RESTORIL

1 Dosing Considerations  Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.

 RESTORIL should always be prescribed at the lowest effective dose for the shortest duration possible.  RESTORIL can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).

Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring.  Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure.

 If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper.  Geriatric patients in particular may be more sensitive to benzodiazepines (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).

 Long-term use of RESTORIL should be avoided in elderly patients. Enhanced monitoring is recommended. 2 Recommended Dose and Dosage Adjustment Recommended Dose Adults: the recommended dose of RESTORIL is 30 mg before retiring, 15 mg may be sufficient for some RESTORIL® (temazepam) Page 6 of 29 patients.

4 Geriatrics). 3 Pediatrics). Dosage Adjustment The lowest effective dose of RESTORIL (temazepam) should be used. Treatment with RESTORIL should usually not exceed 7-10 consecutive days. Use for more than 2-3 consecutive weeks requires complete re-evaluation of the patient.

Prescriptions for RESTORIL should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply. An appropriate hypnotic dose should produce the desired hypnotic effect while avoiding oversedation and impairment of performance the next day.

RESTORIL is intended only for short-term use and therefore, should not be prescribed in quantities exceeding those required for that cycle of administration. Prescription should not be renewed without further assessment of the patient's needs.

1 Adverse Reaction Overview In clinical trials, drowsiness, dizziness, and confusion occurred at a higher incidence in RESTORIL- treated patients as compared with placebo-treated patients. 9 % in clinical trials. There have been reports of falls and fractures in benzodiazepine users due to adverse reactions such as sedation, dizziness and ataxia (See 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. During controlled clinical trials in which 1076 patients received RESTORIL at bedtime, the Adverse Events occurring in 1% or more of patients are listed below.

9%: Cardiac Disorders: dyspnea, palpitations. Eye disorders: burning eyes. Gastrointestinal disorders: vomiting. Metabolism and nutrition disorders: anorexia. Musculoskeletal and connective tissue disorder: backache. Nervous system disorders: ataxia, equilibrium loss, tremor, increased dreaming.

Skin and subcutaneous tissue disorders: hyperhidrosis. 5%: Eye disorders: horizontal nystagmus. Nervous system disorders: restlessness, overstimulation, agitation. 5 Post-Market Adverse Reactions Injury, Poisoning and Procedural Complications There have been reports of falls and fractures in benzodiazepine users due to adverse reactions such as sedation, dizziness and ataxia.

The risk is increased in those taking concomitant sedatives (including alcoholic beverages), the elderly and debilitated patients. Dependence/Withdrawal Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as RESTORIL.

1 Dosing considerations). 2 CONTRAINDICATIONS RESTORIL is contraindicated in patients:  with a known hypersensitivity to the drug, to other benzodiazepines or to any component of the drug’s formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.  with myasthenia gravis.  with sleep apnea syndrome.  who in the past manifested paradoxical reactions to alcohol and/or sedative medications. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, including RESTORIL, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.

Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol or illicit drugs.  Assess each patient’s risk prior to prescribing RESTORIL  Monitor all patients regularly for the development of these behaviours or conditions.

 RESTORIL should be stored securely to avoid theft or misuse. RESTORIL® (temazepam) Page 5 of 29 Withdrawal Benzodiazepines, like RESTORIL can produce severe or life-threatening withdrawal symptoms.  Avoid abrupt discontinuation or rapid dose reduction of RESTORIL.

 Terminate treatment with RESTORIL by gradually tapering the dosage schedule under close monitoring. (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant use with Opioids Concomitant use of RESTORIL and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS, General, Concomitant use with opioids).

 Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible.  Limit dosages and durations to the minimum required.  Follow patients for signs and symptoms of respiratory depression and sedation.

RESTORIL is contraindicated in patients:  with a known hypersensitivity to the drug, to other benzodiazepines or to any component of the drug’s formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

 with myasthenia gravis.  with sleep apnea syndrome.  who in the past manifested paradoxical reactions to alcohol and/or sedative medications.