What the label lists and what reports show
Temazepam side effects
Temazepam's FDA label lists its adverse reactions in its own words. FAERS holds 37,475 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (2,832 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the temazepam FDA label on DailyMed (effective June 9, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of RESTORIL?RESTORIL may cause serious side effects, including: See “What is the most important information I should know about RESTORIL?” Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts. Severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help right away if you have these symptoms after taking RESTORIL. RESTORIL can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how RESTORIL affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking RESTORIL without first talking to your healthcare provider. […]
Source: FDA drug label, SpecGx LLC, effective June 9, 2026 (SPL set bc56f7fd-1aaf-48ff-8aa7-d467e59e1015), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsDuring controlled clinical studies in which 1076 patients received Restoril at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Restoril % Incidence (n=1076) Placebo % Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2.0 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System – anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular – dyspnea, palpitations Gastrointestinal – vomiting …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Restoril % Incidence (n=1076) | Placebo % Incidence (n=783) |
|---|---|---|
| Drowsiness | 9.1 | 5.6 |
| Headache | 8.5 | 9.1 |
| Fatigue | 4.8 | 4.7 |
| Nervousness | 4.6 | 8.2 |
| Lethargy | 4.5 | 3.4 |
| Dizziness | 4.5 | 3.3 |
| Nausea | 3.1 | 3.8 |
| Hangover | 2.5 | 1.1 |
| Anxiety | 2.0 | 1.5 |
| Depression | 1.7 | 1.8 |
| Dry Mouth | 1.7 | 2.2 |
| Diarrhea | 1.7 | 1.1 |
| Abdominal Discomfort | 1.5 | 1.9 |
| Euphoria | 1.5 | 0.4 |
| Weakness | 1.4 | 0.9 |
| Confusion | 1.3 | 0.5 |
| Blurred Vision | 1.3 | 1.3 |
| Nightmares | 1.2 | 1.7 |
| Vertigo | 1.2 | 0.8 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, SpecGx LLC, effective June 9, 2026 (SPL set bc56f7fd-1aaf-48ff-8aa7-d467e59e1015), via openFDA; the full label on DailyMed
What do FAERS reports show?
37,475 reports list temazepam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,537 are coded as a death and 12,572 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Temazepam: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions