Application Nr Approved Date Route Status External Links
NDA018708 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Quazepam Is Indicated For The Treatment Of Insomnia Characterized By Difficulty In Falling Asleep, Frequent Nocturnal Awakenings, And/or Early Morning Awakenings. The Effectiveness Of Quazepam Has Been Established In Placebo-Controlled Clinical Studies Of 5 Nights Duration In Acute And Chronic Insomnia. The Sustained Effectiveness Of Quazepam Has Been Established In Chronic Insomnia In A Sleep Lab (Polysomnographic) Study Of 28 Nights Duration. Because Insomnia Is Often Transient And Intermittent, The Prolonged Administration Of Quazepam Tablets Is Generally Not Necessary Or Recommended. Since Insomnia May Be A Symptom Of Several Other Disorders, The Possibility That The Complaint May Be Related To A Condition For Which There Is A More Specific Treatment Should Be Considered. Quazepam, A Gamma-Aminobutyric (Gabaa) Agonist, Is Indicated For The Treatment Of Insomnia Characterized By Difficulty Falling Asleep, Frequent Nocturnal Awakenings, And/or Early Morning Awakenings. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Quazepam QUAZEPAM ZINC538266

Comments