Because of individual differences in circadian rhythms,
sleep-wake cycle lengths vary from patient to patient2
References: 1. Dressman MA, et al. Poster presented at: 26th Annual Meeting of the Associated Professional Sleep Societies, LLC; June 10, 2012; Boston, MA. Poster 49. 2. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014. 3. Dibner C, et al. Annu Rev Physiol. 2010;72:517-549. 4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013. 5. Lockley SW, et al. In: Kushida C, ed. The Encyclopedia of Sleep. Vol 3. Waltham, MA: Elsevier; 2013:34-40.
The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.
HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQTM oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.
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