What is the efficacy of hydroxyzine for insomnia and anxiety disorder?

From the Guidelines

Hydroxyzine should not be considered a first-line treatment for sleep difficulties or anxiety due to the availability of more effective and safer alternatives, such as cognitive behavioral therapy for insomnia (CBT-I) or other non-pharmacologic interventions. For anxiety, typical dosing ranges from 25-50mg taken up to four times daily as needed, while for sleep, a single dose of 25-50mg taken 30 minutes before bedtime is commonly used 1. Hydroxyzine works by blocking histamine receptors in the brain, which produces a calming and sedating effect. Unlike benzodiazepines, it's not habit-forming and doesn't cause physical dependence, making it suitable for longer-term use. However, the potential benefits of hydroxyzine are outweighed by the potential harms and burden of pharmacotherapy, particularly when compared to CBT-I, which has been shown to be more effective in the long-term and has fewer adverse effects 1. Common side effects of hydroxyzine include drowsiness, dry mouth, and dizziness, with the drowsiness being beneficial for sleep but potentially problematic during daytime use for anxiety. Hydroxyzine should be used cautiously in older adults and those with certain medical conditions like glaucoma or urinary retention. It's also important to avoid alcohol and other central nervous system depressants while taking hydroxyzine as this can increase sedation.

Some key points to consider when evaluating the use of hydroxyzine for sleep and anxiety include:

• The lack of clear harms data for pharmacologic treatments beyond relatively brief treatment periods, which raises concerns about potential increased risks with longer courses of pharmacotherapy 1
• The superiority of CBT-I over pharmacotherapy in long-term outcomes for chronic insomnia disorder 1
• The potential for sleep hygiene education alone to be ineffectual or even harmful if patients receiving it as treatment for chronic insomnia disorder are less receptive to referral for effective behavioral treatments, such as CBT-I or BBT-I 1
• The importance of considering non-pharmacologic behavioral interventions as first-line treatments for chronic insomnia disorder and anxiety, given their greater effectiveness and safety compared to pharmacologic therapies 1.

From the FDA Drug Label

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. As a sedative when used as a premedication and following general anesthesia, The primary use of hydroxyzine includes:

• Symptomatic relief of anxiety and tension
• Sedative use as a premedication and following general anesthesia Hydroxyzine can be used for anxiety and as a sedative, which may help with sleep. However, the label does not explicitly mention its use for sleep. 2

From the Research

Hydroxyzine for Sleep and Anxiety

• Hydroxyzine is an anti-histamine medication that has been used in the treatment of anxiety and sleep disorders 3, 4, 5, 6.
• Studies have shown that hydroxyzine is effective in alleviating the acute symptoms of generalized anxiety disorder (GAD) and improving sleep quality 3, 4, 5, 6.
• Compared to placebo, hydroxyzine has been shown to be more effective in reducing anxiety symptoms and improving sleep outcomes 3, 5, 6.
• Hydroxyzine has also been compared to other anxiolytic agents, such as benzodiazepines and buspirone, and has been found to be equivalent in terms of efficacy, acceptability, and tolerability 3, 5.
• However, hydroxyzine has been associated with a higher rate of sleepiness/drowsiness compared to other active comparators 3.
• The safety profile of hydroxyzine is generally considered to be favorable, with the most common adverse drug effect being dry mouth 6.

Efficacy of Hydroxyzine for Sleep

• A systematic review of five studies found mixed efficacy of hydroxyzine for sleep measures, including sleep onset, sleep maintenance, and sleep quality 6.
• The review suggested that hydroxyzine could be considered as a short-term treatment option for adults with insomnia who have not responded to previous therapy or have contraindications to other treatments 6.
• However, additional long-term studies with an active comparator are needed to further establish the role of hydroxyzine in insomnia treatment 6.

Efficacy of Hydroxyzine for Anxiety

• A study published in 2010 found that hydroxyzine was more effective than placebo in reducing anxiety symptoms in patients with GAD 3.
• Another study published in 1998 found that hydroxyzine was effective in reducing anxiety symptoms and improving sleep quality in patients with GAD 4.
• A study published in 2002 found that hydroxyzine was effective in reducing anxiety symptoms and improving sleep quality in patients with GAD, and was equivalent to bromazepam in terms of efficacy and safety 5.
• Hydroxyzine has also been mentioned as a potential treatment option for other anxiety disorders, such as obsessive-compulsive disorder and panic disorder 7.