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Sleep Aids and Hypnotics

Restoril (Temazepam) Oral Capsules

Restoril is a prescription oral benzodiazepine hypnotic containing temazepam. It is used in adults for the short-term treatment of insomnia, with a moderate half-life suited to sleep maintenance.

Restoril (Temazepam) 7.5mg capsule — medication photo
Active ingredients
Temazepam
Manufacturer
Mallinckrodt
Dosage forms
capsule
Available dosages
7.5mg, 15mg, 22.5mg, 30mg

What is it?

Restoril is the United States brand name for temazepam, currently marketed by Mallinckrodt. The product is supplied as oral capsules at four strengths and is dispensed only on prescription. Compared with newer non-benzodiazepine hypnotics, Restoril is a classical benzodiazepine, with the typical class effects on sedation, muscle relaxation and anxiety in addition to sleep induction.

Active ingredients

Each capsule contains temazepam as the sole active ingredient at 7.5mg, 15mg, 22.5mg or 30mg. Temazepam is a 1,4-benzodiazepine that potentiates GABA at the GABA-A receptor and has a moderate terminal half-life of 8 to 20 hours.

Forms and dosages

Restoril is administered orally about 30 minutes before going to bed. According to the prescribing information, the recommended starting dose is 7.5mg to 15mg in most adults, with up to 30mg used in selected cases. Older adults and patients with hepatic or respiratory impairment should generally start at the lower end. Capsules are swallowed whole with water; the medication should be used only when at least seven to eight hours of sleep are anticipated.

Indications

Restoril is approved in adults for the short-term treatment of insomnia, particularly when difficulty maintaining sleep is prominent. According to clinical guidelines, prescription should be limited to the lowest effective dose for the shortest period needed, typically two to four weeks, with periodic reassessment. Restoril is not indicated for chronic insomnia as a first-line approach, nor for paediatric patients.

How it works

Temazepam binds the benzodiazepine site of the GABA-A receptor and allosterically enhances inhibitory chloride conductance. Hyperpolarisation of central nervous system neurons produces sedation, sleep induction, prolongation of total sleep time and a reduction of nocturnal awakenings. The moderate half-life of 8 to 20 hours favours sleep maintenance throughout the night, with some next-day residue possible at higher doses or in older adults.

Frequently asked questions

Is Restoril better for sleep onset or sleep maintenance?

Restoril has a moderate half-life of 8 to 20 hours, which is longer than typical sleep-onset Z-drugs and supports sleep maintenance throughout the night. According to the prescribing information, the medication is taken about 30 minutes before bedtime and is most useful when difficulty maintaining sleep or early-morning awakening are prominent. The choice between hypnotics is made by the prescriber based on the type of insomnia and patient profile.

Can Restoril cause next-day sedation?

Yes. Because of its moderate half-life, some residual sedation can persist into the following morning, particularly with higher doses, in older patients or in slow metabolisers. This may impair driving and the operation of machinery. According to the prescribing information, the lowest effective dose should be used and patients should be cautious about activities requiring alertness on the day after treatment.

Is Restoril addictive?

Restoril, like other benzodiazepines, has a recognised potential for tolerance, physical dependence and withdrawal symptoms with chronic use, and a potential for misuse. The risk increases with higher doses, longer duration of treatment and concurrent substance use. According to the prescribing information, prescription should be limited to short-term use, with gradual tapering at the end of treatment to avoid rebound insomnia and other withdrawal symptoms.

Can Restoril be combined with alcohol or opioids?

No. Combining Restoril with alcohol, opioids or other central nervous system depressants increases the risk of severe sedation, respiratory depression, accidents and overdose. The combination of benzodiazepines and opioids is identified by several public health agencies as a major contributor to overdose mortality. According to the prescribing information, patients should disclose all concomitant medications and avoid alcohol.

What are the main contraindications for Restoril?

Restoril is contraindicated in known hypersensitivity to benzodiazepines, in severe respiratory insufficiency, in obstructive sleep apnoea, in narrow-angle glaucoma and in severe hepatic impairment. Caution is required in older adults, in patients with substance use disorders and during pregnancy, where benzodiazepines are generally avoided. According to the prescribing information, the medical history must be reviewed by a clinician before any prescription.

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The information on this website is provided for reference and educational purposes only. It does not replace consultation with a qualified healthcare professional.