) is a synthetic melatonin and may also be useful. See Rozarem information (from the manufacturer).
Diphenhydramine has been shown to be more effective than placebo in shortening sleep latency and decreasing the frequency of night awakenings. In a pediatric study, the dose used was 1mg/kg at bedtime. It had no impact on duration of sleep or frequency of nightmares. Daytime sleepiness may be a problem. It is likely to lose effectiveness when used chronically. Be aware that some children may react paradoxically with irritability and agitation.
Clonidine is an Alpha-2-noradrenergic agonist used in adults for treatment of hypertension. Clonidine has been evaluated and used in children primarily for the treatment of ADHD with co-morbid tic disorders, hyper-aroused behaviors, or sleep disturbance. Clonidine has also been used to sedate children for EEG. Dosage range for a single nighttime dose is 0.025 - 0.1 mg given 30 minutes before bedtime. When using longer than a single nighttime dose, the starting nighttime dose of clonidine is calculated at 1.25 micrograms per kilogram of body weight orally. (One study of children age 4-17 years used bedtime dosages initially of 0.05 mg QHS and worked up by 0.05 mg intervals to a maximum of 0.4 mg QHS to aid sleep. This is much higher than the standard guidelines for dosing, but no untoward side effects were noted.) Withdrawal can be seen if a child has taken clonidine chronically and is more likely in children on higher dosages or in children who are taking multiple daytime doses for treatment of ADHD. Withdrawal symptoms include nausea, agitation, and hypertension. In children using relative high doses over a long period, clonidine should be weaned over 1-2 weeks. Several cases of sudden death have been reported in children who were on the combination of methylphenidate and clonidine. While this combination is still used and often helpful clinically, some caution should be exercised. Withdrawal potential should be discussed with parents along with the need to wean the agent. A history of heart disease or family history of sudden death/arrhythmia is a relative contraindication to the use of clonidine. Some authors suggest a baseline EKG be performed before using this agent.
Chloral Hydrate: While often used in the clinical setting to sedate patients for non-painful procedures and for short-term treatment of sleep problems, chloral hydrate use in the outpatient pediatric setting and as a chronic intervention for sleep disorder is cautioned in many publications. However, some children may benefit from this medication, particularly those who are expected to have short-term sleeping problems (e.g., children with CP in hip-spica casts discharged home on a dose of chloral hydrate that has been useful and safe for them in the hospital). Caution must be exercised due to potential for sedation, exacerbation of obstructive sleep apnea, paradoxical responses, and loss of effect over the long term.
Trazodone is a second-generation antidepressant that is sometimes used to aid with sleep because drowsiness is a prominent side-effect. Common side effects are dizziness, lightheadedness, dry mouth, nausea, and vomiting. Priapism requiring surgical intervention occurs in 1/15,000 males - male patients who have prolonged or inappropriate erections should be told to discontinue use and contact their physician. If an erection is persistent, the male should go to an emergency room. When used for its antidepressant properties, dosage guidelines for ages 6-18 are 1.5-2 mg/kg/day in divided doses, titrating gradually upwards at 3-4 day intervals to a maximum of 6 mg/kg/day. Sleep is an off-label indication, but many providers will start at a very low dose of 1/4 to 1/2 of a 50 mg tablet (1/4 for smaller children) for the treatment of sleep problems in children over 3. The dosage is then titrated up as necessary, and it is unlikely that the dosage for depression (2 mg/kg qHS) will be needed. It should not be used in children with a history of cardiac problems and the parents should watch for excessive daytime sleepiness, which might limit its use.
Tricyclic antidepressants: Imipramine and amitriptyline are often used as an aid for sleep in individuals with chronic pain. Case reports have suggested that it may be helpful in the treatment of night terrors and sleep walking. Cardiac rhythm disturbances can be caused by tricyclic antidepressants. A baseline EKG may be indicated. Furthermore, if prescribing this medication, the parent should be educated about its potential for life-threatening impacts if taken in overdose and, therefore, the need to keep it safely out of reach of all children in the household.
Benzodiazepines: There has been little evaluation of the use of benzodiazepines in children for treatment of chronic sleep disorders and, given their addictive potential, their use on a chronic basis is cautioned. Clinically, clonazepam is sometimes used in children with brain disorders who have severe irritability and may also help with sleep. A dose of valium or tranxene, given at bedtime, is sometimes useful to help when spasticity is impairing sleep onset.
Ambien (zolpidem tartrate) is a short-acting hypnotic drug. It is helpful in reducing sleep latency, but not for sleep maintenance. Research has suggested that this medication may be less likely than other medications (e.g., halcion) to impact negatively deep sleep duration and to have less potential for addiction. Pediatric use has been limited and there are no set dosing guidelines.
Remeron is being used by some providers, but this is an off-label use and there are no recommendations in the pediatric literature.


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Helpful Articles

Ramchandani P, Wiggs L, Webb V, Stores G.
A systematic review of treatments for settling problems and night waking in young children.
BMJ. 2000;320(7229):209-13. PubMed abstract / Full Text

Schnoes CJ, Kuhn BR, Workman EF, Ellis CR.
Pediatric prescribing practices for clonidine and other pharmacologic agents for children with sleep disturbance.
Clin Pediatr (Phila). 2006;45(3):229-38. PubMed abstract

Owens JA, Babcock D, Blumer J, Chervin R, Ferber R, Goetting M, Glaze D, Ivanenko A, Mindell J, Rappley M, Rosen C, Sheldon S.
The use of pharmacotherapy in the treatment of pediatric insomnia in primary care: rational approaches. A consensus meeting summary.
J Clin Sleep Med. 2005;1(1):49-59. PubMed abstract

Owens JA, Rosen CL, Mindell JA.
Medication use in the treatment of pediatric insomnia: results of a survey of community-based pediatricians.
Pediatrics. 2003;111(5 Pt 1):e628-35. PubMed abstract

Moore M, Allison D, Rosen CL.
A review of pediatric nonrespiratory sleep disorders.
Chest. 2006;130(4):1252-62. PubMed abstract

Authors & Reviewers

Initial publication: September 2008; last update/revision: May 2015
Current Authors and Reviewers:
Reviewers: Meghan Candee, MD
Lisa Samson-Fang, MD