Tofisopam

Evidence Level: L5

Predicted Indications: 1

Tofisopam

Pharmacist Assessment Report

Tofisopam: Predicted New Indication Insomnia (Original Indication Not Recorded in Data)

One-Sentence Summary

Tofisopam is a single-ingredient oral tablet marketed in India, but the data compiled for this report do not record its approved indication. The TxGNN model predicts it may be effective for insomnia, but there are currently 0 clinical trials and 0 publications supporting this direction. The prediction is therefore model-derived only.

Quick Overview

Item	Content
Original Indication	Not recorded in the compiled data (all license entries have empty indication text)
Predicted New Indication	Insomnia
TxGNN Prediction Score	0.9916
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (11 of 11) – CDSCO approval status is not included in this data
Number of Listed Products	11 (valid: 11)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. The compiled data record neither a mechanism nor an approved indication for tofisopam, so a mechanistic link to insomnia cannot be verified from the available information.

From general pharmacology (outside the compiled data, to be verified), tofisopam is a 2,3-benzodiazepine that does not act through classical GABA-A benzodiazepine-site agonism. It is generally described as non-sedating, anxiolytic and activating. That profile argues against a straightforward hypnotic effect.

The high score of 0.9916 comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, such as other benzodiazepines, not biological evidence. No pathway-level support is available.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

All 11 registrations are valid single-ingredient oral tablets (strips of 10 tablets). Approved indication text is not recorded for any of them. The table lists 5 of the 11.

Authorization Number	Product Name	Dosage Form	Approved Indication
224070	Tofiryd 100 Tablet (Ryon Pharma)	Strip of 10 tablets	Not recorded
150675	Nextril 50 Tablet (Torrent Pharmaceuticals Ltd)	Strip of 10 tablets	Not recorded
215517	Toficalm 100 Tablet (Sun Pharmaceutical Industries Ltd)	Strip of 10 tablets	Not recorded
215998	Tofisern 50mg Tablet (Consern Pharma Limited)	Strip of 10 tablets	Not recorded
218347	Tofypeace 50 Tablet (Psychocare Health Pvt Ltd)	Strip of 10 tablets	Not recorded

Safety Considerations

Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests only on a model score, with no clinical trials or publications. The available pharmacology also suggests that a non-sedating, activating profile is not consistent with a hypnotic effect. Safety information and the approved indication are missing as well.

To proceed, the following is needed:

The package insert from the India regulatory source, to confirm the approved indication, warnings and contraindications
Mechanism of action data (for example from DrugBank) to test whether any plausible link to sleep regulation exists
A targeted search of trials and literature on tofisopam in insomnia and sleep outcomes
Preclinical or exploratory clinical data on sleep effects before reconsidering the decision
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.