Nitrazepam

Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime sedation is acceptable. An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.

Benzodiazepines are not recommended for the primary treatment of psychotic illness.

AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS..................................................................................

15 PART II: SCIENTIFIC INFORMATION ......................................................................... 20 PART III: CONSUMER INFORMATION........................................................................ 22 Page 3 of 27 MOGADON® Nitrazepam Tablets BP 5 mg, 10 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Nonmedicinal Ingredients Oral Tablet / 5 mg, 10 mg croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose INDICATIONS AND CLINICAL USE Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder.