Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam 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: Temazepam % 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 Musculoskeletal – backache Special Senses – hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam, and opioids may result in profound sedation, respiratory depression, coma, and death.
Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe temazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
In patients already receiving an opioid analgesic, prescribe a lower initial dose of temazepam than indicated in the absence of an opioid and titrate based on clinical response.
Like all medications, Temazepam can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: