Ambien CR for insomnia with difficulty falling or staying asleep

Ambien CR is an extended-release tablet formulation of zolpidem tartrate used to treat insomnia in adults, especially when patients have difficulty falling asleep or staying asleep. It is designed for once-daily oral administration immediately before bedtime and comes in 6.25 mg and 12.5 mg strengths.

Ambien CR is approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults. Clinical studies supporting its use include short-term trials up to three weeks and a 24-week patient-reported trial in adults. It is specifically indicated to help patients who have trouble falling asleep or staying asleep during the night.

zolpidem tartrate

Ambien CR contains zolpidem tartrate, which is a sedative-hypnotic that works by affecting neurotransmitters in the brain to induce and maintain sleep. Its extended-release formulation allows for an initial rapid onset to help with falling asleep and a continued release to aid sleep maintenance throughout the night.

Adults

The recommended dose is 12.5 mg taken once daily immediately before bedtime. The total daily dose should not exceed 12.5 mg.

Elderly, debilitated, or hepatic impaired patients

The dose should be reduced to 6.25 mg once daily immediately before bedtime due to increased sensitivity and slower drug clearance. These patients should be closely monitored.

Administration instructions

• Tablets must be swallowed whole; do not crush, chew, or divide.
• Should not be taken with or immediately after a meal, as food may delay the drug's effect.
• Dosage adjustments may be needed when combined with other central nervous system depressants due to additive effects.

Ambien CR is contraindicated in patients with known hypersensitivity to zolpidem tartrate or any inactive ingredients in the formulation. Hypersensitivity reactions have included anaphylaxis and angioedema.

Evaluation of underlying conditions

Insomnia lasting more than 7 to 10 days should prompt evaluation for underlying psychiatric or medical conditions before continuing treatment.

Serious allergic reactions

Rare cases of angioedema and anaphylaxis have been reported. If these occur, Ambien CR must be discontinued and not restarted.

Abnormal behaviors and complex sleep-related activities

Patients may experience hallucinations, agitation, bizarre behaviors, and complex activities such as "sleep-driving" with amnesia for the event. These behaviors increase with use of alcohol, other CNS depressants, or doses above recommended levels. Discontinuation should be considered if such behaviors are reported.

Depression and suicidal thoughts

Worsening of depression and suicidal ideation have been reported, especially in primarily depressed patients. Prescribe the minimum amount needed to reduce risk of intentional overdose.

Withdrawal effects

Rapid dose reduction or abrupt discontinuation can cause withdrawal symptoms similar to other CNS depressants.

CNS depressant effects

Ambien CR may impair alertness and motor coordination, affecting activities like driving or operating machinery. Avoid alcohol and use caution when combining with other CNS depressants.

Special populations caution

• Elderly and debilitated patients: More sensitive to sedation and cognitive impairment; use lower dose and monitor closely.
• Patients with hepatic impairment: Reduced clearance; initiate treatment at lower dose.
• Respiratory conditions: Use caution in patients with mild to moderate COPD, sleep apnea, or myasthenia gravis due to potential respiratory depression.
• Depression: Careful monitoring recommended.
• Pediatrics: Safety and efficacy not established; hallucinations reported in pediatric insomnia associated with ADHD.

Common adverse reactions

• Headache
• Next-day somnolence (drowsiness)
• Dizziness

Reactions leading to discontinuation

In clinical trials, 3.5% to 8.5% of adults discontinued Ambien CR due to adverse effects including somnolence, anxiety, restlessness, agitation, and depression. Anxiety and depression occurred more often than with placebo.

Serious adverse reactions

• Severe allergic reactions including anaphylaxis and angioedema
• Abnormal thinking and behavioral changes, including hallucinations and complex behaviors

Ambien CR's sedative effects can be increased when taken with alcohol or other central nervous system depressants. Dose adjustments may be necessary when combined with such agents due to additive effects. Concomitant use with alcohol is contraindicated.