Medications for sleep

Medications which may be helpful (in the short-term) to treat 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 also 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 "natural", it is important to note that there has been little investigation into the potential side effects that might be associated with long-term usage of this drug. In addition, since sold as a natural supplement, the manufacturing of this compound is not regulated by the FDA, leading to potential for variation in quality within and across preparations. There is some suggestion 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 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 good to children. Ramelteon (Rozarem) is a new 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's likely to lose effectiveness when used chronically. Be aware that some children may react paradoxically with irritability and agitation.

Clonidine: is a 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 night-time dose is 0.025 - 0.1 mg given 30 minutes before bedtime. When using longer than a single night-time 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. Note 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 taking multiple daytime doses for treatment of AD/HD. 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, children may benefit from this medication, particularly children who are expected to have short term sleeping problems such as 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 since 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 day-time 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 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 negatively impact 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 currently and there are not any recommendations in the pediatric literature.