Usual Adult Dose for Insomnia

10 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

• Maximum dose: 20 mg/day

Comments:

• Doses should be individualized.
• Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Usual Geriatric Dose for Insomnia

5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

• Maximum dose: 10 mg/day

Comments:

• Doses should be individualized.
• Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Renal Dose Adjustments

Mild to Moderate Renal Dysfunction: No adjustment recommended.
Severe Renal Dysfunction: Data not available

Liver Dose Adjustments

Mild to Moderate Liver Dysfunction: 5 mg orally once a day immediately before bedtime OR after going to bed and having trouble falling asleep
Severe Liver Dysfunction: Not recommended.

Dose Adjustments

Debilitated Patients and/or Low Weight Patients: 5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

• Maximum dose: 10 mg/day

Comments:

• Doses should be individualized.
• Efficacy was established in trials ranging from a single night to 5 weeks.

Concomitant Use with Cimetidine:

• Initial dose: 5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep

Patients with Compromised Respiration Due to Preexisting Conditions: Frequent monitoring recommended.

Patients with Concomitant Illness(es): Use with caution in disease states or with the concomitant use of drugs that could affect metabolism or hemodynamic response.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or to any of the ingredients
• Patients who have previously experienced an episode of complex sleep behaviors after taking this drug

US BOXED WARNINGS:
COMPLEX SLEEP BEHAVIORS:

• Complex sleep behaviors including sleepwalking, sleep-driving, and engaging in other activities while not fully awake may occur following the use of this drug.
• Some of these events may result in serious injuries, including death.

Recommendation:

• Discontinue this drug immediately if the patient experiences a complex sleep behavior.

Safety and efficacy have not been established in pediatric patients.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be taken immediately prior to bedtime or after the patient has gone to bed and is having trouble falling asleep.
• Patients should avoid taking this drug with/immediately after consuming a heavy, high-fat meal, as slower absorption may reduce the effect of this drug on sleep latency.

Storage requirements:

• Protect from light.

General:

• In clinical trials, this drug decreased the time to sleep onset for up to 30 days; however, it was not shown to increase the total sleep time or decrease the number of awakenings.

Monitoring:

• NERVOUS SYSTEM: Changes in cognitive function, including complex behaviors
• PSYCHIATRIC: New/worsening depression
• RESPIRATORY: Respiratory function in patients with compromised respiratory function

Patient advice:

• Patients should be instructed to immediately report "sleep driving," other complex behaviors, and any new/worsening signs/symptoms of depression.
• Inform patients that this drug may cause blurred vision, dizziness, impaired coordination, short-term memory impairment, and/or somnolence, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• Is “Ambien-Tweeting” a Thing?