Abstract | INTRODUCTION: METHODS: Safety was assessed in two controlled and two open-label studies in blind individuals with Non-24 and in two controlled studies of primary insomnia. Periodic assessments included collection of adverse events (AEs), laboratory testing, electrocardiograms (ECGs), vital sign monitoring, physical examinations and assessment for the potential for suicide. One study included additional assessments for endocrine function. RESULTS: A total of 184 blind individuals with Non-24 received tasimelteon nightly with a median exposure > 1 year. In placebo-controlled studies, 387 patients with insomnia and 42 patients with Non-24 received tasimelteon nightly for 4 - 26 weeks. The total patient years exposure for the six studies assessed here is 258.64 patient years. Discontinuations due to AEs were similar across treatment groups. Overall in the clinical studies described here, AEs attributable to tasimelteon treatment were headache, diarrhea, dry mouth, alanine aminotransferase increased, somnolence, dizziness and nightmare/abnormal dreams. There were no clinically significant differences in treatment group with ECGs, vital signs, withdrawal, endocrine function and suicidality assessments. CONCLUSION: Long-term tasimelteon administration was safe and well-tolerated. This is supported by placebo-controlled data in both Non-24 and insomnia patients.
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Authors | Damien Leger, Maria-Antonia Quera-Salva, Marie-Françoise Vecchierini, Pascale Ogrizek, Christina A Perry, Marlene A Dressman |
Journal | Expert opinion on drug safety
(Expert Opin Drug Saf)
Vol. 14
Issue 11
Pg. 1673-85
( 2015)
ISSN: 1744-764X [Electronic] England |
PMID | 26393492
(Publication Type: Journal Article, Meta-Analysis)
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Chemical References |
- Benzofurans
- Cyclopropanes
- Receptor, Melatonin, MT1
- Receptor, Melatonin, MT2
- tasimelteon
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Topics |
- Benzofurans
(administration & dosage, adverse effects, pharmacology)
- Cyclopropanes
(administration & dosage, adverse effects, pharmacology)
- Humans
- Receptor, Melatonin, MT1
(agonists)
- Receptor, Melatonin, MT2
(agonists)
- Sleep Disorders, Circadian Rhythm
(drug therapy)
- Sleep Initiation and Maintenance Disorders
(drug therapy)
- Time Factors
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