Troikaa Gets CDSCO panel nod to manufacture, market sedative drug Zolpidem sublingual spray
New Delhi: The drug major Troikaa Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the sedative drug Zolpidem sublingual spray 3.85 %.
However, this approval is subject to the condition that Troikaa Pharmaceuticals should conduct a Phase IV clinical trial and submit data on potential dependence that may be caused due to the use of Zolpidem Tartrate sublingual spray.
This came after Troikaa Pharmaceuticals presented a bioequivalence study report of Zolpidem Sublingual Spray 3.85 % w/v before the committee.
Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic substance with a chemical structure that is not related to the structure of benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines or other drugs exerting hypnotic effects. It interacts with a GABA-BZ receptor complex and shares various pharmacological properties with the benzodiazepine class of drugs.
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