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Medications for Smith-Magenis Syndrome Sleep Disturbance

Other names: SMS Sleep Disturbance

About Smith-Magenis Syndrome Sleep Disturbance

Smith-Magenis syndrome (SMS) is a rare, developmental disorder characterized by mild to moderate intellectual disability, delayed speech and language skills, distinctive facial features, severe behavioral problems, and sleep disturbances. It is caused by deletions and mutations of the RAI1 gene on chromosome 17p11.2.

The sleep disturbances associated with Smith-Magenis syndrome are thought to be due to abnormal melatonin secretion and a dysregulation of molecular circadian rhythms, resulting in frequent nighttime waking, early sleep onset, early waking, frequent daytime napping, and daytime sleepiness.

Tasimelteon (Hetlioz, Hetlioz LQ) is the first FDA-approved treatment for patients with SMS.

Drugs used to treat Smith-Magenis Syndrome Sleep Disturbance

The following list of medications are in some way related to, or used in the treatment of this condition.

Drug name Rating Reviews Activity Rx/OTC Pregnancy CSA Alcohol
Hetlioz Rate Add review
Rx C N X

Generic name: tasimelteon systemic

Drug class: miscellaneous anxiolytics, sedatives and hypnotics

For consumers: dosage, interactions, side effects

For professionals: Prescribing Information

tasimelteon Rate Add review
Rx C N X

Generic name: tasimelteon systemic

Brand name:  Hetlioz

Drug class: miscellaneous anxiolytics, sedatives and hypnotics

For consumers: dosage, interactions, side effects

For professionals: A-Z Drug Facts, AHFS DI Monograph

For ratings, users were asked how effective they found the medicine while considering positive/adverse effects and ease of use (1 = not effective, 10 = most effective).

Legend

Rx Prescription Only
OTC Over the Counter
Rx/OTC Prescription or Over the Counter
Off-label This medication may not be approved by the FDA for the treatment of this condition.
Pregnancy Category
A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use in pregnant women despite potential risks.
D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use in pregnant women despite potential risks.
X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use in pregnant women clearly outweigh potential benefits.
N FDA has not classified the drug.
Controlled Substances Act (CSA) Schedule
N Is not subject to the Controlled Substances Act.
1 Has a high potential for abuse. Has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use under medical supervision.
2 Has a high potential for abuse. Has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence.
3 Has a potential for abuse less than those in schedules 1 and 2. Has a currently accepted medical use in treatment in the United States. Abuse may lead to moderate or low physical dependence or high psychological dependence.
4 Has a low potential for abuse relative to those in schedule 3. It has a currently accepted medical use in treatment in the United States. Abuse may lead to limited physical dependence or psychological dependence relative to those in schedule 3.
5 Has a low potential for abuse relative to those in schedule 4. Has a currently accepted medical use in treatment in the United States. Abuse may lead to limited physical dependence or psychological dependence relative to those in schedule 4.
Alcohol
X Interacts with Alcohol.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.