Zolpidem Sandoz

Zolpidem tartrate

Short-term treatment of insomnia in adults in situations where insomnia is debilitating or causing severe distress.

10 mg daily taken immediately before bedtime w/ at least 7-8 hr before planned time of awakening. Max: 10 mg once daily.

Hypersensitivity. Obstructive sleep apnoea, myasthenia gravis, severe hepatic insufficiency, acute &/or severe resp depression. Psychotic illness. Childn.

Potential to cause severe allergic reactions & complex sleep-related behaviors. Risk of next-day psychomotor impairment if taken <8 hr before performing activities that require mental alertness; higher than recommended dose is taken; co-administered w/ other CNS depressants, drugs increasing zolpidem blood levels, alcohol or illicit drugs. Caution in patients w/ compromised resp function; hepatic insufficiency; elderly; history of drug or alcohol use; depression; concomitant use of opioids. Not recommended for primary treatment of psychotic illness. Risk of w/drawal phenomena or rebound insomnia after abrupt discontinuation. May induce anterograde amnesia. Discontinue if psychiatric & paradoxical reactions, somnambulism & associated behaviors occur. Tolerance & dependence may develop. Can cause drowsiness & decreased level of consciousness. Major influence on the ability to drive & use machines. Not recommended during pregnancy & in nursing mothers. Not recommended for use in childn & adolescents <18 yr.

Hallucination, agitation, nightmare, depression; somnolence, headache, dizziness, exacerbated insomnia, cognitive disorders eg, anterograde amnesia; diarrhoea, nausea, vomiting, abdominal pain; back pain; URTI, lower resp tract infection; fatigue.

Enhanced sedative effect w/ alcohol. Enhancement of central depressive effect w/ antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anaesth & sedative antihistamines. Increased blood levels w/ fluvoxamine, ciprofloxacin. Enhanced euphoria w/ narcotic analgesics. Increased risk of sedation, resp depression, coma & death w/ opioids. Enhanced activity w/ CYP450 inhibitors. Decreased pharmacodynamic effect w/ CYP3A4 inducer eg, rifampicin & St. John's Wort. Prolonged elimination t_½, increased total AUC, & decreased apparent oral clearance w/ ketoconazole (potent CYP3A4 inhibitor).

Hypnotics & Sedatives

N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.

P₁S₁S₃