Brotizolam
- Generic Name
- Brotizolam
- Drug Type
- Small Molecule
- Chemical Formula
- C15H10BrClN4S
- CAS Number
- 57801-81-7
- Unique Ingredient Identifier
- 5XZM1R3DKF
- Background
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
Treatment With Benzodiazepine After Cardiac Surgery
- First Posted Date
- 2016-05-18
- Last Posted Date
- 2016-11-10
- Lead Sponsor
- Rambam Health Care Campus
- Target Recruit Count
- 200
- Registration Number
- NCT02776228
Pharmacovigilance in Gerontopsychiatric Patients
- Conditions
- DementiaDepressionSchizophreniaPsychosomatic DisordersAnxiety Disorders
- Interventions
- First Posted Date
- 2015-03-02
- Last Posted Date
- 2018-02-28
- Lead Sponsor
- Hannover Medical School
- Target Recruit Count
- 407
- Registration Number
- NCT02374567
- Locations
- 🇩🇪
Bezirkskrankenhaus Augsburg, Augsburg, Germany
🇩🇪Krankenhaus Hedwigshöhe, Berlin, Germany
🇩🇪Hannover Medical School, Hannover, Germany
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males
- First Posted Date
- 2014-08-18
- Last Posted Date
- 2014-08-18
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 30
- Registration Number
- NCT02218658
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males
- First Posted Date
- 2014-08-18
- Last Posted Date
- 2014-08-18
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 30
- Registration Number
- NCT02218645
To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers
- First Posted Date
- 2011-05-26
- Last Posted Date
- 2013-11-01
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 24
- Registration Number
- NCT01361022
- Locations
- 🇨🇳
263.511.1 Boehringer Ingelheim Investigational Site, Taipei, Taiwan
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
- Conditions
- Sleep Initiation and Maintenance Disorders
- First Posted Date
- 2006-07-04
- Last Posted Date
- 2017-12-28
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 253
- Registration Number
- NCT00347295
- Locations
- 🇨🇳
Beijing Hospital, Beijing, China
🇨🇳Peking Union Medical College Hospital, Beijing, China
🇨🇳Shanghai Mental Health Center, Shanghai, China
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.