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.
Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia.
At the recent SEC meeting for Neurology and Psychiatry held on 17 August 2023, the expert panel reviewed the bioequivalence study report presented by Troikaa Pharmaceuticals for Zolpidem Sublingual Spray 3.85 % w/v.
The committee noted that the Zolpidem Orally Disintegrating Tablets (ODT) and extended-release tablets were already approved in the country.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Zolpidem sublingual spray 3.85 % w/v with a clinical trial waiver for the proposed indication, subject to the following conditions:
1. The firm should conduct a Phase IV clinical trial,
2. The firm should submit data on potential dependence that may be caused by to use of Zolpidem Tartrate sublingual spray.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months of approval.
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