Prescribing Hydroxyzine (Atarax) for Short‑Term Insomnia: Patient Counseling and Instructions
Hydroxyzine is NOT a first‑line or guideline‑recommended agent for insomnia; cognitive‑behavioral therapy for insomnia (CBT‑I) must be initiated first, and if medication is required, FDA‑approved hypnotics (e.g., low‑dose doxepin 3–6 mg, eszopiclone, or ramelteon) are preferred over hydroxyzine. 1, 2
Why Hydroxyzine Is Not Recommended for Insomnia
The American Academy of Sleep Medicine explicitly recommends against over‑the‑counter antihistamines (including hydroxyzine) for insomnia because efficacy data are lacking, anticholinergic side effects are common (confusion, urinary retention, falls, daytime sedation, delirium), and tolerance develops within 3–4 days of use. 1, 2
Guideline societies position hydroxyzine as a non‑evidence‑based option; it does not appear in any major insomnia treatment algorithm, and its use is discouraged in elderly patients due to strong anticholinergic burden and fall risk. 1
A 2023 systematic review of hydroxyzine for sleep in adults found only mixed efficacy across five small trials (total N = 207), with no consistent improvement in sleep onset, maintenance, or quality, and most studies did not report safety outcomes. 3
Mandatory First‑Line Treatment: Cognitive‑Behavioral Therapy for Insomnia (CBT‑I)
The American Academy of Sleep Medicine and the American College of Physicians issue a strong recommendation that all adults with chronic insomnia receive CBT‑I as the initial intervention before any medication, because it provides superior long‑term efficacy and sustained benefits after treatment ends. 1, 2
Core CBT‑I components include stimulus control (use bed only for sleep, leave bed if unable to sleep within ~20 minutes), sleep restriction (limit time in bed to actual sleep time + 30 minutes), relaxation techniques (progressive muscle relaxation, guided imagery), and cognitive restructuring of negative sleep beliefs. 1
CBT‑I can be delivered via individual therapy, group sessions, telephone, web‑based modules, or self‑help books, making it accessible even when resources are limited. 1
If Pharmacotherapy Is Required After CBT‑I Initiation
First‑Line FDA‑Approved Options (NOT Hydroxyzine)
| Agent | Dose | Indication | Key Efficacy | Evidence Level |
|---|---|---|---|---|
| Low‑dose doxepin | 3–6 mg at bedtime | Sleep‑maintenance insomnia | Reduces wake after sleep onset by 22–23 min; minimal anticholinergic effects; no abuse potential | Guideline‑recommended [1,2,4] |
| Eszopiclone | 2–3 mg (1 mg if age ≥65 y) | Combined sleep‑onset & maintenance | Increases total sleep time by 28–57 min; moderate‑to‑large improvement in sleep quality | Guideline‑recommended [1,2] |
| Ramelteon | 8 mg at bedtime | Sleep‑onset insomnia | Melatonin‑receptor agonist; no abuse potential; no DEA scheduling | Guideline‑recommended [1,2] |
| Zolpidem | 10 mg (5 mg if age ≥65 y) | Sleep‑onset & maintenance | Shortens sleep latency by ~25 min; adds ~29 min to total sleep time | Guideline‑recommended [1,2] |
| Zaleplon | 10 mg (5 mg if age ≥65 y) | Sleep‑onset insomnia | Ultrashort half‑life (~1 h); minimal next‑day sedation | Guideline‑recommended [1,2] |
If Hydroxyzine Is Prescribed Despite Guideline Recommendations
Dosing and Administration
Start hydroxyzine 25 mg at bedtime for short‑term use (≤7–10 days); doses of 50 mg or 100 mg have been studied but carry higher anticholinergic burden without proportional sleep benefit. 5, 3
Take 30 minutes before bedtime with at least 7 hours remaining before planned awakening to minimize next‑day sedation. 6
Elderly patients should start at the low end of the dosing range (12.5–25 mg) due to increased sensitivity, greater frequency of decreased hepatic/renal function, and higher risk of confusion and falls. 6
Critical Safety Warnings (FDA Black‑Box and Guideline Alerts)
QT prolongation and Torsades de Pointes: Hydroxyzine prolongs the QTc interval and has caused life‑threatening arrhythmias, especially in patients with pre‑existing heart disease, electrolyte imbalances, or concurrent use of other QT‑prolonging drugs (e.g., citalopram, azithromycin, methadone, antipsychotics). 6
