NDLI: Safety profile of tasimelteon, a melatonin MT1 and MT2 receptor agonist: pooled safety analyses from six clinical studies.

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Safety profile of tasimelteon, a melatonin MT1 and MT2 receptor agonist: pooled safety analyses from six clinical studies.

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Safety profile of tasimelteon, a melatonin MT1 and MT2 receptor agonist: pooled safety analyses from six clinical studies.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Leger, Damien Quera-Salva, Maria-Antonia Vecchierini, Marie-Françoise Ogrizek, Pascale Perry, Christina A. Dressman, Marlene A.
Description	Author Affiliation: Leger D ( a 1 Université Paris Descartes, APHP, Hôtel-Dieu de Paris, Centre du Sommeil et de la Vigilance , 1 place du Parvis Notre Dame, 75181 Paris cedex 04, Paris, France +33 1 42 34 82 43 ); Quera-Salva MA ( b 2 Université Paris Descartes, EA 7330 VIFASOM Sommeil-Vigilance-Fatigue et Santé Publique , Paris, France.); Vecchierini MF ( c 3 APHP, Hôpital Raymond Poincaré, Unité de sommeil , Garches, France.); Ogrizek P ( a 1 Université Paris Descartes, APHP, Hôtel-Dieu de Paris, Centre du Sommeil et de la Vigilance , 1 place du Parvis Notre Dame, 75181 Paris cedex 04, Paris, France +33 1 42 34 82 43 ); Perry CA ( b 2 Université Paris Descartes, EA 7330 VIFASOM Sommeil-Vigilance-Fatigue et Santé Publique , Paris, France.); Dressman MA ( a 1 Université Paris Descartes, APHP, Hôtel-Dieu de Paris, Centre du Sommeil et de la Vigilance , 1 place du Parvis Notre Dame, 75181 Paris cedex 04, Paris, France +33 1 42 34 82 43 )
Abstract	INTRODUCTION: Tasimelteon, a novel circadian regulator, is the first product for the treatment of Non-24-hour Sleep-Wake Disorder (Non-24) approved by either the FDA or the European Medicines Agency (EMA). Tasimelteon is a potent and specific melatonin (MT1 and MT2) receptor agonist with 2 - 4 times greater affinity for the MT2 receptor. 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.
File Format	HTM / HTML
ISSN	14740338
Issue Number	11
Volume Number	14
e-ISSN	1744764X
Journal	Expert Opinion on Drug Safety
Language	English
Publisher	Taylor & Francis
Publisher Date	2015-01-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Benzofurans Adverse Effects Cyclopropanes Receptor, Melatonin, Mt1 Agonists Receptor, Melatonin, Mt2 Administration & Dosage Pharmacology Humans Sleep Disorders, Circadian Rhythm Drug Therapy Sleep Initiation And Maintenance Disorders Time Factors Journal Article Meta-analysis
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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