Temazepam is a controlled substance. It is classified as a Schedule IV drug under the federal Controlled Substances Act, meaning it has a recognized medical use but carries a risk of dependence. The Drug Enforcement Administration (DEA) lists it specifically under Schedule IV depressants, assigned code number 2925.
What Schedule IV Means in Practice
The DEA uses five schedules to rank controlled substances, with Schedule I being the most restricted and Schedule V the least. Schedule IV drugs are considered to have a lower potential for abuse compared to Schedule III substances, but they still carry enough risk to require a prescription and government oversight. Other well-known Schedule IV drugs include other benzodiazepines like diazepam (Valium) and alprazolam (Xanax).
Because temazepam is Schedule IV, federal law places specific limits on how it can be prescribed and refilled. A prescription expires six months after the date it was written. Within that six-month window, you can receive a maximum of five refills. After that, your prescriber needs to write a new prescription.
Why Temazepam Is Controlled
Temazepam is a benzodiazepine, a class of drugs that works by boosting the activity of a calming brain chemical called GABA. When temazepam binds to receptors in the brain, it increases the flow of chloride ions into nerve cells. This makes those neurons less excitable, producing sedation, muscle relaxation, and reduced anxiety. That calming effect is what makes it useful for sleep, but it’s also what makes it habit-forming.
With regular use, the brain adjusts to the presence of the drug. Over time, higher doses may be needed to achieve the same effect, and stopping abruptly can trigger withdrawal symptoms like rebound insomnia, anxiety, and irritability. This physical dependence is the core reason temazepam requires controlled substance oversight. Prescribers are advised to gradually taper the dose rather than stopping it suddenly after extended use.
What Temazepam Is Prescribed For
Temazepam is FDA-approved to treat insomnia. It is sold under the brand name Restoril and comes in capsules of 7.5 mg, 15 mg, 22.5 mg, and 30 mg. The typical adult dose is 15 to 30 mg taken at bedtime. For older adults or people in fragile health, the starting dose is usually 7.5 mg, and use is generally limited to 10 to 14 days.
It is sometimes preferred over other benzodiazepines in older patients because it does not produce active metabolites. Some benzodiazepines break down into byproducts that continue affecting the brain for hours or even days. Temazepam does not, which means its sedating effects wear off more predictably.
Common Side Effects
In clinical trials involving over 1,000 patients, temazepam was generally well tolerated. The most frequently reported side effects were drowsiness (9.1% of patients), headache (8.5%), fatigue (4.8%), nervousness (4.6%), lethargy (4.5%), and dizziness (4.5%). A “hangover” feeling the next morning affected about 2.5% of users. Less common effects included confusion (1.3%), euphoria (1.5%), and blurred vision (1.3%). Most side effects were mild and temporary.
Dangerous Interactions
The most serious risk with temazepam involves combining it with other substances that depress the central nervous system. Mixing benzodiazepines with opioid painkillers can cause profound sedation, dangerously slow breathing, coma, and death. Observational studies have shown that using opioids and benzodiazepines together increases the risk of drug-related death compared to using opioids alone.
Alcohol is another major concern. Drinking while taking temazepam intensifies sedation and has been linked to complex sleep behaviors like sleep-driving, where a person gets behind the wheel while not fully awake and has no memory of it afterward. The FDA label explicitly warns against alcohol use during treatment. Other sedating medications, including antihistamines and certain antidepressants, can also amplify these risks.
Temazepam is contraindicated during pregnancy. Benzodiazepines can cause harm to a developing fetus.
Legal Status Outside the US
Temazepam’s controlled status is not unique to the United States. In the United Kingdom, it is classified as a Class C drug under the Misuse of Drugs Act and placed in Schedule 3 of the Misuse of Drugs Regulations. This means it requires a prescription and is subject to additional record-keeping and storage requirements beyond what standard prescription medications need. In several other countries, including Australia and parts of Europe, temazepam is similarly regulated more tightly than many other benzodiazepines due to its history of misuse.