Avoid hydroxyzine in patients with:
- Congenital long QT syndrome or family history of long QT syndrome 6
- Recent myocardial infarction, uncompensated heart failure, or bradyarrhythmias 6
- Concurrent use of Class IA (quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmics 6
- Concurrent use of other QT‑prolonging agents (certain antipsychotics, antidepressants, antibiotics, methadone) 6
Central nervous system (CNS) depression: Hydroxyzine potentiates the effects of narcotics, non‑narcotic analgesics, barbiturates, and alcohol; patients must avoid alcohol and other CNS depressants while taking hydroxyzine. 6
Driving and machinery: Drowsiness is common; patients must be warned against driving or operating dangerous machinery until they know how hydroxyzine affects them. 6
Acute Generalized Exanthematous Pustulosis (AGEP): Hydroxyzine may rarely cause AGEP, a serious skin reaction with fever and sterile pustules; discontinue immediately if a rash appears and do not resume hydroxyzine. 6
Anticholinergic effects: Dry mouth, urinary retention, constipation, confusion, and delirium are common, especially in elderly patients; monitor closely for these symptoms. 1, 6
Tolerance develops within 3–4 days: Hydroxyzine loses efficacy rapidly with nightly use, making it unsuitable for chronic insomnia. 1
Monitoring and Reassessment
Reassess sleep parameters after 1–2 weeks: If no improvement in sleep onset, total sleep time, or daytime functioning, discontinue hydroxyzine and switch to a guideline‑recommended hypnotic. 1, 3
Obtain a baseline ECG if risk factors for QT prolongation are present; monitor QTc interval and discontinue if QTc exceeds 500 ms or rises by >60 ms from baseline. 6
Screen for excessive sedation, confusion, falls, and respiratory depression during the first 24–48 hours after initiation. 6
Duration of Use
Limit hydroxyzine to short‑term use (≤7–10 days) because tolerance develops rapidly and long‑term safety data are absent. 1, 3
If insomnia persists beyond 7–10 days, evaluate for underlying sleep disorders (e.g., sleep apnea, restless‑legs syndrome, circadian‑rhythm disorders) and switch to a guideline‑recommended hypnotic. 1
Common Pitfalls to Avoid
Prescribing hydroxyzine without first implementing CBT‑I contravenes strong guideline recommendations and forfeits the more durable benefits of behavioral therapy. 1, 2
Using hydroxyzine in elderly patients despite explicit warnings about anticholinergic toxicity, confusion, falls, and delirium. 1, 6
Combining hydroxyzine with other CNS depressants or QT‑prolonging drugs markedly increases the risk of respiratory depression, arrhythmias, and sudden cardiac death. 6
Continuing hydroxyzine beyond 7–10 days despite rapid tolerance development and lack of long‑term efficacy data. 1, 3
Failing to counsel patients about driving impairment and alcohol avoidance, which are FDA‑mandated safety warnings. 6
Patient Counseling Checklist
Explain that hydroxyzine is not a first‑line treatment and that CBT‑I is the standard of care for insomnia. 1, 2
Instruct the patient to take hydroxyzine 25 mg 30 minutes before bedtime with at least 7 hours remaining before awakening. 6, 3
Warn about drowsiness and driving impairment; advise against driving or operating machinery until the patient knows how hydroxyzine affects them. 6
Prohibit alcohol and other CNS depressants (including opioids, benzodiazepines, and barbiturates) while taking hydroxyzine. 6
Counsel about anticholinergic side effects (dry mouth, urinary retention, constipation, confusion) and instruct the patient to report these immediately. 6
Advise the patient to discontinue hydroxyzine and seek immediate care if a rash, fever, or pustules develop (AGEP warning). 6
Inform the patient that hydroxyzine is for short‑term use only (≤7–10 days) and that tolerance develops rapidly. 1, 3
Schedule a follow‑up visit after 1–2 weeks to reassess sleep parameters and consider switching to a guideline‑recommended hypnotic if hydroxyzine is ineffective. 1, 3