What is Hetlioz (tasimelteon)?
Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
The precise mechanism by which tasimelteon exerts its therapeutic effect in patients with Non24 is not known. Tasimelteon is an agonist at melatonin MT1 and MT2 receptors. These receptors are thought to be involved in the control of circadian rhythms.
What are the side effects of Hetlioz?
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 1346 subjects were treated with at least one dose of Hetlioz, of which 139 were treated for > 26 weeks and 93 were treated for > 1 year.
A 26-week, parallel-arm placebo-controlled study (Study 1) evaluated Hetlioz (n=42) compared to placebo (n=42) in patients with Non-24. A randomized-withdrawal, placebo-controlled study of 8 weeks duration (Study 2) also evaluated Hetlioz (n=10), compared to placebo (n=10), in patients with Non-24.
In placebo-controlled studies, 6% of patients exposed to Hetlioz discontinued treatment due to an adverse event, compared with 4% of patients who received placebo.
Table 1 shows the incidence of adverse reactions from Study 1.
Table 1: Adverse Reactions in Study 1
|Hetlioz N=42||Placebo N=42|
|Headache||17 %||7 %|
|Alanine aminotransferase increased||10 %||5 %|
|Nightmare/abnormal dreams||10 %||0 %|
|Upper respiratory tract infection||7 %||0 %|
|Urinary tract infection||7 %||2 %|
|*Adverse reactions with an incidence > 5% and at least twice as high on Hetlioz than on placebo are displayed.|
Can you get addicted to Hetlioz?
Tasimelteon is not a controlled substance under the Controlled Substances Act.
Tasimelteon did not produce any abuse-related signals in animal behavioral studies. Rats did not self-administer tasimelteon, suggesting that the drug does not have rewarding properties. There were also no signs or symptoms indicative of abuse potential in clinical studies with Hetlioz.
Discontinuation of Hetlioz in humans following chronic administration did not produce withdrawal signs. Hetlioz does not appear to produce physical dependence.
What is the dosage for Hetlioz?
The recommended dosage of Hetlioz is 20 mg per day taken before bedtime, at the same time every night.
Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months.
Hetlioz should be taken without food.
Dosage Forms And Strengths
Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “Vanda 20 mg” in white.
What drugs interact with Hetlioz?
Strong CYP1A2 Inhibitors (e.g., fluvoxamine)
Avoid use of Hetlioz in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions.
Strong CYP3A4 Inducers (e.g., rifampin)
Avoid use of Hetlioz in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy.
Is Hetlioz safe to take while pregnant or breastfeeding?
There are no adequate and well-controlled studies of Hetlioz in pregnant women. In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofetal mortality, neurobehavioral impairment, and decreased growth and development in offspring) at doses greater than those used clinically. Hetlioz should be used during pregnancy only if the potential benefit justifies the potential risks.
Hetlioz (tasimelteon) treats non-24 hour sleep-wake disorder (Non24). Blind people and shift workers are subject to this circadian rhythm disorder, which describes an alteration of their sleep cycle that is severe enough to affect daily life. Hetlioz is non-addictive, but potential side effects include headache, vivid dreams or nightmares and increased susceptibility to some respiratory infections.
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Related Disease Conditions
Sleep apnea is defined as a reduction or cessation of breathing during sleep. The three types of sleep apnea are central apnea, obstructive apnea (OSA), and a mixture of central and obstructive apnea. Central sleep apnea is caused by a failure of the brain to activate the muscles of breathing during sleep. OSA is caused by the collapse of the airway during sleep. OSA is diagnosed and evaluated through patient history, physical examination and polysomnography. There are many complications related to obstructive sleep apnea. Treatments are surgical and non-surgical.
A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about 7-9 hours of sleep each night for older, school-aged children, teens, and most average adults; 10-12 for preschool-aged children; and 16-18 hours for newborns. There are two stages of sleep: 1) REM sleep (rapid-eye movement), and 2) NREM sleep (non-rapid-eye movement).
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Sleep needs in children and teenagers depend on the age of the child. Sleep disorders in children such as: sleep apnea, parasomnias, confusional arousals, night terrors, nightmares, narcolepsy, and sleepwalking which can affect a child's or teen's sleep. Healthy sleep habits and good sleep hygiene can help your infant, toddler, preschooler, tween, or teenager get a good night's sleep.
Insomnia Treatment (Sleep Aids and Stimulants)
Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions, environmental changes, and stressful events. Treatments may include non-drug treatments, over-the-counter medicines, and/or prescription medications.
Sleep Related Breathing Disorders
Sleep-related breathing disorders are characterized by disruptions of normal breathing patterns that only occur during sleep. Snoring and sleep apnea are the most common sleep-related breathing disorders.
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.