Related Experiment Video
Updated: Oct 26, 2025

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
Tasimelteon safely and effectively improves sleep in Smith-Magenis syndrome: a double-blind randomized trial followed
Christos M Polymeropoulos1, Justin Brooks1, Emily L Czeisler1
1Vanda Pharmaceuticals Inc., Washington, DC, USA.
Purpose:
To assess the efficacy of tasimelteon to improve sleep in Smith-Magenis syndrome (SMS).
Methods:
A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months.
Results:
Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon.
Conclusion:
Tasimelteon safely and effectively improved sleep in SMS.
More Related Videos
Related Concept Videos
Management of Insomnia
Sedatives and Hypnotics Drugs: Miscellaneous Agents
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
Blind Procedures
Substance Use Disorders Affecting Sleep
Understanding the concepts of physical dependence,...
Narcolepsy
Insufficient Sleep and Sleep Deprivation
Sleep deprivation is a more severe form of sleep loss...

