Brotizolam

Overview

Brotizolam is a sedative-hypnotic thienodiazepine drug which is a benzodiazepine analog. It demonstrates anxiolytic, anticonvulsant, hypnotic, sedative and skeletal muscle relaxant effects. Brotizolam has similar effects to short-acting benzodiazepines such as triazolam. Brotizolam is indicated for 2-4 weeks of treatment for severe or debilitating insomnia. Brotizolam is an extremely potent drug and it is rapidly eliminated with an average half-life of 4.4 hours (range 3.6 - 7.9 hours). Brotizolam is not approved for sale in the UK, United States or Canada but is sold in the Netherlands, Germany, Spain, Belgium, Austria, Portugal, Israel, Italy and Japan.

Indication

Brotizolam is indicated for 2-4 weeks in the treatment of severe or debilitating insomnia.

Associated Conditions

Insomnia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Treatment With Benzodiazepine After Cardiac Surgery	2016/05/18	NCT02776228	Phase 3	UNKNOWN	Rambam Health Care Campus
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males	2014/08/18	NCT02218658	Phase 1	Completed	Boehringer Ingelheim
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males	2014/08/18	NCT02218645	Phase 1	Completed	Boehringer Ingelheim
To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers	2011/05/26	NCT01361022	Phase 1	Completed	Boehringer Ingelheim
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.	2006/07/04	NCT00347295	Phase 3	Completed	Boehringer Ingelheim

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SINTONAL 0,25 mg comprimidos	Boehringer Ingelheim Espana S.A.	58229	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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